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Lab General

Dr. Ruba Y. Abed


Consultant Hematopathologist/ Clinical Pathologist
Head, Hematology & Coagulation Department
MedLabs Consultancy Group, Amman/Jordan

https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.clinicallab.com
Course Outline
• Module 1:
Introduction to Clinical/ Medical Laboratory and the three Phases of Workflow

• Module 2:
Pre-Analytical Phase

• Module 3:
Analytical Phase

• Module 4:
Post Analytical phase
• General introduction to Clinical/ Medical Laboratory

• Types of Clinical laboratories

• Sections of Clinical Laboratory

• Different tests done at each lab section

• General & Special requirements of tests


Introduction

• This is a simple introduction to the general workflow in the


clinical/ medical laboratory.

• The clinical laboratory is responsible for analyzing patient


specimens, in order to provide information pertaining to the
diagnosis, treatment, and prevention of disease, in addition to
evaluation of the effectiveness of therapy.
Introduction
• There are a variety of Clinical Laboratory settings

• Mainly two types:

o Hospital labs
o Non-Hospital Labs;
 Stand Alone Labs
 Reference Labs

• All Clinical laboratories must be regulated by Legal entities; e.g. MOH


Introduction
• Laboratory Personnel;

oLab Director
oSupervisory Staff
oTesting Personnel
Clinical Laboratory Structure,

Work Area
Waiting Area
Phlebotomy Room
https://nursekey.com/patient-reception-and-processing-2/
Patient Reception https://www.bfwh.nhs.uk/our-services/pathology/departments/phlebotomy-outpatients

https://www.istockphoto.com/photos/hospital-reception
The Clinical Laboratory in a Hospital Setting

• The clinical laboratory in a hospital runs tests on patients that pertain to the
diagnosis, prevention and treatment of diseases.

• Although the laboratory is within the hospital, it generally does other testing aside
from tests conducted for the hospital.

• Other clinics, private practice doctors and


medical facilities will send their clinical
specimens to hospitals for analysis.
https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.hfmmagazine.com%2Farticles%2F1703-designing-clinical-labs
Sections of the Clinical Laboratory
• Phlebotomy (blood collection)

•Specimen Processing: The area of the laboratory where all incoming specimens
are;

oSorted,
oAccessioned into the computer system of the laboratory,
oAppropriately labeled for transport to their respective departments for testing or
transport to reference labs.
Lab sections
Clinical Chemistry
• The Clinical Chemistry Laboratory is a state-of-the-art, fully automated laboratory.
• Tests performed on plasma, serum, urine and other body fluids such as CSF, synovial
• Or peritoneal fluids.

• Tests include but are not limited to sugar, lipid profile, kidney function tests and liver blood tests.

https://diagnostics.roche.com/

• Clinical Chemistry includes STAT and routine testing in the areas of general chemistry, endocrinology, special chemistry,
immunology and toxicology.
Lab sections
Clinical Chemistry

• The chemistry section performs analyses on blood, urine, cerebrospinal fluid


(CSF), and other fluids to determine how much of various clinically
important substances they contain.

• Most applications of electronic instrumentation in the clinical laboratory take


place in the chemistry section.
https://diagnostics.roche.com/
Biochemistry Analyzers

• The biochemistry analyzer is a machine that uses the photoelectric colorimetric


principle to measure a specific chemical composition in body fluids.

• The biochemistry analyzer is widely used in hospitals, epidemic prevention


stations and family planning service stations at all levels because of its high
speed, accuracy and small amount of reagents consumed
Semi automated analyzers
• Semi auto analyzer means that some of the operations in the analysis process (such as adding
samples, holding, inhalation colorimetry, result recording and other certain steps) need to be done
manually.

• The semi auto analyzer is characterized by its small size, simple structure and flexibility, and can be
used separately.

• At the same time, semi-automatic biochemical analyzers can be used in conjunction with other
medical equipment.

• Most importantly, semi-automatic biochemistry analyzers are very inexpensive


https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.biobase.cc%2FSemi-auto-Chemistry-Analyzer
Fully automated biochemistry analyzer

• The fully automated biochemistry analyzer is fully automated from sample


addition to result generation.

• The operator only needs to put the sample on the specific position of the
analyzer and choose the program to start the instrument to take the test
report.

https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.skalar.com
Lab sections
Clinical Immunology
• The Immunology Laboratory is responsible for tests that helps in the
evaluation of autoimmune disease, immunodeficiencies,
immunoproliferative disorders, and allergy.

https://www.istockphoto.com/photos/immunology

• It also has responsibility for some aspects of infectious disease serology.


