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Primary Sample Collection Document ID GD/PSCM

Manual Effective Date 01/10/2021

Department General Review Period 1 Year


Supersedes Issue no: 3
Prepared by Reviewed & approved Issued by
by
Signature

Name Dr. Shrimant Dr. Anju Dhar Mr. Anshouman Roy


Designation TM Head of Lab operations Quality Manager
& Consultant
Microbiologist
Date 16.09.2021 25.09.2021 30.09.2021
Copy No Issued To Date of issue

1 Quality Manager 01-10-2021

Review Record

Sr.no Date Reason for review Reviewed by Sign of Reviewer Valid till

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Doc. No: GD/PSCM Primary Sample Collection Manual
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Amendment Sheet

Page Clause Sign


Sr. No no no Date of Amendment Amendment Reason (consultant) Sign (LD)

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GENERAL DIAGNOSTICS INTERNATIONAL (P) Ltd. Pvt Ltd

Primary Sample Collection Manual

Doc. No: GD/PSCM

Copy Holder: Quality Manager

Issued Under the Authority of

Dr. Pramod Ingale


Lab. Director

GENERAL DIAGNOSTICS INTERNATIONAL (P) Ltd. Pvt Ltd,


RPT House, 2nd floor, Plot No. 6, Sector No. 24,
Turbhe, Navi-Mumbai-400705
Phone: 02261980000
Fax: 0222783840
email: info@gd-lab.com

Website: www.GD-Lab.com

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SECTION 1: Release Authorization

This Primary sample collection manual is released under the authority of Dr. Pramod Ingale, Lab
Director and is the property of GENERAL DIAGNOSTICS INTERNATIONAL (P) Ltd. Pvt Ltd , RPT House, 2nd
floor, Plot No. 6, Sector No. 24, Turbhe, Navi Mumbai-400705.

Dr. Pramod Ingle

Lab Director

GENERAL DIAGNOSTICS
INTERNATIONAL (P) Ltd. Pvt Ltd

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SECTION: 2

Distribution list

Quality Manager in responsible to maintain the controlled copies in editable word format & read only PDF
format in his computer which is password protected.

Read only pdf copy is available on share folder of NABL documents on the laboratory computer to which
access is given to all staff right from accession to lab director.

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SECTION 3: TABLE OF CONTENTS

Sr. Contents Page No.


No.

1 Introduction 7
1.1 Purpose 7
1.2 Lab location 7
1.3 Working hours 7
1.4 Types of clinical services offered 7
2.0 Instructions for sample collection 8
2.1 Sample collection Procedure of blood & Urine for routine 8
tests
2.2 Specific test-based guidelines 11
2.3 Sample collection Procedure for Molecular testing 13
2.4 Sample collection Procedure for Microbiology samples 25
2.5 Sample collection Procedure for Newborn screening 38
3.0 Instructions for completion of the request form 42
4.0 Instructions for obtaining consent 44
5.0 Instructions for sample transport 45
6.0 Sample reception 46
7.0 Sample storage /retention 47
8.0 Disposal of samples 48
Annexure 1 49

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1. Introduction

1.1. Purpose

GENERAL DIAGNOSTICS INTERNATIONAL (P) Ltd. is a referral laboratory. The purpose of this manual
is to provide the information and instructions to paramedics/ nurses to collect, manage & handle
patient test samples for the purpose of examination.

This manual is intended as a reference guide to ensure proper sample collection which is an
essential prerequisite for a good quality report.

1.2. Lab location


GENERAL DIAGNOSTICS INTERNATIONAL (P) Ltd. is located on the ground floor and second floor of
RPT house in
Turbhe, Navi Mumbai. It can be reached via service road off Sion Panvel highway. Access to the
Laboratory is strictly controlled.

Postal address Contact number

GENERAL DIAGNOSTICS INTERNATIONAL 022-40450000


(P) Ltd.
RPT House, Plot No.6, Sector-24

Turbhe, Navi Mumbai,


Maharashtra.
email: info@gd-lab.com

Website: www.GD-Lab.com

1.3. Working hours:

The laboratory is operational 24 hours a day and 7 days a week.

1.4. Types of clinical services offered:

Lab offers extreme test menu from following disciplines:

a) Clinical Biochemistry & Biochemical genetics

b) Hematology

c) Clinical Pathology
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d) Microbiology & Infectious disease serology

e) Molecular Testing

Directory of services is available which states the details like test name, its code, cost of the
test, TAT and the type of sample required. All tests under NABL scope are performed in the
laboratory.

2. Instructions for sample collection:

2.1. Sample collection procedure of blood & urine for routine tests:

For Blood

Materials required
70% alcohol swab
Cotton wool balls or gauze swabs
Disposable gloves
Tourniquet
Marking pen
Bar code
Evacuated tubes for collection
Butterfly winged collection set 9 for difficult veins for pediatric patients
Blood collection needle
Tube holder
Puncture proof container for discarding the needles

Pre- Collection Process

• Identify the patient by checking the test requisition forms. Do NOT draw any specimens
without properly identifying the patient and ensuring tubes are labeled correctly.

• Introduce yourself and explain the procedure in brief to the patient.

• Confirm that the fasting order has been followed if a fasting specimen is required.

• Reassure the patient and position him/her properly for easy, comfortable phlebotomy.

