2016 Laboratory Guidelines

Laboratory Quality Assurance Program
College of Physicians & Surgeons of Saskatchewan
Laboratory
Guidelines
General
Anatomic Pathology
Chemistry
Hematology
2016 Edition
LABORATORY GUIDELINES 2016

SUMMARY OF CHANGES
The following GUIDELINES have been revised, added, or deleted:

REVISED:
2016
Recommended Resources for Laboratories (previously Reference Textbook List for Laboratories)
Retention Guideline
2015
Specimens Exempt From All Gross &/or Microscopic Pathology Laboratories
2014
Differential Performance and Referral Practice Guidelines
2013
Reference Textbook List for Laboratories

Urinalysis
Retention Guideline
eGFR
Differential Quality Control
Procedure for WBC Estimate
2012
Performance of Whole Blood Glucose Testing

Urinalysis
Retention Guideline
Differential Performance & Referral Practice Guideline
ADDED:
2016
Balances
Centrifuge Operating Speeds
Competency
Documents
Duties of Medical Laboratory Assistant
Pipettes
POCT HIV Quality Control
Quality Control
Temperature Monitoring
Thermometers
Visual Color Discrimination
Manual ESR QC
2015
Fluid Review by Pathologist
2013
International Sensitivity Index (ISI) Verification

Verifying or Establishing a Normal Reference Range for Routine Coagulation Testing
2012
Reference Textbook List

Indirect Platelet Count
Procedure for Platelet Estimate
Establishing Conversion Factor for PLT Estimation
Establishing Conversion Factor for WBC Estimation
Protocol for Validation of Linearity on Automated Hematology Analyzers
Laboratory Guidelines 2016 Edition
Page 1
DELETED:
2016
Retention of Transfusion Medicine Records
Performance of Non-Gynecological Cytology
Follow-up Reports for Gynecological Cytology
Follow-up Program for Cytology
Cholesterol/Triglyceride/Lipid Testing
Reporting Sperm in Urine
Quality Control
Diagnosis and Monitoring of Thyroid Disease
Presence of Small Amounts of Albumin
Principles for Hematology Practice
Hematology Films/Labeling of Slides
Morphology of Lymphocytes
Flow Cytometry for the Diagnosis of Lymphoma/Leukemia
Malaria
3.2% Na Citrate Anticoagulant Recommended vs. 3.8% for Coagulation Studies
Procedure/Method Statistical Validation/Work-up Guidelines
2015
Surgical Pathology Reports

Urinalysis
Bleeding Time
2014
Erythrocyte Sedimentation Rate (ESR)
2013
Performance of Whole Blood Glucose Testing

D-dimer
Semen/Sperm Analysis
Page 2
Table of Contents
General
Retention Guideline
Recommended Resources for Laboratories
Balances
Centrifuge Operating Speeds
Competency
Documents
Duties of Medical Laboratory Assistant
POCT HIV Quality Control
Pipettes
Quality Control
Temperature Monitoring
Thermometers
Visual Color Discrimination
5
8
10
11
12
13
14
15
16
17
18
19
20
Specimens Exempt from all Gross &/or Microscopic Pathology Laboratories

Removal of Tissue, Blocks or Slides from the Original Hospital Site
22
24
Estimated Glomerular Filtration Rate eGFR

Crosscheck/Validation Guideline for Those Facilities with Multiple Chemistry Instruments
Procedure/Method Statistical Work-up/Validation Study Guidelines
27
28
29
Differential Performance and Referral Practice Guideline

Red Blood Cell Morphology Reporting Guideline
Differential Quality Control
Smudge Cells
Crosscheck Validation Guideline for Facilities with Multiple Hematology Instruments
Procedure/Method Statistical Work-up/Validation Study Guidelines
Protocol for Validation of Linearity on Automated Hematology Analyzers
Establishing Conversion Factor for WBC Estimation
Procedure for Platelet Estimates
Establishing Conversion Factor for Platelet Estimation
Indirect Platelet Count
International Sensitivity Index (ISI) Verification
Verifying or Establishing a Normal Reference Range for Routine Coagulation Testing
Fluid Review by Pathologist
Manual ESR QC
32
34
35
38
39
40
42
45
47
49
51
53
55
56
59
60
Anatomic Pathology
Chemistry
Hematology
Page 3
GENERAL
Page 4
RETENTION GUIDELINE
Laboratories vary in size, facility and extent of services provided. Clinical laboratories must maintain
thorough, accessible records that can demonstrate an acceptable standard of care and compliance with
the accreditation requirements.
The Laboratory Quality Assurance Program of the College of Physicians and Surgeons urges laboratories
to retain records, materials, or both for a longer period of time than specified for educational and
quality improvement needs.
Laboratories must establish policies that meet or exceed the following minimum requirements for
retention of documents and specimens as established by professional and/or regulatory organizations.
References include: CSTM, CSCC, CAP, CSA, ISO, CPSS
Page 5
Record Retention
Storage Time
Hematology
Biochemistry
Microbiology
Accession record
Worksheets
Instrument print-outs
Paper copy of patient reports
1 year
1 year
1 year
3 months
1 year
1 year
1 year
3 months
Quality Control (QC)

PT documents
Calibration
Maintenance records
2 years
2 years
Service records
Method /instrument evaluation
Procedure Manual
Technologist ID & initials
log/computer
Telephone logs
Requisition
Laboratory Information Systems
Records
- Validation records, including
transmission of results and
calculations
- Database changes
- Hardware and software
modifications
- LIS downtime and corrective action
Biomedical Waste
Life of the instrument, plus 2 years

2 years after the method has been discontinued
2 years after procedure has been discontinued
1 year
1 year
1 year
1 year
1 year
3 months
3 months
2 years
3 months
5 years
2 years
1 year
1 year
1 year
3 months
Cytopathology
2 years
6 months
n/a
indefinite
Surgical
Pathology
2 years
6 months
n/a
indefinite
2 years
2 years
2 years
2 years
2 years
2 years
Life of the instrument, plus 2

years
3 months
3 months
2 years
3 months
1 year
2 years
3 months
5 years
2 years
Manifests must be retained for a minimum of 1 year
Page 6
Specimen Retention
Hematology
Chemistry
Microbiology
Cytopathology
Peripheral Blood
Smear
-7days
Whole blood,
serum &
plasma
- 48 hrs after
report has
been finalized
Swabs or
specimens
- 24 hrs after
report has been
finalized
Slides
negative/unsatis
factory
- 5 years
Peripheral Blood
Smear reviewed
by a pathologist
-1 year
Semen smears
- 3 months
Bone Marrow
Slides/Reports
- 20 yrs (adults)
- 50 yrs
(children)
Whole
blood/Plasma
- 24 hrs after
report has been
finalized
Body fluids
- 48 hrs after
report has been
finalized
Body fluids
- 48 hrs after
report has
been finalized
Urine - routine
- 24 hrs after
report has
been finalized
24hr Urines
- samples
discarded 48
hrs after
report has
been finalized
Positive Blood
Culture
- 5 days after
reporting
Gram Stain
- one week or
until final
report is sent
Ova & Parasite
slides
- one month
Slides
suspicious/pos
- 20 years
Fine-needle
aspiration slides
- 20 years
Cytology
Consultation/
Requisition
- Indefinitely
Male fertility
slides
- 1 year
Cytology paraffin
blocks
- 20 years
Surgical
Pathology
Blocks & slides
- 20 yrs (adults)
- 50 yrs (children)
Autopsy
- 20 yrs
Gross specimen
- min. 8 weeks
after issue of
report
Wet Autopsy
Tissue
- 8 weeks after
issue of report
Bone Marrow
Slides/ Reports
- 20 yrs (adults)
- 50 yrs (children)
Photographic
Transparencies
indexed and kept
indefinitely
Urine Smear for

Eosinophils
- 24 hrs after
report has been
finalized
- Urine Specimen
1 week
Page 7
RECOMMENDED RESOURCES FOR LABORATORIES