Lab sections
Hematology
• Hematology is the study of blood and blood disorders.

• The Clinical Hematology Laboratory performs a wide variety of basic and advanced hematology
testing.

o Routine hematology testing including complete blood count, blood differential, smear morphology
and bone marrow staining.

o Routine coagulation testing (PT and PTT).


Stago. Us https://medschool.co/tests/blood-film
https://www.sysmex.com/US/
Lab sections
Special Hematology
• Specialized hematology testing including manual procedures like Osmotic fragility testing, LE cells,
Hams Test, Hemoparasites.

• Flow cytometry testing for lymphomas, leukemias, plasma cell neoplasms, etc..
https://www.youtube.com/watch?v=JRGqAavekiU

• Hemoglobin Pattern Analysis.

https://www.bdbiosciences.com/en-us/products/instruments/flow-cytometers/clinical-cell-analyzers/facscanto

• Advanced coagulation testing including hypercoagulability studies, coagulation factor and inhibitor
studies, platelet antibody and aggregation, antiphospholipid antibody testing, and others.
Lab sections
Microbiology
The Clinical Microbiology Laboratory offers diagnostic bacteriology, mycology, parasitology,
virology, and mycobacteriology.

• The microbiology section performs studies on various body tissues and fluids to determine
whether pathological microorganisms are present.

https://www.rch.org.au/specimen-collection/Blood_Culture/

• Until quite recently, there were essentially no applications of electronic instrumentation in


microbiology.

• However, devices that automatically monitor the status of blood cultures are now being
used in many microbiology laboratories. https://www.researchgate.net/publication/306018042_Microbiology_Laboratory_Manual
Lab sections
Routine
• A frequently performed test that gives a general indication of the patient’s overall state
of health and more specifically the urinary tract.

https://www.youtube.com/watch?v=H2rb3pKJHWg

https://www.news-medical.net/health/Urine-Analysis-Urinalysis.aspx

• It is important to examine fresh specimens, otherwise cells and casts may disintegrate or
distort with bacterial infections.
Lab sections
Genetics
• The Division of Laboratory Genetics actively contributes to the study of genetic
disease and the advancement of genetic testing and related technology, with a goal of
enhancing clinical patient care.

o The Cytogenetics Laboratory provides comprehensive services in all types of


chromosome studies.

o The Molecular Genetics Laboratory provides expertise in DNA and molecular genetic
testing for congenital disorders, infectious disorders and hematology/oncology.
https://biology.wustl.edu/explore-academics/molecular-genetics-genomics
Lab sections
Histopathology
• This section is related to the study of tissues.

• Specimens received by the pathology laboratory require tissue


preparation then are treated and analyzed using techniques appropriate
to the type of tissue and the investigation required.
https://www.news-medical.net/life-sciences/Artificial-Intelligence-in-Histopathology.aspx

• For immediate diagnosis during a surgical procedure a frozen section is


performed.
Point of Care Testing
• POCT brings the laboratory to the patients, also called bed-side
testing.
• Use small simple analyzers
• Portable instruments
• Hb, Glucose, Electrolytes https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.clearstate.com%2Fthe-future-of-point-of-care-testing-in-asia-pacific

https://www.google.com/url?sa=i&url=https%3A%2F%2Fdiagnostics.roche.com%2Fglobal%2Fen%2Fproducts%2Fproduct-category%2Fpoint-of-care-testing.
https://www.labmanager.com/laboratory-technology/managing-workflow-5185

• The workflow of the laboratory is complex with many safety checks


along the way.

• Laboratories should be under strict guidelines from national and state


inspection bodies to ensure that patient safety is never compromised.
https://www.labmanager.com/laboratory-technology/managing-workflow-5185

• A laboratory workflow is a set of procedural rules used to manage and


coordinate tasks between people and systems in the lab.

• Lab workflows for sample management ensure that all steps and
requirements in a defined process are correctly implemented.
https://www.labmanager.com/laboratory-technology/managing-workflow-5185

The work flow is divided into 3 phases so as to match the path a


patient specimen takes as it moves through the laboratory;

• specimen receiving (pre-analytic),


• testing (analytic), and
• result reporting (post-analytic) phases.

https://cmpt.ca/extending-the-scope-of-eqa-to-the-extra-analytical-phases/
https://cmpt.ca/extending-the-scope-of-eqa-to-the-extra-analytical-phases/
• Definition of Pre-analytical phase of Clinical Laboratory Workflow

• Procedure of Patient Reception

• Knowing different types of lab specimens

• Procedure of Phlebotomy for Adults & Newborns

• Complications of phlebotomy and procedures to avoid these adverse reactions


Pre-analytic phase
• The pre-analytic phase is the most vulnerable part of the total testing
process and is considered to be among the most significant challenges to
the laboratory professionals.