Microbiology
1) Manual of Clinical Microbiology (most recent version)
2) Bailey & Scott's Diagnostic Microbiology (most recent version)
3) Clinical Microbiology Procedures Handbook (most recent version)
4) Several links to useful websites can be found here: http://clinmicro.asm.org/index.php/benchwork-resources
Transfusion Medicine
1) Health Canada, Blood Regulations and the guidance document (most recent version)
2) Circular of Information, Canadian Blood Services (most recent version)
3) Canadian Standards Association Blood and Blood Component Z902 (most recent version)
4) Canadian Society for Transfusion Medicine (most recent version)
5) Modern Blood Banking and Transfusion Practices 6th Edition; Harmening, Denise M.
6) Canadian Medical Association Journal Guidelines for Red Blood Cell and Plasma Transfusion for
Adults and Children; supplement to CAN MED ASSOC J 1997;
156 (11)
7) American Association of Blood Banks Technical Manual (most recent edition)
8) Bloody Easy 3: Blood Transfusions, Blood Alternatives and Transfusion Reactions 3rd Edition; Ontario
Regional Blood Coordinating Network
9) Saskatchewan Emergency Blood Management Plan (most recent version)
10) Saskatchewan Transfusion Medicine Resource Manual (most recent version)
Hematology
1) Color Atlas of Hematology, Hematology and Clinical Microscopy Resource Committee, CAP; Glassy,
Eric F.
2) Clinical Hematology: principles, procedures, correlations 2nd edition; Stiene-Martin, LotspeichSteininger, Koepke
3) Hematology: Clinical Principles and Applications 4th Edition; Rodak, Fritsma, Doig
4) Clinical Hematology Atlas 4th Edition; Carr/Rodak
Page 8
Chemistry
1) Tietz Fundamentals of Clinical Chemistry 6th Edition, W. B. Saunders Company; Burtis, Ashwood,
Bruns
2) Clinical Chemistry Principles, Procedures, Correlations 6th Edition; Bishop
Urinalysis
1) Graffs Textbook of Urinalysis and Body Fluids 2nd Edition; Mundt, Shanahan
Anatomic Pathology
1) Histotechnology: A Self Instructional Text 3rd Edition; Carson & Hladik
2) Principles of Anatomy & Physiology 13th Edition; Tortora & Grabowski
Safety
1) Transportation of Dangerous Goods Act and Regulations
Supplement Canada Gazette, Part II [www.tc.gc.ca/eng/tdg/clear-tofc-211.htm]
2) CSMLS Guidelines Laboratory Safety, 7th Edition
Competency Evaluation
1) Canadian Society of Medical Laboratory Science
PO Box 2830 LCD 1
Hamilton, ON L8N 3N8
website www.csmls.org
Certification - Competency Profiles
Page 9
BALANCES
Balances should be mounted on vibration free benches and serviced annually.
Accuracy should be verified when a new balance is installed or when moved.
Verification of accuracy must be performed on a regular schedule.
For balances used for weighing materials to make standard solutions the balance should be checked
every 6 months.
Weights should be well maintained and only be handled by devices that will not allow residual
contaminants to remain on them.
References:
CAP Laboratory Accreditation Program. Chemistry and Toxicology Laboratory Checklist. Northfield, IL: 07.28.2015.
Page 10
CENTRIFUGE OPERATING SPEEDS

Records of verification of operating speeds (RPM) should be documented at a minimum of once per
year.
References:
CAP Laboratory Accreditation Program. General Laboratory Checklist. Northfield, IL: 07.28.2015.
Page 11
COMPETENCY
The competency of each person performing testing must be assessed.
Prior to starting patient testing and prior to reporting patient results for new instruments or methods
each individual must have training and be evaluated for acceptable test performance.
Competency assessment should be performed annually.
Competency should be documented.
Elements of competency assessment include but are not limited to:
1. Direct observations of routine patient test performance, including, as applicable, 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 preventative maintenance records.
4. Direct observation of performance of instrument maintenance and function checks.
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.
References:
CAP Laboratory Accreditation Program. Point of Care Testing Laboratory Checklist. Northfield, IL: 07.28.2015.
Page 12
DOCUMENTS
Policies, Processes, Procedures
New documents should be reviewed by the laboratory director or designate prior to implementation.
Documented review of all documents by the laboratory director or designate should occur every two
years.
Laboratory personnel should be knowledgeable about contents of policies and procedure relevant to
their scope of examination activities.
References:
CAP Laboratory Accreditation Program. All Common Checklist. Northfield, IL; 07.28.2015.
Page 13
DUTIES OF MEDICAL LABORATORY ASSISTANT (MLA) OR LAB ASSISTANT (LA)

A medical laboratory assistant may, under the qualified laboratory professional, perform a list of tasks
that are considered pre-examination and post-examination, and do not require interpretation or
assessment.
*Duties and training of MLAs vary from facility to facility; therefore it is the responsibility of the
employer to confirm competence.
Examples of tasks may include:
blood sample procurement
sample preparation for analysis, may include centrifugation, separation, numbering, aliquoting
reagent preparation/preparation of kits
media preparation
smear preparation, e.g. blood films
staining of smears/slides for hematology, etc.
coverslipping of slide preparations
concentration of stool samples for parasitology examinations
planting and streaking of microbiology specimens and controls
set up of anaerobic and CO 2 jars
titrations using a pH meter
urinalysis (excluding microscopic)
loading of primary tube to automated instruments
set up of erythrocyte sedimentation rates
temperature monitoring of thermally controlled equipment
filing of records and retrieval of files
wash-up and glassware
record but not report results (ESR, pregnancy test)
Page 14
HIV POCT QUALITY CONTROL

The controls are used to verify test performance and interpretation of results. Kit controls should be run
under the following circumstances:
For new INSTI user verification

When switching to new lot number of INSTI test kits
If a site conducts >24 point-of-care tests per day, the controls should be run everyday
If a site conducts <24 point-of-care tests per day, the controls should be run
approximately once per 24 specimens, but no less than once per week
If a site does no point-of-care tests in a given week, controls do not have to be run in
that week. However, controls must be run prior to conducting a client test, if it has
been a week since the last controls were run
References:
Guidelines for the Use of HIV Point of Care (POC) Test Kits in Saskatchewan (most current version)
Page 15
PIPETTES
Verification of pipettes used for quantitative dispensing should occur prior to being placed into service
and at least annually.
References:
Page 16
QUALITY CONTROL (QC)

Testing personnel must run and review quality control results to ensure acceptability prior to reporting
patient results.
Controls are run at least daily, or more frequently if specified by manufacturer.
Daily quality control should be run as follows:
Quantitative tests 2 controls at 2 different concentrations
Qualitative tests a negative and positive control
Controls are run:
Prior to reporting patient results

After change of reagents
After preventative maintenance
Change of instrument component
If an internal quality control process (e.g. electronic/procedural/built-in) is used, the laboratory must
have a quality control plan to address the internal quality control process.
External Quality Control analyzed:
Every 31 days
With each new lot number
With new shipments of reagents
At a frequency recommended by the test manufacturer
References:
CAP Laboratory Accreditation Program. Point of Care Testing Laboratory Checklist. Northfield, IL: 07.28.2015.
CAP Laboratory Accreditation Program. All Common Checklist. Northfield, IL: 07.28.2015.
Page 17
TEMPERATURE MONITORING
Temperature dependent equipment (refrigerators, freezers, incubators) containing reagents and/or
specimens should be monitored daily.
Room temperature should be documented daily.
Water baths and heat blocks only need to be checked on days of use.
The Laboratory director or designate should review temperature charts monthly.
References:
Page 18
THERMOMETERS
Thermometric standard devices should be recalibrated, recertified, or replaced prior to the expiry date
of guaranteed calibration.
Non-certified thermometers used should be checked against a thermometric standard device before
initial use and annually.
References:
Page 19
VISUAL COLOR DISCRIMINATION

Personnel performing testing that require color discrimination should be evaluated for visual color
discrimination.
This evaluation should be documented.
http://colorvisiontesting.com
References:
Page 20
ANATOMIC PATHOLOGY
Page 21
SPECIMENS EXEMPT FROM ALL GROSS &/OR MICROSCOPIC PATHOLOGY LABORATORIES

Irrespective of the exemptions listed below, gross &/or microscopic examinations will be performed
whenever the attending physician requests it, or at the discretion of the pathologist when indicated by
gross findings.
SPECIMEN TYPE
Abdominal pannus
Accessory Digits
Amputation
Bone or cartilage removed from the arthritic
joints during joint replacement surgery
Bone segments removed as part of corrective
orthopedic procedures (for example: rotator
cuff, synostosis repair, spinal fusion)
Bunions and hammer toes
Calculi (renal bladder etc.), are sent for chemical
analysis and description
Disc Materials
Extraocular muscle from corrective surgical
procedures (strabismus repair)
Femoral head removed for prosthesis (if straight
forward)
Foreign bodies, such as bullets or medicoloegal
evidence that is given directly to law
enforcement personnel
Gangrenous and traumatized limbs
Intrauterine contraceptive devices without
attached soft tissue
Loose bodies (joint)
Medical devices such as catheters, gastrostomy
tubes, myringotomy tubes, stents and sutures
that have not contributed to patient illness,
injury or death
Middle ear ossicles
Nasal bone and cartilage from rhinoplasty or
septoplasty
Orthopedic hardware and other radioopaque
mechanical devices provided there is an
alternative policy for documentation
Placentas which do not meet the criteria for
examination
Prosthetic breast implants
Prosthetic cardiac without attached tissue
DISCRETIONARY
GROSS &/OR MICROSCOPIC
(By Chemistry Dept.)
Page 22
SPECIMEN TYPE
Rib segments or other tissue removed only for
the purpose of gaining surgical access from
patients who do no have a history of malignancy
Saphenous vein segments harvested for
coronary artery bypass
Skin or other normal tissue removed during
cosmetic or reconstructive procedures
(blepharoplasty, cleft palate repair,
abdominoplasty, rhinectomy or syndactyly
repair) that is not contiguous with a lesion and
that is taken from a patient who does not have a
history of malignancy
Teeth without attached soft tissue
Therapeutic radioactive sources
Tonsils and adenoids if clinically not suspicious
Torn menicus
Varicose veins
DISCRETIONARY
GROSS &/OR MICROSCOPIC
(under 10 yrs old)
(over 10 yrs)
Page 23
REMOVAL OF TISSUE, BLOCKS OR SLIDES FROM THE ORIGINAL HOSPITAL SITE

Anatomic Pathologists are charged with the responsibility of keeping and guarding the integrity of the
ever-growing number of tissue containing paraffin blocks and slides derived from surgical, cytological
and autopsy diagnostic services. Documentation and maintenance (tracking) of the continuous care
shall ensure quality practice. These specimens must be maintained in orderly files to ensure ready
access. There are inevitably increasing demands for slides, blocks or tissues to be retrieved from the
original site.
*A release form must be provided and retained on file at the original institution for permanent
release.
Summary
Follow HIPA guidelines
Ensure there is sufficient material for further work-up
Indicate reason for request
Return all material as soon as possible
The lab is the custodian of tissue, blocks or slides collected.
The source of material remains the property of the patient.
These are the various suggested categories to be considered:
In-Province Consultation
Request may be initiated by the primary physician, surgeon or oncologist for review by local or outof-district pathologist.
Request may be initiated by the original signing out pathologist who is responsible for maintaining
records and assuring return of the material.
Note: The return of materials to the original site must be documented and a consult report sent to the
original pathologist as well as the requesting pathologist.
Out-of-Province (recommended slides only)
Request from an originating pathologist to seek out-of-province consultation for diagnostic purpose.
Research or national study groups request specimen be referred to another institution for
treatment.
If blocks are requested, cut a set and send the cut set. The originals should be maintained at the
processing site.
Educational Consultation
Requests for educational rounds should be restricted to slides; to ensure integrity of patient
property.
Request should indicate for rounds and materials returned promptly to ensure ongoing patient
care.
Page 24
Research
Regulations require pathologists to obtain patient authorization and/or an Institutional Review
Board (Ethics Committee) waiver of informed consent when using any identifiable patient health
information for research purposes.
Requests must ensure the integrity of the patient material.
All materials that have critical diagnostic, prognostic or medical-legal implication may be retained at
the discretion of the releasing institution.
Return all materials as soon as possible.
References:
Guardians of the Waxand the Patient. Editorial.; American Journal of Clinical Pathology 1995 104 p 356-7
Use of Human Tissue Blocks for research. Association of Directors of Anatomic and Surgical Pathology. Human
Pathology 1996.27 p 519-520
Page 25
CHEMISTRY
Page 26
ESTIMATED GLOMERULAR FILTRATION RATE - eGFR

The glomerular filtration rate is the estimated volume of glomerular filtrate that moves from renal
glomerular capillaries into the Bowmans capsule per unit time. Evidence-based clinical practice
guidelines suggest that an estimate of GFR (eGFR) provides the best clinical tool to gauge kidney
function. The Canadian Society of Nephrology has recommended that laboratories report eGFR
routinely for adult patients, in order to detect chronic kidney disease.
Serum creatinine results can vary significantly and tend to be ineffective in general practice as an early
marker. 24 hr. collection for creatinine clearance is impractical and prone to error. eGFR should be
reported on outpatients over the age of 18 years. eGFR has not been validated for use in hospitalized
patients and therefore, is not recommended for reporting on inpatients.
eGFR is less reliable in,
patients with near normal eGFR
unstable serum creatinine
acute illness
extremes of body composition (eg. obesity, cachexia)
unusual muscle mass (e.g. marked muscularity, muscle disease, amputation)
pregnancy
age under 18 years or over 70 years
drugs with significant renal toxicity or clearance
drugs affecting creatinine metabolism or clearance
unusual dietary intake (e.g. vegetarians)
other serious comorbid conditions
Summary:
Reporting of eGFR is becoming the standard of care in helping identify stage and monitor patients with
chronic kidney disease.
eGFR > 60
eGFR 30-59
eGFR 15-29
eGFR < 15
Normal or slightly decreased kidney function (stages 1 or 2)

Moderately decreased kidney function (stage 3)
Seriously decreased kidney function (stage 4)
Kidney failure (stage 5)
eGFR is frequently used for DRUG DOSING using the Cockroft-Gault equation. eGFR-MDRD has not
been validated for this purpose.
eGFR-MDRD assumes steady state. For rapidly changing kidney function, monitor serum
creatinine. (MDRD: Modification of Diet in Renal Disease)
The reported eGFR shall be multiplied by 1.21 for patients of African descent.
NOTE: This information is intended for clinicians, patients and allied health professionals.
References: www.jasn.org, www.csnscn.ca, www.renal.org
http://www.kidney.org/professionals/kdoqi/gfr_calculator.cfm
Page 27
CROSSCHECK/VALIDATION GUIDELINE FOR THOSE FACILITIES WITH MULTIPLE CHEMISTRY/HEMATOLOGY INSTRUMENTS PERFORMING THE SAME TEST PROCEDURE
Proficiency testing registration is mandatory for each analytical test.

Rotating proficiency testing result submission between analyzers is not a requirement, but is suggested where appropriate (e.g. Blood Gases).
Where there are multiple analyzers performing the same test procedure in larger facilities, it may be more appropriate for proficiency testing submission
to be consistently submitted from the same analyzer for tracking purposes.
An internal cross-check/validation protocol is required to ensure that there is correlation between all analyzers providing the same test result in the
same facility.
If this protocol is not followed, then each analyzer must be registered in the external proficiency testing program as mandated by LQAP.
This procedure is recommended every six months.
Chemistry/Hematology High Volume Analyzers (e.g. Electrolytes/CBC)
Validation/Crosscheck Element:
Patient correlation
Patient correlation
Frequency/Data Points:
Requirement:
Regularly scheduled intervals

Minimum of 20 patient specimens/2 times per year or
Whenever criteria for recalibration/validation is met:
equivalent
(i.e. 10 patient specimens/4 times per year or on-going data
change of manufacturer for reagents or equivalent
collection as appropriate)
after maintenance or service as per manufacturers
As necessary per recalibration/validation event
recommendations
as required for purposes of troubleshooting
/validation of reagent lot # changes or as indicated
by quality control data
Chemistry/Hematology Low Volume Analyzers (e.g. Fibrinogen)
Requirement:

recommendations
Minimum of 5-10 patient specimens/2 times per year or

equivalent
Page 28
PROCEDURE/METHOD STATISTICAL WORK-UP/VALIDATION STUDY GUIDELINES: CHEMISTRY/HEMATOLOGY

Work-up guidelines and definitions (change in method/instrument):
Work-up
Element
Definition: CLIS or International Federation of Clinical Chemistry

(IFCC)
Minimum Data Requirements (where

appropriate):
1. Imprecision
within run
between run
The variation in analytical results demonstrated when a particular

specimen of aliquot is analyzed multiple times or on multiple days.
Imprecision is expressed quantitatively by a statistic such as
standard deviation or coefficient of variations.
2. Patient
Correlation
The correlation coefficient is a means to look for a relationship, not

agreement, between pairs. Two methods may have a perfect
correlation throughout the measuring range but may not agree in
value (i.e. one may be double the value of the other).
3. Linearity
(IFCC) The range of concentration or other quantity in the specimen

over which the method is applicable without modification (CLIS)
when analytical results are plotted against expected concentrations;
the degree to which the plot curve conforms to a straight line is a
measure of the system linearity.
4. Reference
range
validation
It is common convention to define the reference range or interval of

a laboratory test as the central 95% interval bounded by the 2.5 and
97.5 percentiles of the selected patient population. Validation of an
established reference range requires a minimum of 20 samples.
Closeness of the agreement between the result of a measurement
and the accepted reference value (true value of the analyte)
Within run use preferably a patient

sample or pool close to the decision levels
with a minimum of 10 data points.
Between run 20 results from 20 separate
runs on 2 levels over a 10-day minimum
time period using appropriate QC material.
40 data points are recommended with a
minimum of 20 having 50% of the data
points outside the reference intervals, if
possible. Correlations should involve
comparison with an acceptable reference
method or laboratory.
4 data points each in duplicate as a
minimum requirement, but 5 data points
are preferred (over reportable range).
Linearity studies are expected on an initial
method work-up and further studies as
defined by the College guidelines (i.e.
troubleshooting).
The minimum requirement is 20 data
points for confirmation of an established
reference range and 120 for the
establishment of a new reference range.
3 data points using acceptable reference
material (i.e. CEQAL or CAP) 1 data point
may be acceptable for haematology
accuracy studies if related to sample
stability.
Sensitive studies are only required for
those methods which have clinical
relevance at values close to 0 (i.e. TSH)
Applicability:
Qualitative
5. Accuracy
6. Sensitivity
Measure of the ability of an analytical method to detect small

quantities of the measured component. When concern is
performance at a very low concentration it is useful to determine
the detection limit as influenced by imprecision.
Quantitative
n=20
n=40
When
clinically
relevant
When clinically
relevant
Page 29
7. Specimen
Stability
The conditions of handling and storage, which permits the

measurement and reporting of a clinically relevant result.
8. Interference
The effect of any component of the sample on the accuracy of the

measurement of the desired analyte.
9. Recovery
A recovery procedure involves the addition of a known amount of

analyte to an aliquot of sample. Recovery is defined as the ratio of
the amount of the analyte recovered to amount added and is given
as percentage.
No data generally required. As per

manufacturers guidelines. If
manufacturers stability window is to be
extended a stability study is expected.
Document the manufacturers interference
information. The method should include a
disclaimer or a process for dealing with a
lipemic, icteric or hemolyzed sample.
Recovery studies should only be necessary
for those methods or analytes where
organic extractions or equivalent are
required as part of the methodology (i.e.
Toxicology)
Storage and
transportation
dependent
Methods with
known
interferences
Storage and
transportation
dependent
Methods with
known
interferences
Method
specific/organic
extraction
Work-up requirements when an instrument is moved from site A to site B: (It is assumed that the instrument has been in recent use with acceptable
performance).
Work-up Element
1. Imprecision studies, QC only
2. Patient correlation
Minimum data requirements:

As above
10 data points, where feasible.
Page 30
HEMATOLOGY
Page 31
DIFFERENTIAL PERFORMANCE AND REFERRAL PRACTICE GUIDELINE