• Errors can occur at the time of patient assessment, test order entry,
request completion, patient identification, specimen collection, specimen
transport, or specimen receipt in the laboratory.
Pre-analytic phase
Concerning the preanalytical phase, laboratories should:

• have written procedures for the preanalytical phase


• provide documentation of personnel qualifications and training
• monitor sample quality indicators
Pre-analytic phase
• While management of specimens and policies external to the
laboratory are not fully standardized, protocols for sample
collection, transportation and handling should be available.

• Preanalytical errors can also be avoided by automating support and


administrative operations and enhancing the communication
between the laboratory and healthcare providers
Pre-analytic phase, Patient Reception
• MT will greet the patient and request full information in order to ensure correct
patient and specimen identification at the point of collection.

• Patient name: At least three parts


• According to local regulations and Institute policy.
e.g. For Jordanian patients, request their national ID number and enter it into their file
on LIS system. For non-Jordanian patients enter any available formal identification
numbers, for example: passport number, residency number...etc. For newborns enter
one of the parents ID number through birthdate option.
Pre-analytic phase, Patient Reception
e.g. A copy of patient ID must be attached on LIS system for certain tests including: pre-
marital, beta-HCG, seminal fluid analysis, drugs of abuse, HIV, and as directed by the
lab director.

• Sex and date of birth.

• Patient phone number/ e-mail : patient should insure that his/her phone number is
entered correctly through signing on the disclaimer on the request form to receive
his/her results via SMS or WhatsApp as well as the e-mail for online results.
Pre-analytic phase, Patient Reception

• Patient preparation according to the tests requested,

(e.g. fasting and after meal, fasting and after glucose load, before and after urea
capsule for urea breath test...etc.).

• For other samples that do not require phlebotomy, full instructions should be
either given to the patient for proper collection or the patient will be asked to
read them carefully inside the bathroom (e.g.: urine collection instructions).
Pre-analytic phase, Patient Reception

• For samples received from home or from physician clinics, sample


requirement should be met, otherwise sample should be rejected.

• Source of sample should be written on patient request form and on


patient result report whenever sample is collected from outside the lab.
Pre-analytic phase, Patient Reception
• e.g.
• PAP smear:
oLabel all smears received with patient name (preferably with pencil).

oMake sure to write the following information along with the original
information requirements:
• Patient’s age.
• Last Menstrual Period (LMP) date.
• Number of childbirths & abortions.
• Hormonal replacement therapy, if any.
• Fix the slide with 96% ethanol.
Types of Lab specimens

• Blood specimens
• Body fluids
• Swab specimens for culture
• PAP smear
• Histopathology tissue, fluids & FNA samples
Phlebotomy
Materials required for phlebotomy include;
• Needles: Any of the following needles can be used:

Butterfly; G23- ¾ inches.


2 CC; G23- 1 inches
5 CC; G23- 1¼ inches.
10 CC; G21- 1½ inches.
Vacutainer; (green) G21-1½ inches.
Vacutainer; (black) G22-1½ inches
https://www.shutterstock.com/search/phlebotomy
Phlebotomy
Materials required for phlebotomy include;
• Blood collection tubes.
• Patient barcodes.
• 70 % alcohol wet swabs.
• Dry swabs.
• Tourniquet.
• First aid plaster.
• Personal protective equipment
(e.g. a pair of well-fitting gloves,
lab coat, and surgical/special mask as needed).
• Iodine for blood culture.
https://www.pinterest.com/pin/323696291937241282/
Phlebotomy
Materials required for phlebotomy include;

• Always make sure that the amount of blood you withdraw is relevant to
the tests required and sufficient for a back-up sample,

• Single tests do not require large amounts of blood as these excess amounts
need to be treated with care and caution when disposing for being
considered as hazardous materials.

• Specimen volume should always be taken into consideration to patient age,


health and clinical condition in regard to the number of tests requested.
Phlebotomy
Materials required for phlebotomy include;

• No food, liquid or gum should be in patient’s mouth, especially children, at the


time of specimen collection.

• Do not draw blood from an arm that contains a fistula used for dialysis
patients.