Blood Film
Reference Range
WBC Count adults

Lower referral range
Upper referral range
children (2-14 years)
children (90 days 2 yrs)
newborn (0 90 days)
Absolute Neutrophils
Absolute Granulocytes
Absolute Eosinophils
Absolute Basophils
Absolute Lymphs
Adults
children (0-14 years)
Absolute Monocytes
Hemoglobin
adult female
4.0 - 11.0 x 10 /L
adult male
135 180 g/L

adult female
adult male
Pediatric ranges
children (1 mo 14 yrs)
5.0 15.0 x 10 /L
9
5.0 20.0 x 10 /L
9
7.0 20.0 x 10 /L
9
1.5 7.5 x 10 /L
9
1.5 7.5 x 10 /L
9
0.0 0.6 x 10 /L
9
0.0 0.2 x 10 /L
9
1.1 4.4 x 10 /L
Perform a Differential or Scan on

First Occurrence or Significant
Change
9
<1.5 x 10 /L (all age groups)

9
>25.0 x 10 /L
<1.5 x 10 /L
9
<1.5 x 10 /L
9
>1.0 x 10 /L
9
>0.3 x 10 /L
(all age groups)

(all age groups)
(all age groups)
(all age groups)
Referral
Unexpected or Unexplained
9

9
>25.0 x 10 /L

9
9
>2.0 x 10 /L (all age groups)
9
9
>5.0 x 10 /L
9
>7.0 x 10 /L
9
>7.0 x 10 /L
9
>10.0 x 10 /L
9
<100 g/L
(Combined with MCV <70 fL)
<100 g/L
<100 g/L
<100 g/L
120 160 g/L

135 180 g/L
>165 g/L
>185 g/L
>165 g/L
>185 g/L
105 145 g/L
<100 g/L
<135 g/L or >210 g/L
None
<100 g/L
(Combined with MCV <70fL)
<135 g/L or >210 g/L
>0.65 L/L
<70.0 fL or >100.0 fL
(Combined with HGB <100.0 g/L)
<97.0 fL
<70.0 fL
<90.0 fL
>360 g/L
None
None
12
>6.5 x 10 /L
>365 g/L
none
none
12
>6.5 x 10 /L
0.2 0.8 x 10 /L
120 160 g/L
newborn (0 1 month)
HCT
MCV
> 3 months (adult)
135 195 g/L

0.37 0.50 L/L
0 3 months
98.0 114.0 fL
MCHC
MCH
RDW
RBC COUNT
adult female
adult male
310 360 g/L
79.0 97.0 fL
27.0 32.0pg
11.5 14.5 %
12
3.2 5.4 x 10 /L
12
4.6 6.2 x 10 /L
Page 32
Blood Film
MPV
Platelet Count
WBC Morphology
Reference Range
7.4 10.4 fL
Perform a Differential or Scan on

First Occurrence or Significant
Change
None
150 400 x 10 /L
<100 x 10 /L
9
>600 x 10 /L
NUCLEATED RBCS
RBC Morphology
PLATELET MORPHOLOGY
OTHER CRITERIA
Specified Instrument
Flags
Ordered by Physician
Technologist Discretion
Referral
Unexpected or Unexplained
<6.0 fL
>14.0 fL
9
<100 x 10 /L
9
>600 x 10 /L
> 10% Reactive Lymphs
Pelger-Huet anomaly
Hypogranulated neutrophils
Hairy Cells
Blasts/Immature Cells
Hypersegmented neutrophils
>5 NRBC/100 WBC
RBC inclusions: Pappenheimer,
Howell-Jolly or Heinz Body,
basophilic stippling
Presence of schistocytes,
echinocytes, bite cells, sickle cells,
rouleaux, autoagglutination,
significant polychromasia, oval or
round macrocytes, target cells, tear
drops, spherocytes, elliptocytes,
acanthocytes, stomatocytes
Dimorphic picture
Parasites Malaria
none
When indicated
Physician request
Technologist initiated
Physician request
Technologist initiated if suspicious
cells are present, refer to a
pathologist
The Color Atlas of Hematology, Hematology and Clinical Microscopy Resource Committee, CAP; Glassy,
Eric F. is recommended as a resource.
NOTE: This table is provided as a guideline only. Consult a larger centre for more specific ranges.
Page 33
RED BLOOD CELL MORPHOLOGY REPORTING GUIDELINE

Red Blood Cells/100x oif
(200 RBC field) x 10 fields
Abnormality to be Reported
Schistocytes
Any present
Echinocytes/Burr Cells
Bite Cells
Sickle Cells
Basophilic Stippling
Howell Jolly Bodies
Dimorphic
RBC Rouleaux (5cells stacked)
RBC Agglutination
Parasites
Nucleated RBC
>5
Implications for Diagnosis

Thrombotic thrombocytopenic purpura (TTP),
RBC fragmentation syndromes such as
hemolytic uremic syndrome, DIC,
microangiopathic hemolysis, malignant
hypertension, eclampsia, Cardiac valve
hemolysis, some renal vascular diseases
Kidney Disease
Drug or chemical induced oxidative damage,
unstable hemoglobins
Sickle Cell Anemia, Hemoglobin SC/SD Disease
Lead Poisoning, Thalassemia, Sideroblastic &
Megaloblastic Anemia, Sickle Cell Anemia
Megaloblastic Anemia, Post-splenectomy state
Hemorrhage, response to treatment,
Sideroplastic anemia, post-transfusion
Paraproteinemia, increased fibrinogen,
inflammatory disorders
Autoimmune Hemolytic Anemia (Cold
Agglutinin Disease)
Identify specific forms
Severe hemolysis, part of Leukoerythroblastic
picture, Bone marrow stress
Polychromasia
Macrocytes (oval)
Response to treatment, blood loss, Hemolysis

Megaloblastic state, Aplastic Anemia,
Myelodysplastic Syndrome
Target Cells
Liver Disease, Post-splenectomy/hyposplenism,
Hemoglobinopathy, Thalassemia
Tear Drops
Myelofibrosis, Pernicious Anemia
Spherocytes
Hereditary Spherocytosis, Autoimmune
Hemolytic Anemia
Pappenheimer Bodies
Sideroblastic Anemia, Chronic Hemolysis, Liver
Disease
>10
Macrocytes (round)
Liver Disease, Alcoholism
Elliptocytes
Hereditary Elliptocytosis
Acanthocytes/Spur Cells
Post-splenectomy state, Liver Disease,
Abetalipoproteinemia
Stomatocytes
Liver Disease
Microcytes (hypochromic cells)
Iron Deficiency, Thalassemias, Treated
Polycythemia
*Avoid using the terms anisocytosis and/or poikilocytosis since they convey no specific meaning.
The numeric value is meant for internal use to indicate a significant abnormality presence. No
numeric value is reported, just the abnormality.
Page 34
DIFFERENTIAL QUALITY CONTROL