• Some tests require special precautions during sample collection.; Always refere
to established procedures and text books if necessary.
Blood Collection for Adults

• Welcome the patient and explain the process of phlebotomy shortly.


https://www.barkerdentalcare.co.uk/new-patients/

• Double check patient name by asking his/her name, and compare it with
barcodes.

• Follow applied procedures for proper patient identification.

• Apply gloves (face protection if required). https://omnigloves.com/2019/06/07/wearing-disposable-gloves/


Blood Collection for Adults
• Try to relieve the stress by assuring the patient that the process will be short and
he/she should relax until the end of the process.

• Ensure that the patient is in a comfortable position (seated well on the


phlebotomy chair).
https://www.hnl.com/patients/selfpaylabtest

• Apply a tourniquet (5-6 centimeters above the chosen site) and tighten slowly.
• Do not leave on for longer than one minute.

https://www.freepik.com/premium-photo/laboratory-assistant-preparing-patient-blood-analysis-
nurse-tightening-medical-tourniquet-arm-before-taking-blood-sample-concept-healthcare-
Blood Collection for Adults
• Ask the patient to open/close his/her fist then keep it closed.
• Palpate the site, mainly the median cubital vein, to check for rebound elasticity,
press lightly with two fingers and release, then choose the appropriate vein.

https://internationalbiosafety.org/wp-content/uploads/2019/08/How-to-Safely-Collect-Blood-Samples-Ebola.pdf

https://www.healthline.com/health/how-blood-is-drawn

• Disinfect the site using alcohol wet swab (preferably 70% isopropyl or ethyl
alcohol) in a circular motion starting from the center of the venipuncture site
and moving outwards to cover an area of 2 cm or more.
https://www.freepik.com/premium-photo/phlebotomist-disinfect-blood-collection-area-by-alcohol-pad-hospital-sample-
collection_26180787.htm
Blood Collection for Adults
• Place the used alcohol swab in the regular waste bin.

• Allow the site to air dry, do not re-palpate the site.

• For Blood Culture test, sterilize the venipuncture site with Povidone Iodine 10% as well as
the blood culture bottle lid for a minimum of 15 seconds and allow to air dry.

• Attach the venipuncture needle to a syringe or to the vacutainer holder.


https://pdihc.com/wp-content/uploads/2019/04/PDI-Prevantics-Blood-Culture-Info-Sheet_03190579.pdf

• Using your non-dominant hand to achieve skin traction, hold the syringe between your thumb
and index finger.
Blood Collection for Adults
• Position the needle, facing bevel upwards. Insert the needle directly above the vein, through
the skin (angle 10-30°).

https://www.youtube.com/watch?v=7NSEFVbzTAU

• Care should be taken not to enter too fast and too deep otherwise the needle can go
through the back of the vein

• When using the syringe, pull the plunger back slowly until the blood body is filled.

• When multiple blood tests are required, ensure the blood tests are taken in the proper
order of draw as follow:
Phlebotomy order of Draw

https://www.pinterest.com/jop0197/phlebotomy-order-of-draw/
Blood Collection for Adults
• If no blood can be obtained, remove the blood tube (if vacutainer system is
used), loose the tourniquet, apply dry swab over the puncture site and remove the
needle.

• Place the syringe needle in the sharps box and place the syringe body in
biohazard waste bin.

• Maintain the pressure using the dry swab, put the plaster.

• For the second attempt, seek further help from a more experienced person.
Blood Collection for Adults
• Through the blood collection procedure, always observe the patient for
signs of paresthesia, fainting or dizziness.

• For a second attempt, repeat the steps above and collect blood.

• After blood collection, loosen and release the tourniquet. Invert the
bottles gently. Do not shake the bottles.
Blood Collection for Adults

Use the following diagram for blood inversion and the order of
blood draw diagram for the number of inversions for each tube.
Blood Collection for Adults
• Apply dry swab over the puncture site and remove the needle.

• Place the blood syringe needle into the sharps box.

• Maintain a slight pressure on the puncture site to prevent blood leakage. Arm can be elevated
while applying pressure to prevent hematoma formation but do not bend the arm.

• Discard the blood contaminated gauze in the biohazard waste bin. Apply plaster over the
puncture site.

• As soon as possible, set the blood upright in a test tube rack.

• Label the tubes collected with patient barcodes, which should include at least 2 identifiers.
Blood Collection for Adults
• Remove the gloves and place them in the biohazard waste bin.

• Ask the patient about the experience and if he is feeling well before standing up and leaving the
phlebotomy room.

• Join the patient when leaving out of the phlebotomy room and wish him to get will soon.

• MT initial should be written on the request form on (sample drawn by) space.

• In rare cases where the barcodes are not generated before sample collection (for a
justifiable reason), samples must be labelled with at least two identifiers; patient name and
date of birth. Samples must be tracked with MT initials.
Children and Neonates Phlebotomy Procedure
• Ask the children father or mother to sit on the phlebotomy chair and tightly hold the
child.

• Make sure that the children sit in suitable position and ask for another MT to hold the
child’s arm.

• Withdraw the blood using the same procedure for adults’ blood withdrawal

• If the baby is less than 6 months, put the baby on baby’s bed and ask for help from
another MT to hold his/her arm.

• Withdraw the blood using the same procedure for adults’ blood withdrawal.
Neonatal screen Phlebotomy procedure
• Gently massage baby’s heel to increase blood flow.
https://www.hurleymc.com/files/laboratory/capillary-microphlebotomy-collection-technique.pdf

• Sterilize baby’s heel using alcohol swab and let it air dry.

• Using a sterile lancet, puncture the lateral to midline surface


of baby’s heel.
Blood collection, Important Notes
• All sharps used; needles, lancets should be disposed in the sharp
box.

• All other waste should be disposed of


as per waste management plan. https://www.made-in-china.com/showroom/kangyuan01/product-detailYXGQZEmvuPpU/China-Medical-Use-
Sharps-Disposal-Box-Sharp-Container-Square-1L.html

https://www.alibaba.com/product-detail/Red-and-Yellow-plastic-bags-for_62022409400.html
Troubleshooting Guidelines
If an incomplete collection or no blood is obtained

Change the position of the needle. Move it


forward (it may not be in the lumen of the
vein).
Troubleshooting Guidelines
If an incomplete collection or no blood is obtained

OR move it backward (it may have


penetrated too far).
Troubleshooting Guidelines
If an incomplete collection or no blood is obtained

Adjust the angle (the bevel may be against


the wall of vein)
Troubleshooting Guidelines
If an incomplete collection or no blood is obtained

• Loosen the tourniquet. It may be obstructing blood flow.

• Try another tube. There may be no vacuum in the one being used.

• Re-anchor the vein. Veins sometimes roll away from the point of
the needle and puncture site.
Troubleshooting Guidelines
If blood stops flowing into the tube
• The vein may have collapsed; re-secure the
tourniquet to increase venous filling.
• If this is not successful, remove the needle, take
care of the puncture site, and redraw.
• The needle may have pulled out of the vein when switching
tubes.
• Hold equipment firmly and place fingers against patient's
arm, using the flange for leverage when withdrawing and
inserting tubes.
Patient Problems/ Adverse Reactions
Hematoma

Hematoma is a free blood in the tissue that


results in swelling which resembles a bruise. A
hematoma is often accompanied by damage to the
vein preventing further venipuncture.

https://www.healthline.com/health/what-is-a-contusion
To prevent hematoma when
collecting a blood specimen
• Remove the tourniquet before removing the needle.

• Use the major veins if possible (i.e. median cubital or cephalic veins, basilic vein,
not superficial veins). Hand veins are very prone to the formation of hematoma.

• Puncture only the uppermost wall of the vein. Going completely through the
vein may allow blood to leak out through the back wall of the vein into the
tissues.
To prevent hematoma when
collecting a blood specimen
• Make sure the needle fully penetrates the uppermost wall of the vein. Blood may leak
out around the bevel if the needle is not fully inserted into the vein.

• Apply pressure to the venipuncture site with gauze and have the patient elevate his/her
arm.

• If the patient is on anticoagulant therapy, apply a pressure bandage and caution the
patient to leave it on for at least 15 minutes.

• If a hematoma formed under the skin adjacent to the puncture site, release the
tourniquet immediately and withdraw the needle and apply firm pressure.
Patient Problems/ Adverse Reactions
Fainting
• Fainting tends to occur in normal individuals during emotional
stress or during pain, fever, prolonged bed rest, poor physical
condition, anemia, organic heart disease and fasting are all
conditions which may increase patient’s susceptibility to fainting.

• Physiologically, fainting results when the blood supply to the brain


is decreased.
To prevent Fainting when collecting
a blood specimen

• Never draw blood from a patient who is standing. In this position, the patient is
more likely to faint and injure him/ herself as a result.

• If using a phlebotomy chair with a protective arm, keep it closed for support of
the patient in case he/she faints and slumps forward.