The following is a list of measures undertaken by each laboratory to ensure the quality of differential
results reported on patients.
Good Laboratory Practice:
1. Develop a protocol for determining if a manual differential is required based on instrument
capabilities. (i.e. Hematology GuidelinesDifferential Reporting Guidelines)
2. Develop a list of abnormalities, which must be reviewed by the supervisor or pathologist before
results are reported. Refer to Blood Film Guideline.
3. Differentials must be repeated if each cell does not meet the limits set out in the table below. If the
repeat is still not within the established limits, a second technologist should repeat the differential.
4. Whenever the tech1 has concerns with a differential the rest of the CBC can be released with a
notation Differential to follow. The requesting physician can be invited to review the smear if they
so choose. The smear should be evaluated as soon as possible.
5. Leukocyte abnormalities seen during a smear review require a manual differential completed
regardless of the protocol for when to perform a manual differential.
6. Perform the manual differential and compare it to the automated differential using the 95%
confidence limits table. Each cell should compare within the range set.
7. Differentials between technologists should also fall within the established limits (95% confidence
limits).
8. If the manual differential performed by two technologists agrees within the established limits, but is
not in agreement with the automated differential, then the manual differential should be reported
out instead of the automated differential.
9. It is good laboratory practice to circulate unknown QA slides quarterly. The results will be compared
with peers and should be within the 95% confidence limits as set by the following table. Any
problem areas will be covered between the technologist and the supervisor.
Procedure:
How to use the following 95% confidence limits table:
1. Look up each cell number you want to compare to in column a.
E.g. 25% neutrophils
2. If a 100 cell differential was performed go to the column n=100 to determine the acceptable
range. If a 200 cell differential was done refer to column n=200.
E.g. you counted 32 neutrophils in a 100-cell differential.
1
Tech refers to the medical laboratory technologist or combined laboratory and x-ray technologist.
Page 35
3. Determine acceptability of the differential by checking if the number you counted for a certain cell
falls within the stated range.
E.g. Stated range is 16-35%; you are within this range.
4. Repeat for each cell type.
5. Determine acceptability of each cell line by comparing automated to manual differential. For the
neutrophils/granulocytes, segmented neutrophils, band neutrophils and other neutrophil precursors
must be added together and for lymphocytes, reactive lymphocytes and lymphocytes must be
added together.
E.g. 77 segs and 15 bands = 92%
6. You must be within this range, or the differential must be repeated.
Example:
The automated or technologist differential indicated the following differential and the acceptable range
for each number was looked up in n=100 column:
Neu:
70 acceptable range
60-79
Lymph: 15
8-24
Mono:
7
1-12
Eos:
3
0-9
A 100 cell differential is completed by another technologist and based on the acceptable range the
results are as follows:
Neu: 52 not within limits
Lymph: 27 not within limits
Mono: 12 within limits
Eos: 7 within limits
Baso: 2 within limits
This manual differential would have to be repeated.
Page 36
The 95% confidence limits for various percentages of leukocytes of a given type as determined by
differential counts on stained blood smears.
n
0
1
2
3
4
5
6
7
8
9
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
91
92
93
94
95
96
97
98
99
100
n=100
0-4
0-6
0-8
0-9
1-10
1-12
2-13
2-14
3-16
4-17
4-18
8-24
12-30
16-35
21-40
25-46
30-51
35-56
39-61
44-65
49-70
54-75
60-79
65-84
70-88
76-92
82-96
83-96
84-97
86-98
87-98
88-99
90-99
91-100
92-100
94-100
96-100
n=200
0-2
0-4
0-6
1-7
1-8
2-10
3-11
3-12
4-13
5-14
6-16
10-21
14-27
19-32
23-37
28-43
33-48
37-53
42-58
47-63
52-67
57-72
63-77
68-81
73-86
79-90
84-94
86-95
87-96
88-97
89-97
90-98
92-99
93-98
94-100
96-100
98-100
n=500
0-1
0-3
0-4
1-5
2-7
3-8
4-9
4-10
5-11
6-12
7-13
11-19
16-24
21-30
26-35
30-40
35-45
40-50
45-55
50-60
55-65
60-70
65-74
70-79
76-84
81-89
87-93
88-94
89-95
90-96
91-96
92-97
93-98
95-99
96-100
97-100
99-100
n=1,000
0-1
0-2
1-4
2-5
2-6
3-7
4-8
5-9
6-10
7-11
8-13
12-18
17-23
22-28
27-33
32-39
36-44
41-49
46-54
51-59
56-64
61-68
67-73
72-78
77-83
82-88
87-92
89-93
90-94
91-95
92-96
93-97
94-98
95-98
96-99
98-100
99-100
References:
1. Abbott training seminarthe preceding table was provided.
2. Clinical Hematology Principles, Procedures, Correlations, Cheryl A Lotspeich-Steininger et al, 1992.
3. FHHR protocol
Page 37
SMUDGE CELLS
Distinguished by their naked amorphous nuclear chromatin material, smudge cells were initially
described as white blood cells with broken-down nuclei in patients with chronic lymphocytic leukemia.
Subsequently, these nuclear shadows have most often been referred to as smudge cells, but the term
basket cells is used synonymously.
The mechanism is often associated primarily with traumatic disruption of cells during blood film
preparation. In the process, the cell membrane ruptures and when viewed under a microscope, what
remains looks like a smudge, hence the term, smudge cells.
To ensure reliability of results, it is important to understand the effects of variables associated with
smudge cell formation, particularly the blood film preparation. Thus, the angle and the degree of incline
of the slide spreader, the type of slide spreader (sharp or smooth), the cleanliness of the slides, and the
overall quality of the blood films cannot be overemphasized. For minimal morphologic alterations,
blood films should be made within three hours and not more than twelve hours after collection.
It is recommended to include smudge cells in the differential as an absolute count, especially when the
smudge cell numbers are noticeably increased. This identifies a more appropriate count because
smudge cells are actually lymphocyte artifacts. It also avoids the need for repeating or verifying
abnormal counts by the time - consuming albumin treated method.
Education is needed (for the ordering physicians especially) to eliminate the risk of misinterpreting this
smudge cell count as a new cell type.
Criteria for Reporting Smudge Cells
Absolute lymphocyte count should be greater than 5.0 x109/L.
Patient age should be more than 30 years*.
Smudge cells should be reported if greater than 10 per 100 leukocytes. Report smudge cells in absolute
numbers.
*Although CLL is not often diagnosed in patients under the age of 40, patients over 30 years of age
should be considered potentially at risk. CLL is rare in patients under 30 years of age.
*In children (18 & under), the smudge cells are not counted as part of the differential. However, the
presence of smudge cells may be noted on the report.
*Smudge cells are present in those candidates for which definitive diagnostic criteria are well
established. Examples include: CLL & Acute Leukemia.
Page 38
CROSSCHECK/VALIDATION GUIDELINE FOR THOSE FACILITIES WITH MULTIPLE CHEMISTRY/HEMATOLOGY INSTRUMENTS

PERFORMING THE SAME TEST PROCEDURE
Proficiency testing registration is mandatory for each analytical test.

Rotating proficiency testing result submission between analyzers is not a requirement, but is suggested where appropriate (e.g. Blood Gases).
Where there are multiple analyzers performing the same test procedure in larger facilities, it may be more appropriate for proficiency testing submission
to be consistently submitted from the same analyzer for tracking purposes.
An internal cross-check/validation protocol is required to ensure that there is correlation between all analyzers providing the same test result in the
same facility.
If this protocol is not followed, then each analyzer must be registered in the external proficiency testing program as mandated by LQAP.
This procedure is recommended every six months.
Chemistry/Hematology High Volume Analyzers (e.g. Electrolytes/CBC)
Patient correlation
Patient correlation
Requirement:

Minimum of 20 patient specimens/2 times per year or
equivalent
(i.e. 10 patient specimens/4 times per year or on-going data
collection as appropriate)
recommendations
Chemistry/Hematology Low Volume Analyzers (e.g. Fibrinogen)
Requirement:

recommendations
Minimum of 5-10 patient specimens/2 times per year or

equivalent
Page 39
PROCEDURE/METHOD STATISTICAL WORK-UP/VALIDATION STUDY GUIDELINES: CHEMISTRY/HEMATOLOGY

Work-up guidelines and definitions (change in method/instrument):
Work-up
Element
Definition: CLIS or International Federation of Clinical Chemistry

(IFCC)
Minimum Data Requirements (where

appropriate):
1. Imprecision
within run
between run
The variation in analytical results demonstrated when a particular

specimen of aliquot is analyzed multiple times or on multiple days.
Imprecision is expressed quantitatively by a statistic such as
standard deviation or coefficient of variations.
2. Patient
Correlation
The correlation coefficient is a means to look for a relationship, not

agreement, between pairs. Two methods may have a perfect
correlation throughout the measuring range but may not agree in
value (i.e. one may be double the value of the other).
3. Linearity
(IFCC) The range of concentration or other quantity in the specimen

over which the method is applicable without modification (CLIS)
when analytical results are plotted against expected concentrations;
the degree to which the plot curve conforms to a straight line is a
measure of the system linearity.
4. Reference
range
validation
It is common convention to define the reference range or interval of

a laboratory test as the central 95% interval bounded by the 2.5 and
97.5 percentiles of the selected patient population. Validation of an
established reference range requires a minimum of 20 samples.
Closeness of the agreement between the result of a measurement
and the accepted reference value (true value of the analyte)
Within run use preferably a patient

sample or pool close to the decision levels
with a minimum of 10 data points.
Between run 20 results from 20 separate
runs on 2 levels over a 10-day minimum
time period using appropriate QC material.
40 data points are recommended with a
minimum of 20 having 50% of the data
points outside the reference intervals, if
possible. Correlations should involve
comparison with an acceptable reference
method or laboratory.
4 data points each in duplicate as a
minimum requirement, but 5 data points
are preferred (over reportable range).
Linearity studies are expected on an initial
method work-up and further studies as
defined by the College guidelines (i.e.
troubleshooting).
The minimum requirement is 20 data
points for confirmation of an established
reference range and 120 for the
establishment of a new reference range.
3 data points using acceptable reference
material (i.e. CEQAL or CAP) 1 data point
may be acceptable for haematology
accuracy studies if related to sample
stability.
Sensitive studies are only required for
those methods which have clinical
relevance at values close to 0 (i.e. TSH)
Applicability:
Qualitative
5. Accuracy
6. Sensitivity
7. Specimen
Stability
Measure of the ability of an analytical method to detect small

quantities of the measured component. When concern is
performance at a very low concentration it is useful to determine
the detection limit as influenced by imprecision.
The conditions of handling and storage, which permits the
measurement and reporting of a clinically relevant result.
No data generally required. As per

manufacturers guidelines. If
Quantitative
n=20
n=40
When
clinically
relevant
Storage and
When clinically
relevant
Storage and
Page 40
8. Interference
The effect of any component of the sample on the accuracy of the

measurement of the desired analyte.
9. Recovery
A recovery procedure involves the addition of a known amount of

analyte to an aliquot of sample. Recovery is defined as the ratio of
the amount of the analyte recovered to amount added and is given
as percentage.
manufacturers stability window is to be

extended a stability study is expected.
Document the manufacturers interference
information. The method should include a
disclaimer or a process for dealing with a
lipemic, icteric or hemolyzed sample.
Recovery studies should only be necessary
for those methods or analytes where
organic extractions or equivalent are
required as part of the methodology (i.e.
Toxicology)
transportation
dependent
Methods with
known
interferences
transportation
dependent
Methods with
known
interferences
Method
specific/organic
extraction
Work-up requirements when an instrument is moved from site A to site B: (It is assumed that the instrument has been in recent use with acceptable
performance).
Work-up Element
1. Imprecision studies, QC only
2. Patient correlation
Minimum data requirements:

As above
10 data points, where feasible.
Page 41
PROTOCOL FOR VALIDATION OF LINEARITY ON AUTOMATED HEMATOLOGY ANALYZERS