• If the patient is sitting in a chair without a protective arm, stay directly in front
of the chair so one can catch the patient if he/she faints and slumps forward.
Patient Problems/ Adverse Reactions
Nausea & Vomiting

Nausea and vomiting may accompany fainting, but more commonly


are associated with other disorders, i.e. chronic ingestion, acute
systematic infections, CNS disorders, endocrine disorders and a side
effect of many drugs and chemicals.
How to deal with Nausea & Vomiting

• Nausea
Make the patient comfortable.
Instruct the patient to breath, deeply and slowly.
Apply a cold towel to patient’s forehead and back of the neck.

• Vomiting
Give the patient an emesis bag and have tissues ready.
Give the patient water to rinse out his/her mouth upon request.
Patient Problems/ Adverse Reactions
Convulsions or Seizures
• Convulsions or seizures are involuntary muscular contractions of varying
degrees.

• They may be localized to one part of the body or generalized, involving


both sides of the face, arms, legs, and trunk.

• They are the result of abnormal electrical impulses occurring within the
brain. This causes a loss of consciousness and convulsive movement.
How to deal with Convulsions or Seizures
• Do not attempt to restrain the movements of the patient.

• Move surrounding objects that might cause injury to the patient.

• Loosen any constrictive clothing.

• Be sure the patient has an adequate airway.

• Shield the patient from onlookers to protect him/her from embarrassment.

• In case of epileptic seizures, try to keep patient’s mouth open or hold the tongue, this is done to
prevent the patient from biting/swallowing his/her tongue.
Patient Problems/ Adverse Reactions
Accidental Arterial Puncture

Accidental arterial punctures can lead to


dangerous circumstances for patients if
not cared for properly, including
hematoma.
How to deal with
accidental arterial puncture
• If an arterial puncture is suspected (bright red blood) discontinue phlebotomy
immediately.

• Apply firm pressure to the venipuncture site for a minimum of 10 minutes. Do not even
look under gauze until ten minutes have passed.

• Inquire if the patient is taking anticoagulant therapy.

• If bleeding has ceased after this time period apply a band aid, and instruct the patient not
to perform any strenuous activity (i.e. physical activity or picking children).
Specimen Rejection Criteria include but not limited to;

• Incorrect patient identification.


• Specimens improperly labeled, unlabeled, or with specimen-label
discrepancies.
• Quantity not sufficient (QNS) for proper performance of requested
test.
• Specimens with request forms improperly filled out.
• Hemolysed or clotted specimens.
• Wrong collection tube.
Specimen Rejection Criteria include but not limited to;
• Pap smears that have not been air-dried prior to transport.
• Specimens improperly fixed.
• Unacceptable packaging of the specimen.
• Broken slides (fragmented beyond repair).
• Specimen leakage from container.
• Grossly contaminated specimens.
• Culture swabs that have been allowed to air dry out or have not been
submitted within 24 hours of specimen collection.
• Definition of Analytical phase of Clinical Laboratory Workflow

• Processing of specimens

• Instrument Maintenance

• Quality Control, General Principles

• Calibration, General Principles

• Trouble Shooting, General Principles


Analytic phase
• The analytic phase begins when the patient specimen is prepared for testing and ends when
the test result is interpreted and verified.

• Advances in analytical techniques, laboratory instrumentation, and automation have


improved analytical phase resulting in a significant quality decrease in error rates.

• Nonetheless, analytical quality is still a significant issue. Improper sample preparation or


the presence of interfering substances (e.g., hemolysis, lipids) can affect test results.

• Establishing and verifying test method performance specifications as to test accuracy,


precision, sensitivity, specificity, and linearity are a hedge against unrecognized analytical
errors.
Analytic phase
Concerning the analytical phase, laboratories need to:

• establish and maintain written policy, process, and procedure manuals.


• provide training and perform competency evaluations of personnel.
• participate in a proficiency testing program appropriate for their test menu and
specialties.
• verify Instrument performance and track instrument calibration and
maintenance.
• maintain records of the laboratory environment (e.g., temperature, humidity,
refrigeration).
General laboratory Equipment,
• Autoclave: uses steam under pressure to sterilize contaminated
material before disposal
https://www.medicalexpo.com/prod/bioevopeak

• Laboratory balances: Used to measure chemicals

https://radwag.com/en/as-110-r2-plus-analytical-balance
Other Laboratory Equipment
• Refrigerators
• Freezers
laboratory-refrigerator-labex-468
https://www.labmanager.com/product-focus/how-to-ensure-proper-maintenance-of-refrigerators-and-freezers-