Purpose:
To validate the entire range through which patient values can be reported or to verify the
manufacturers stated linearity from the analysis of undiluted or diluted specimens for all measured
parameters.
Specimen Selection:
For each parameter requiring linearity validation, choose a specimen with results at/near or above
the high end of the linear range published by the manufacturer of the instrument. Ensure that there
were no interfering substances noted during analysis of the specimen. This value is equivalent to
100% while patients plasma or instrument diluent is equivalent to 0%.
For RBC and HGB use a polycythemic or concentrated sample:

A concentrated specimen may be prepared by centrifuging the specimen and removing plasma to
produce a value near or above the high end of the linear range published by the manufacturer.
Linearity of MCV, MCH and MCHC can also be performed by concentrating the specimen. For RBC
and HGB, do not exceed an HCT of 0.60-0.65.
For WBC use a leukocytosis sample diluted in patients own plasma or instrument diluent.
For PLT count use a thrombocythemic sample diluted in patients own plasma or instrument diluent.
Ensure that sufficient specimen is collected for dilution preparations and instrument aspiration.
Procedure:
1. Verify that instrument reagents are not expired and that sufficient volume of reagents is loaded on
instrument to cycle all the prepared dilutions.
2. Check that background counts, instrument precision and calibration of the instrument are
acceptable before starting procedure.
3. Determine the volume per dilution by calculating the volume required for aspiration on the
instrument. One specimen may not provide sufficient volume. If more than one tube is drawn, pool
the tubes into one aliquot.
4. Label five clean plastic tubes 80%, 60%, 40%, 20% and 0%.
5. Prepare the dilutions using the original specimen as the 100% as shown in table provided below.
Make sure the 100% sample remains well mixed throughout the dilution preparation process.
Page 42
Dilution (%)
100
80
60
40
20
0
Specimen (Parts)
10
8
6
4
2
0
Diluent (Parts)
0
2
4
6
8
10
6. Analyze each well-mixed dilution in triplicate on the instrument. Results with suspect
parameter flags should not be used.
7. Record all results for each parameter from all three runs on table provided.
8. Calculate Obtained Mean value for each parameter.
9. Calculate Expected value for each parameter by multiplying the Reference Mean (100%
Obtained Mean) by the multiplication factor.
10. Calculate the Difference between Obtained Mean and Expected Mean.
11. To graphically illustrate linearity, plot each parameter on linear graph paper with the obtained
mean value for the parameter on the X axis and the expected value for the parameter on the Y
axis. Draw a line through all the points on the graph. When the obtained mean is plotted
against the corresponding expected value, the plotted curve will approximate a straight line for
a linear method. Excel spreadsheet can also be used to show linearity.
Note: Linearity is performed initially and when calibration fails to meet the laboratorys acceptable
limits.
References:
1. Package insert from R&D Systems Inc. which sells a CBC-LINE Full Range Hematology Linearity Kit and CBC-LINE Low Range
Hematology Linearity Kit 1994
2. Shinton NK, England JM, Kennedy DA, Guidelines for the evaluation of instruments used in Haematology laboratories J
Clin Path 1982;35; 1095-1102
3. Package insert from STRECK Calibration Verification Assessment 2007
4. Quam EF, Method Validation The Linearity of Reportable Range Experiment ASCP
Page 43
WBC Linearity
WBC Results
Run #1
Run #2
Run #3
Obtained Mean
Reference Mean
X Multiplication Factor
0%
X 0.0
20%
X 0.2
40%
X 0.4
60%
X 0.6
80%
X 0.8
100%
(Reference)
X 1.0
Expected Value
Difference
Allowable Evaluation Limits
0.4
0.4
0.4
0.4
0.4
0.4
RBC Results
0%
20%
40%
60%
80%
100%
(Reference)
RBC Linearity
Run #1
Run #2
Run #3
Obtained Mean
Reference Mean
X 0.0
X 0.2
X 0.4
X 0.6
X 0.8
X 1.0
Expected Value
Difference
0.1
0.1
0.1
0.1
0.1
0.1
HGB Results
0%
20%
40%
60%
80%
100%
(Reference)
HGB Linearity
Run #1
Run #2
Run #3
Obtained Mean
Reference Mean
Expected Value
Difference
X 0.0
X 0.2
X 0.4
X 0.6
X 0.8
X 1.0
0%
20%
40%
60%
80%
100%
(Reference)
PLT Linearity
PLT Results
Run #1
Run #2
Run #3
Obtained Mean
Reference Mean
X 0.0
Expected Value
Difference
10
X 0.2
X 0.4
X 0.6
10
10
10
X 0.8
10
X 1.0
10
Page 44
PROCEDURE FOR WBC ESTIMATE

WBC Estimation is to be used for cases in which the instrument flags invalid data or suspect WBC
populations and for which you cannot obtain a valid WBC in any mode.
1. Examine the specimen for presence of a clot, strands of fibrin, or gross hemolysis before you
proceed.
2. Next examine the histograms for likely causes of interference. Histogram review may help you
decide which version to use if it is necessary to issue a partial CBC report. (If the HGB or PLT results
are critical or STAT, these should not be held back.) Most interferences are visible in the lower
region of your first WBC histogram, e.g. resistant RBC, NRBC, megathrombocytes, clumped platelets,
fibrin, etc. In some cases, the analyzer will incorrectly include these interferences in the
lymphocytes. This results in both a falsely elevated WBC and lymphocyte count. Rule of thumb: the
lowest WBC from the analyzer is usually the most correct.
3. Make and stain two blood smears.
4. Two techs shall do an estimate, each using a separate slide (if a second tech is not available, one
tech can do two estimates, one on each slide)
a. Examine the smears under 10x objective for even distribution of WBC before proceeding. If
there is a ridge or layer of WBC in the tails, the estimate will be invalid. Re-make the slide.
b. Choose an area from the tails, where the RBC are evenly spread, or just beginning to overlap
(where 50% of the red cells are overlapping doubles or triplets). This should be the same area
where you would do RBC morphology or platelet estimation. Be aware that if the RBC/PCV are
low, you must avoid going in too deep. Then count in ten consecutive fields.
c. Switch to hpf. Count the total number of WBC seen in 20 fields. Include disintegrated cells. Do
not include NRBC.
d. Divide your total by 20 to obtain the average number of WBC/hpf, to two decimal places.
Multiply the average by the conversion factor for the microscope.
Refer to conversion factor procedure for hpf.
Average your result with that of the other tech.
e. If your estimate is 0.40 or lower, just call it less than 0.5
f. If your estimate is over 0.40 calculate the estimate as a range of +/- 40% from this number.
Round off the results of 2.0 or lower to one decimal place; round off results over 2.0 to the
nearest whole number.
Page 45
The examples below are using a microscope conversion factor of 2.5.

Example 1:
Avg. number of WBC/hpf on #1 slide = 1.55 x conversion factor of 2.5 = 3.875
Avg. number of WBC/hpf on #2 slide = 2.00 x conversion factor of 2.5 = 5.00
Average estimate from two slides (3.875+5.00) 2=4.4375
40% Range=4.4375x4.0=1.775
Estimate =4.4375 +/- 1.775, or 2.6625 to 6.2125. Round off to whole numbers.
WBC Estimate is 3 to 6 x 10^9/L
Example 2:
Estimate is calculated as 0.30.
Estimate is 0.40 or lower, so interpret range as less than 0.5
Example 3:
Estimate is calculated as 0.45, range of 0.27 to 0.72.
Round off as 0.3 to 0.7.
Example 4:
Estimate is calculated to be 2.5, range of 1.5 to 3.5.
Round off as 1.5 to 4.
5. If the estimate range agrees with the analyzer WBC, report the best results from the analyzer.
Example:
Analyzer count = 5.5
Estimate from films is 4.4 +/- 40%, or 3 to 6.
Report the analyzer WBC of 5.5.
6. If the WBC estimate does not agree with the analyzer count, report the estimate as a range.
Examples:
WBC estimate on film appears to be less than 0.5 x 10^9/L.
WBC estimate on film appears to be 1.5 to 4 x 10^9/L.
WBC estimate on film appears to be 3 to 6 x 10^9/L.
7. If it is absolutely necessary to report a differential with a WBC estimate, it must be a manual
differential in relative units (%).
References:
nd
Clinical Hematology Principles, Procedures, Correlation, 2 Edition, E. Anne Stiene-Martin et. al: J.B. Lippincott Company, 1998
Page 46
ESTABLISHING CONVERSION FACTOR FOR WBC ESTIMATION

Purpose:
To provide for instruction for establishing a conversion factor for the hematology microscope by
calculating the ratio of electronic count to the number of WBC on either hpf or per oil immersion field.
Frequency:
The conversion factor must be established once for every microscope used in hematology or when there
are major repairs or changes in the analyzer for electronic counts or a new microscope is used for
estimates.
Procedure:
Note: Total leukocyte counts can be estimated roughly either by hpf or 100x oil immersion field.
Therefore 100x oil immersion field can be substituted in procedure that states hpf.
Step:
1.
2.
3.
4.
5.
6.
7.
Action:
Perform electronic WBC count on 30 consecutive fresh patient blood samples. Alternatively if
unable to perform 30 consecutive samples it is acceptable to perform 10 samples per day on 3
consecutive days.
Prepare and stain one peripheral blood film for each sample.
For each film, under hpf microscopy, find an area where 50% of the red cells are overlapping
doubles or triplets. Then count WBC in 10 consecutive fields.
Divide by 10 the total number of WBC found to obtain the average number per hpf.
Divide the electronic WBC count by the average number of WBC per hpf.
Add the numbers obtained in step 5 and divide by 30 (number of observations in this analysis)
hpf.
Round the number calculated in step 6 to the nearest whole number to obtain an estimation
factor.
Reference:
nd
Clinical Hematology Principles, Procedures, Correlation, 2 Edition, E. Anne Stiene-Martin et. al: J.B. Lippincott Company, 1998.
Page 47
WBC Estimation Conversion Factor Log Sheet