• Water baths
• PH meter https://www.munroscientific.co.uk/the-complete-guide-to-working-in-a-laboratory-water-bath

• Incubators https://www.amazon.com/Fristaden-Lab-Benchtop-Scientific-Electrode/dp/B089LKXS65

• Thermometers
https://www.indiamart.com/proddetail/mercury-red-alcohol-filled-glass-thermometers-22605982012.html
https://www.carolina.com/incubators-and-ovens/incubator-lab-07-cubic-ft-capacity/701296.pr
Other Laboratory Equipment
• Microscope:
o A delicate & expensive instrument,
o Special care must be taken in its use
o Various types
https://www.microscope.com/motic-ba310bp-binocular-polarizing-compound-microscope.html

o Light microscopes:
 Bright field
 Phase contrast
 Fluorescence

o Electron microscope
Analytic phase, Specimen Preparation for Testing:

• Centrifuges
https://www.youtube.com/watch?v=0JcvGsGrWqs

• Secondary test tubes


• Pipettes
• Specimen racks
https://www.qsiquartz.com/6-types-of-tubes-used-in-science-laboratories/

https://www.medicalexpo.com/prod/deltalab/product-68179-865180.html
Instrumentation
*Processing
• Plain tubes: Wait 20 to 30 minutes to assure complete clotting, centrifuge at 4500 rpm
for 10 minutes.

Note: Centrifugation must be completed within the above specified time taking in
consideration the special test requirement and patient history.

• EDTA tubes: Blood samples in EDTA tubes are whole blood samples that are not
centrifuged but used for whole blood tests such as CBC, HbA1C and others.

• Plasma from EDTA and Heparin tubes: centrifuge the tube at 4500 rpm for 10
minutes.
• Always refer to Lab Ps&Ps and or kit inserts for specific tests
Instrumentation
*Processing
Specimen Aliquoting:
• For proper aliquots and to ensure traceability, a barcode pre-labeled tube with patient name and
specimen number and type are placed in a separate rack and the supernatant of the original
centrifuged tube is transferred by a pipette to the pre-identified plastic tube.

• Write your initials on the aliquoted tubes and double check patient name, visit number, and sample
type with the original tube.

• Make sure not to aliquot more than one patient specimen at the same time.
Instrumentation
*Maintenance
Various procedures and routines will ensure that your laboratory equipment is
well-maintained and cared for, this includes;

• Developing standard operating procedures for all lab equipment.


• Preparing documentation on each specific equipment, outlining the repairs and
maintenance undertaken.
• Outlining a preventive maintenance program for each piece of equipment.
• Training both technical and managerial staff on proper use and care of lab
equipment.
Instrumentation
*Maintenance
• Standard operating procedures (SOPs) are a must for all complex lab equipment.
This ensures that the correct use and maintenance of the equipment are
integrated into routine work.

• Detailed instructions for equipment use should be sourced from the


manufacturer’s operator manual.

• The SOP can be written by the lab manager, an equipment officer, or staff that
frequently works with the specific equipment.

• The SOP should also be easily accessible on the workbench.


Instrumentation
*Quality Control
• Controls must be run with every analytical procedure and whenever practically possible.

• At least two levels of controls must be run with each batch of patient samples or per shift and/ or as per the
kit/ instrument/ manufacturer’s recommendations.

• All control runs must be filed in the appropriate control file for review/ documentation.

• Patient results must not be reported unless the appropriate quality controls defined for the procedure are run
and are found to be within acceptable range.
Instrumentation
*Quality Control

• All unacceptable control runs must be recorded on Controls falling outside acceptable limit
log sheet for tracking and appropriate follow up.

• Daily- all QC results must be reviewed by the technologist with regular review by the area
senior/ supervisor/lab director to determine if they meet the acceptability criteria.

• Section Heads/ Directors or designees must review all control data at least on monthly
basis.
Instrumentation
*Calibration
• Calibration is usually the responsibility of the biomedical engineer rather than the
technologists.

• Calibration involves comparing the measurements of equipment against the standard


unit of measure, for the purpose of verifying its accuracy and making necessary
adjustments.

https://www.indiamart.com/proddetail/laboratory-equipment-calibration-services-17864741855.html

• Regular calibration of laboratory equipment should be done because over time, biases
develop in relation to the standard unit of measure.
Instrumentation
*Troubleshooting

• For lab personnel, the ability to troubleshoot their instruments is a valuable


skill to develop.

• This skill allows you to be an independent and responsible personnel.


Instrumentation
*Troubleshooting
Some common steps for troubleshooting problems in the lab are

1. Identify the problem


2. List all possible explanations
3. Collect the data
4. Eliminate some possible explanations
5. Check with experimentation
6. Identify the cause
• Definition of Post-analytical phase of Clinical Laboratory Workflow

• Result Reporting

• Abnormal results & Confirmation

• Critical Results & Notification

• Waste Management
Post-analytic phase
• In the post-analytic phase, results are reviewed and released to the clinician, who
interprets them and makes diagnostic and therapeutic decisions.

• Timeliness and the incorrect interpretation of diagnostic or laboratory tests


were responsible for a significant percentage of errors in ambulatory and
emergency department settings.

• The significant contributions to errors in the post-analytic phase are a failure in


reporting, erroneous validation of analytical data, and incorrect data entry.
Post-analytic phase
Concerning the post analytical phase, laboratories need to:

• report STAT results and critical values promptly and have a written quality
assurance program.
• generate Levy-Jennings or trend plots of QC results to identify changes in test
performance.
• accurately transmit test results.
• reduce human error through root-cause analysis, process control, and
education/communication.
Result Reporting

• Depending on lab internal workflow, result entry section will receive worksheets with the
results of the requested tests signed from the medical technologist who performed the
testing.

• Results will be automatically transferred from the machine to the LIS system (interface),
except for certain calculated and manual tests.

• MT will check results on the LIS system for any mistakes, confirmation, calculation, and
manual tests entry.

• Results will be released and submitted for review & finalization by the lab Director.
Result Reporting
The final result report must include the following elements as applicable:
• Name and address of testing laboratory.
• Patient name and identification number.
• Name of physician or referring source.
• Date and time of specimen collection.
• Date and time of results reporting.
• Specimen source.
• Test results with units, reference intervals based on age and gender.
• Name and signature of Laboratory director.
• Any condition of specimen that may effect the test result or adequacy of
testing.
Result Reporting
• Results reviewed by the lab Director must insure that all unusual or
unexpected results are investigated and confirmed before reporting.

• The review will ensure that the results are matched clinically with patient age,
sex, and history of any previous results on patient’s file.

• The review will ensure that all quality control, quality assurance steps have
been done according to established policies including the handling of any
abnormal or critical results.
Result Reporting

• In the event that a result is found to be erroneous (i.e. due to analytical,


clerical error etc), a correction of the result is done and documented in a
timely manner.

• In the event where the results are delayed for any reason, patient must be
communicated and informed.
Communication of critical results

• Critical result: An abnormal test result that is considered vital to


immediate patient care, diagnosis or management.

• A list shall be determined including any determined by the MoH.

• The result should be communicated immediately to the ordering


physician and/ or assigned personnel.
Communication of critical results
• All verbal communication of results shall be documented including
the read back policy.

• The read back policy requires that the patient receiving the critical
result repeats it back to ensure that the communicated result has
been received accurately by the receiving party.
Communication of critical results
The documentation shall include:

• Name of the reporting personnel


• Name of the notified personnel.
• Date & Time of notification.
• Confirmed test result.
• Result read back.
Result Interpretation &
Clinical Correlation

• Interpretation of a laboratory result requires that the result can be


related to a relevant reference value.

• This can be the same patient's earlier results, if this is possible, or


be done by comparing to data from a "normal" population
Result Interpretation &
Clinical Correlation
• The laboratory result must be interpreted on the background of a reference interval
that is used to distinguish between "health" and "disease".

• The clinician must also evaluate the result from the knowledge of biological
variation and be aware of the potential risk of false interpretation.

• Likewise, influence of random errors and systematic errors on the result is of


importance as well as the diagnostic sensitivity and specificity.
Waste Disposal &
Local regulations

All used tubes, expired tubes, used needles, gloves and other types of
phlebotomy wastes should be disposed of properly and according to
the standards in waste disposal procedure .

https://www.asterhospitals.in/bio-medical-waste-report https://celitron.com/en/medical-sharps-waste-disposal-iss
‫‪MOH Regulations/ Waste Disposal‬‬

‫دليل منع العدوى و السيطرة عليها في مؤسسات الرعاية الصحية‬

‫‪https://moh.gov.jo/‬‬
Waste Disposal &
Local Regulations
Waste Disposal &
Local Regulations

https://www.medlabsgroup.com
Waste Disposable&
Local Regulations
All bags or containers must be:

• Tightly sealed
• Compatible with their components
• Filled to a safe level
• Labeled with lab Name, Weight & Date
Thank You
rabed@medlabsgroup.com

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