Microscope Model: _______________________ ID: ______________________________
Column 1
Column 2
Column 3
Column 4
DIVIDE AUTOMATED
SPECIMEN ID
AUTOMATED WBC
WBC ESTIMATION
WBC COUNT BY WBC
COUNT
ESTIMATION
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
Average Estimation
Factor
__________________
Calculation:
To determine Average, total the values in Column 4, divide by 30. Round off to nearest whole number
to obtain the estimated factor.
Page 48
PROCEDURE FOR PLATELET ESTIMATES

1. Platelet estimation is to be used for cases in which instrument flags identify invalid platelet data,
platelet clumps and for verifying platelet counts below 100x109/L. Scan the slide for clumps under
hpf. If platelet clumps are present, they cause a false decrease in platelet count. Edit out the platelet
count by replacing it with the message Platelets clumped, results invalid. Do not report the MPV.
NOTE: For this purpose, platelet clumping is defined as at least 5 clumps, with at least 5 platelets per
clump. Rare or occasional smaller clumps should be ignored.
2. Switch to 100x objective. Total the number of platelets in at least 10 fields. Determine the average
number per field. Multiply by the conversion factor established for your microscope. The estimate
should agree with the analyzer count +/- 40%
Example:
Average of 6.3 cells per field x conversion factor of 11 = estimate of 69 x 10^9/L.
Analyzer count of 88. Multiply by 0.6 or 1.4 for +/-40% range of 53 to 123.
Platelet estimate agrees with analyzer.
3. If your estimate disagrees with the instrument platelet count by more than 40% in the absence of
clumps:
a. Have another technologist do an estimate, when possible, to confirm the discrepency.
b. If the patient is anemic or polycythemic (RBC below 4.0 or over 6.0), the estimate may be
inaccurate. A second blood film should be prepared, (see Indirect Platelet Count Procedure) and
performed by two technologists, this may require referral.
c. Examine the platelet histograms and the blood smear for the following sources of error:
i) RBC fragments: may be small enough to be counted as platelets.
ii) Megathrombocytes: if many of the platelets on the film appear abnormally large, i.e.
approximately the size of RBC, the analyzer may not be including them in the count. If your
estimate varies from the analyzer by more than 40%, add the message Platelet estimate
appears higher on film; megathrombocytes may be excluded from count. Do not comment
anything if occasional large platelets are present, and your estimate agrees within 40%.
iii) Leukocyte cytoplasmic fragments, if present in large numbers, may falsely elevate the
instrument platelet count. They appear as particles similar in size to platelets, but with a
homogeneous, rather than granular, structure.
4. If you are reporting the platelet estimate instead of the analyzer count, append an appropriate
comment:
Platelet estimate 20 x 10^9/L
Platelet estimate > 20 x 10^9/L
Platelet estimate > 50 x 10^9/L
Platelet estimate >100 x 10^9/L
Note: You should not use this method if RBC is abnormal.
Page 49
5. Send to Senior Technologist/Pathologist for review on first occurrence for each patient for whom
the instrument count is determined to be invalid due to RBC fragments, leukocyte fragments, or
megathrombocytes.
Reference:
nd
Clinical Hematology Principles, Procedures, Correlation, 2 Edition, E. Anne Stiene-Martin et. al: J.B. Lippincott Company, 1998
Page 50
ESTABLISHING CONVERSION FACTOR FOR PLATELET ESTIMATION

Purpose:
To provide instructions for establishing a conversion factor for the hematology microscope by
calculating the ratio of electronic count to the number of platelets per oil immersion field.
Frequency:
The conversion factor must be established once for every microscope used in hematology or when there
are major repairs or changes in the analyzer for electronic counts or a new microscope is used for
estimates.
Procedure:
Step: Action:
1.
Perform electronic platelet count on 30 consecutive fresh patient blood samples. Alternatively if
unable to perform 30 consecutive samples it is acceptable to perform 10 samples per day on 3
consecutive days.
2.
Prepare and stain one peripheral blood film for each sample.
3.
For each film, under oil immersion (100x) microscopy, find an area where 50% of the red cells
are overlapping in doubles or triplets. Then count platelets in 10 consecutive fields.
4.
Divide by 10 the total number of platelets found to obtain the average number per oil immersion
field.
5.
Divide the electronic platelet count by the average number of platelets per oil immersion field.
6.
Add the numbers obtained in step 5 and divide by 30 (number of observations in this analysis) to
obtain the average ratio of the platelet count to platelets per oil immersion field.
7.
Round the number calculated in step 6 to the nearest whole number to obtain an estimation
factor, the number of peripheral blood platelets represented by one platelet in an oil immersion
field.
Reference:
nd
Clinical Hematology Principles, Procedures, Correlation, 2 Edition, E. Anne Stiene-Martin et. al; J.B. Lippincott Company, 1998
Page 51
Platelet Estimation Conversion Factor Log Sheet

Microscope Model: __________________________ ID: __________________________
Column 1
Column 2
Column 3
Column 4
DIVIDE AUTOMATED
AUTOMATED PLATELET
PLATELET COUNT BY
PATIENT ID
COUNT
PLATELET ESTIMATION PLATELET ESTIMATION
1.
2.
3.
4.
5.
6.
7.
8.
9.
10
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
Average Estimation
Factor
__________________
Calculation:
To determine Average, total the values in Column 4, divide by 30. Round off to the nearest whole
number to obtain the estimated factor.
Page 52
INDIRECT PLATELET COUNT

Purpose:
An indirect platelet count may be obtained by determining the ratio of platelets on a blood film to RBC.
The ratio is then used to calculate the number of platelets in comparison to the number of RBC x 1012/L.
This method is useful for situations in which an accurate platelet count cannot be obtained from the CBC
analyzer e.g. samples with marked megathrombocytes, RBC fragments, or leukocyte cytoplasmic
fragments. It is particularly more accurate than conventional estimation when the RBC is abnormal.
Procedure:
1. Make two good quality blood smears. Air dry and stain as for differentials. The peripheral smears
must be well made, not touching edges of slide, with rounded end and no visible tails.
2. Obtain the RBC count from the automated CBC analyzer.
3. Using a 100x oil immersion objective, count the number of platelets per 500 RBC. Two technologists
should count one slide each and the platelets counts should check within 10 platelets of each other.
If the counts do not check, a third technologist counts in the same manner.
4. Add the two agreeable counts together and multiply this result by the RBC count to obtain the
indirect platelet count in 109/L. Next calculate +/- 10 to report the result as a range rather than an
exact number.
Example:
RBC = 4.10
1st count = 11 platelets per 500 RBC
2nd count = 15 platelets per 500 RBC
11+15 = 26
26 x 4.10 = 107
Add and subtract 10 to establish the reportable range.
The indirect platelet count is reported as 97 to 117 x 109/L.
5. Compare the indirect platelet count to the analyzer count. If the indirect count is within the
analyzer count +/- 30%, report the analyzer count.
6. If the indirect count is not within the analyzer count +/- 30%, report the indirect platelet count.
Procedure Notes:
The Indirect Platelet Count is preferable to platelet estimation when an accurate platelet count cannot
be obtained on the CBC analyzer. It is particularly more accurate than conventional estimation when
the RBC is abnormal.
Limitations of the Procedure:
The indirect method is not recommended as the method of choice for enumerating platelets. However,
it is useful when an accurate platelet count cannot be obtained by the CBC analyzer.
Page 53
References:
1. Raphael SS. Lynchs Medical Laboratory Technology, Third Edition, Philadelphia PA: WB Saunders Company, 1976, page 1084.
2. Hematology Laboratory Safety Manual, Royal University Hospital, Saskatoon, SK 1998
3. Constantino BT. Leukocyte Cytoplasmic Fragmentation: Its Causes and Laboratory Evaluation, Canadian Journal or Medical
Laboratory Science -60, 1998, page 195
Page 54
INTERNATIONAL SENSITIVITY INDEX (ISI) VERIFICATION
Purpose:
Verification of ISI is mandated for all laboratories using assigned instrument-specific ISIs. Verification
must be performed in each laboratory at least annually, to ensure the accuracy of the International
Normalized Ratio (INR) result. Verification is done using a set of certified plasmas.
NOTE: This guideline does not apply to point-of-care/rapid cartridge-based technology, at this time.
Frequency:
Verification of ISI is required:
when a new instrument is put into place;
with any change in reagent type;
with any change in reagent lot number;
with any change in instrument;
following instrument repair, if QC is outside acceptable limits;
at a minimum of once per year.
Procedure:
1. Determine Geometric Mean Normal Prothrombin Time (MNPT) for current lot. [*contact LQAP office
for Geometric Mean Calculator]
2. Obtain a set of certified plasmas from the manufacturer. A minimum of three certified plasmas with
an INR range of 1.5 - 4.5 are recommended. The certified plasma must be appropriate for the
instrument in which they will be used.
3. Perform INR test on certified plasma in duplicate over three sessions.
4. Determine mean INR from the three sessions of testing on all certified plasmas.
a) If the mean INR is within 15% of assigned INR on all certified plasmas then the ISI is valid and
verification is complete.
b) If the mean INR is not within 15% of assigned INR revalidate the MNPT.
i. If MNPT is valid, then a local system calibration must occur; go to step 5.
ii. If MNPT is not valid, then it must be re-established, go back to step 1.
5. Contact the manufacturer for further instructions (ie. calibration). Return to step 3.
Page 55
VERIFYING OR ESTABLISHING A NORMAL REFERENCE RANGE FOR ROUTINE COAGULATION TESTING

Purpose:
To provide instructions for establishing or verifying a Normal Reference Range for routine coagulation
testing.
1. Verifying a Normal Reference Range: To verify a normal reference range, 20 representative
donor samples should be used.
2. Establishing a Normal Reference Range: For an assay that has never previously had a reference
range study, 120 donor samples should be used.
To provide instructions for lot number changes of reagent or quality control (QC) material.
Frequency:
Verify a Normal Reference Range:
With any change in reagent lot number

Following instrument repair if QC is outside acceptable limits
At a minimum of once per year
Establish a Normal Reference Range:
When a new instrument-reagent system is put into place

With any change in instrument
With any change in reagent type
Sample Information:
Specimens must be the same type and collected in the same container required for a given test (usually
3.2% citrated plasma; see specific procedure).
Accumulate the appropriate number of normal donors that meet the following guidelines:
1. Healthy with no known pathological conditions (in-patients should be avoided they are
hospitalized for a medical reason).
2. On no medications affecting coagulation, including anticoagulants/blood thinners.
3. Span the adult age range (unless a pediatric range is required).
4. Equally divided between males and females. If unable to maintain equal male/female ratio, a
larger center may be able to assist with donor specimens.
Donor samples can be collected in advance to speed up the evaluation process. The samples should be
double spun, aliquoted and stored for up to 14 days at -20 C or up to 6 months at -80 C. Spun plasma
should have <10x109/L platelet counts.
Page 56
Procedure for Verifying a Normal Reference Range

Prompt
Run the applicable tests(s) as per
procedure manual.
Print all results.
Run applicable QC for each
assay.
Additional Information
Examine all results for outliers. Repeat outliers to rule out an
analyzer error.
When determining new reference ranges, it is acceptable to
exclude outlier values particularly any values that fall
outside the current normal range - providing a minimal
number of data points are involved.
An assay with more than 5% unexplained outliers should be
discussed with the laboratory supervisor.
Calculate the geometric mean Compare reference range with previous range and submit to
and SD from the data (Refer to the lab supervisor for review before implementing.
the
Geometric
Mean
Calculation).
Establish a
reference range based on the
mean 2 SD.
Procedure for Establishing a Normal Reference Range

Consultation with Laboratory Manager/Director (or a coagulation specialist) is recommended when
establishing a normal reference range.
Sequestering Reagents/Quality Control Materials
1. All routine coagulation reagents (Prothrombin Time, APTT and Fibrinogen) and related QC
materials should be sequestered from the supplier in appropriate volumes for long term use
(usually up to 1 year).
2. When sequestering new lot items, be sure to ask for an expiry date longer than the time
sequestered for.
3. When sequestering a new lot of PT reagent, always check the ISI assigned to your specific
instrument. An ISI close to 1.0 is preferable and improves correlation between instruments and
peer laboratories.
4. Be sure to allow adequate time for shipping and preliminary testing prior to depleting your
current stock.
Lot Number Changes:
Note: It is not recommended to change reagent and QC lots for the same assay, at the same time.
1. Reagent Lot Number Changes
a. Establish a new mean and 2 SD normal range for the applicable assay as described in the
procedure above.
b. Compare the new reference range with the previous. Variation should be minimal. If there is a
significant fluctuation (> 5%), consult with supervisor to obtain new lot number of reagent.
Page 57
c. Establish new mean and SD for all QC levels associated with the assay using the new lot number
of reagent (see below - Quality Control Lot Number Changes).
Note: If possible, run the new lot of reagent in parallel with your current lot whenever QC is run.
When performing parallel testing with new lots of reagent, it is not recommended to load any new
patient samples on the analyzer this will prevent possible release of erroneous results.
2. Quality Control Lot Number Changes
a. Establish a new mean and 2 SD reference range for each level of control using a minimum of 20
data points. Run the new control in parallel with the current control whenever QC is required.
Note: Running all QC points consecutively is not recommended as this will not reflect changes in the
age of reagents or controls, and may result in a reference range that is too narrow. Run QC on
multiple days and multiple shifts.
b. Compare the SD and mean of your current QC lot to that of the new lot. Generally there should
not be any significant fluctuations. Ensure the CV is acceptable (5% or less).
NOTES:
Fibrinogen
If the reagent being changed is for the fibrinogen assay, a new standard calibration curve must be
performed before any preliminary testing proceeds. Compare old and new curves there should not be
a significant change between the lot numbers.
APTT
If the laboratory performs APTTs on heparinized patients, a Heparin Therapeutic Range for APTT must
be done using the same unfractionated heparin used for patients.
Prothrombin Time
1. If the analyzer requires a PT Calibration when changing reagent lot number, this must be
performed before any other testing.
2. Before implementing the new lot number of reagent, ensure that the new ISI and Mean Normal PT
(MNPT) are entered in the appropriate areas of the analyzer and/or LIS (depending on how the INRs
are calculated).
3. When doing the patient correlations (old vs. new lot of reagent) enter the new ISI and MNPT into
the analyzer/LIS to enable comparison of INRs, instead of PTs (Prothrombin Times may not
compare well if the ISI value has changed significantly).
Reference: Adapted from the Regina QuAppelle Health Region
Page 58
FLUID REVIEW BY PATHOLOGIST

All differential fluid preparations should be processed according to CLSI guidelines. Wedge smears
should not be used with fluids because of their inferior ability in preserving intact cells. Cytocentrifuge
preparation is recommended for air-dried body fluid slides as this concentrates the cells, minimizes cell
distortion and produces a single layer of cells. This process provides excellent morphologic detail.
Additionally, it is in the best interest of patients that all fluid differentials be referred to a pathologist for
review. If your facility does not have a pathologist on site, they may be referred to another centre for
review.
References:
H56-A CLSI, Body Fluid Analysis for Cellular Composition; Approved Guideline 2006
CAP Hematology and Coagulation Checklist, 2014
Body Fluids American Society of Clinical Pathologists; Authors Carl Kjeldsberg and Joseph A. Knight, 1993
Page 59
MANUAL ESR QC PROCEDURE
ESR racks are controlled on a monthly basis.
Laboratories using one rack - 2 fresh samples are set up in duplicate using different rack positions.
Laboratories using more than one rack - 2 fresh samples are set up in each rack using alternating
rack positions each month.
Set up the samples immediately after thorough mixing is completed. The samples must be remixed
between each rack set up.
Record appropriate results, rack #, position # and initials on the monthly QC sheet.
Results below 20 mm/hr should check within 20%, results over 20 mm/hr should check within 10%.
If results are not within acceptable limits, sample will be repeated if quantity is sufficient or a new
sample is chosen. If results still exceed limits, notify supervisor.
Reference:
Laboratory Services Regina QuAppelle Health Region
Page 60

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Laboratory Quality Assurance Program

College of Physicians & Surgeons of Saskatchewan

LABORATORY GUIDELINES 2016

The following GUIDELINES have been revised, added, or deleted:

Specimens Exempt From All Gross &/or Microscopic Pathology Laboratories

Differential Performance and Referral Practice Guidelines

Reference Textbook List for Laboratories

Performance of Whole Blood Glucose Testing

Fluid Review by Pathologist

International Sensitivity Index (ISI) Verification

Reference Textbook List

Laboratory Guidelines 2016 Edition

Surgical Pathology Reports

Erythrocyte Sedimentation Rate (ESR)

Performance of Whole Blood Glucose Testing

Laboratory Guidelines 2016 Edition

Specimens Exempt from all Gross &/or Microscopic Pathology Laboratories

Estimated Glomerular Filtration Rate eGFR

Differential Performance and Referral Practice Guideline

Laboratory Guidelines 2016 Edition

Laboratory Guidelines 2016 Edition

References include: CSTM, CSCC, CAP, CSA, ISO, CPSS

Laboratory Guidelines 2016 Edition

Quality Control (QC)

Life of the instrument, plus 2 years

Laboratory Guidelines 2016 Edition

Life of the instrument, plus 2

Manifests must be retained for a minimum of 1 year

Urine Smear for

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RECOMMENDED RESOURCES FOR LABORATORIES

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CENTRIFUGE OPERATING SPEEDS

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DUTIES OF MEDICAL LABORATORY ASSISTANT (MLA) OR LAB ASSISTANT (LA)

Laboratory Guidelines 2016 Edition

HIV POCT QUALITY CONTROL

For new INSTI user verification

Laboratory Guidelines 2016 Edition

Laboratory Guidelines 2016 Edition

QUALITY CONTROL (QC)

Prior to reporting patient results

Laboratory Guidelines 2016 Edition

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VISUAL COLOR DISCRIMINATION

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SPECIMENS EXEMPT FROM ALL GROSS &/OR MICROSCOPIC PATHOLOGY LABORATORIES

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GROSS &/OR MICROSCOPIC

(By Chemistry Dept.)

Laboratory Guidelines 2016 Edition

GROSS &/OR MICROSCOPIC

(under 10 yrs old)

REMOVAL OF TISSUE, BLOCKS OR SLIDES FROM THE ORIGINAL HOSPITAL SITE

Laboratory Guidelines 2016 Edition

Laboratory Guidelines 2016 Edition

Laboratory Guidelines 2016 Edition

ESTIMATED GLOMERULAR FILTRATION RATE - eGFR