• Assemble equipment and supplies, including vacutainers and other blood tubes, alcohol
swabs, sterile gauze or cotton ball, tourniquet, syringes, needles and needle holders.

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Collection Process

A. General Guidelines:

 All samples must be treated as potentially infectious material and sample must be
withdrawn following aseptic condition.
 Only sterile material should be used for blood collection.
 Venous blood withdrawal should be carried out on the appropriate parts of the elbow bend,
the forearm, or the back of the hand.
 Blood must be withdrawn in recommended standard specimen collection tube.
 Tubes should be mixed by gentle inversions as per the recommendations given in the table
below.
 Do not transfer specimen from one evacuated tube to another.
 Follow proper order of draw.

B. Venepuncture procedure:

• Ask the patient first to make the veins more palpable. Select suitable vein for puncture.
• Veins of the antecubital fossa (median cubital and cephalic veins) are preferred.
• Swab the puncture site with70% isopropyl alcohol. Allow the area to air-dry.
• Apply to tourniquet several inches above the puncture site. Never leave it in place for >1minute.
• Perform the venipuncture. The needle should enter the skin at a~15oangle with the level of the
needle up.
• Release the tourniquet when the blood begins to flow.
• After sufficient blood has been drawn, have the patient relax his/her fist. Do NOT allow the patient
to pump the hand.
• Place a clean sterile cotton ball/gauze over the site. With draw the needle, and then apply pressure
to the site. Place a plaster over the venipuncture wound.

C. Order of Draw:

In case multiple tests are required for the same patient, the order of draw should be as

follows:
• Kindly refer to the given table to identify the correct tube in which the sample is to be sent,
and number of times the tubes have to be inverted for adequate mixing of specimen with
anticoagulent.

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Sr no Cap color Additive Tests Mix by
Inverting
1 Yellow bottle Blood culture bottle Blood Culture 8-10 times

1. Blue Sodium Citrate Coagulation studies, D- 3-4 times


dimer, fibrinogen, INR

2. Red Clot activator silicon Serology and routine 5 times


coated biochemistry

3. Yellow Clot activator & Gel for Serology and routine 5 times
serum preparation biochemistry

4. Green Lithium Heparin STAT Biochemistry 5 Times

5. Lavender K2 EDTA Spray Coated Complete blood count, 8-10 times

HbA1C and Hemoglobin


variants, flow cytometry,
G6PD, HCV RNA PCR

6. Grey Sodium fluoride/ blood glucose analysis 8-10 times


Potassium oxalate

For Urine


Urine samples are to be collected in sterile wide mouthed containers.
• If a delay in sample transportation is expected store the samples at 2-8 degree Celsius till
the time of transport.
Proper collection and preservation of urine are necessary to ensure valid results.

Mainly two types are urine specimen are received in the laboratory:

1. Routine Urine Specimen

2. 24 Hour Urine Specimen

Routine Urine Specimens


Mid-stream urine (5ml) collected into a sterile container is required. Never submit specimens
collected from a bedpan or urinal. The urine collection procedure must be explained to the patient
in detail as below.

Female Patients

• Clean the urethral opening and vaginal vestibule prior to collection.


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• Disinfectants are not recommended for cleaning. Soaps will be enough.

• Dry after cleaning.

• Patient should wash hands and dry.

• Hold labia apart during voiding of urine.

• Collect only mid-stream urine.

Male Patients

• Wash hands and dry.

• Clean penis, retract the foreskin for uncircumcised patients, wash with soapy water and
then dry.

• Keep foreskin retracted and collect mid-stream urine.

24 Hour Urine Collection


Verbally instruct the patient on how to obtain the 24hour urine specimen. Please stress to patient
the importance of proper urine collection. Ask the patient to repeat the instructions to
determine he/she has understood the following steps:

• Discard the first morning urine. The 24-hour collection begins after this void.

• Record the date and time on the provided urine container

• Collect all urine for the next 24 hours.

• When there is a need to defecate, the bladder should be emptied first to avoid any urine
loss and fecal contamination of the urine.

• The next morning, at the same time recorded on the container, void urine into the bottle.
This is the final urine collection for the 24-hour period.

• Send the urine specimen to the laboratory as soon as possible.

2.2. Specific test-based collection guidelines:

a. Blood Glucose

• Random Glucose: - Sample collected at any time of day


• Fasting plasma glucose: Sample collected after overnight fasting (12 Hr. after food) Also
termed as post Absorptive state. .
• Post prandial plasma Glucose: Sample collected 2 Hr. after a regular meal.

I. Oral Glucose Tolerance Test: (O.G.T.T.)


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a. First Specimen must be collected after overnight fast termed as “0” hour sample.

b. For adults administer 75 grams of anhydrous (82.5gm of glucose monohydrous) in 250-300


ml of water.

For children’s dose is adjusted as 1.75gm/kg body weight of glucose. Ask patient to drink
slowly (within about 5 min) to prevent vomiting.

c. Collect sample after 2 hours post glucose load.

d. If classical OGTT is advised then collect “0” Hour sample & 5 additional sample after every
30 minutes. The total six samples at ½, 1,1 ½ , 2 & 2 ½ hours needs to be collected.

Note: It is advised to collect urine sample with every sample of blood sugar estimation
interval of OGTT.

Lipid Profile
Fasting period of minimum 12 hours is required.

b. Cortisol:

Sample to be collected between 8 am to 8 pm.

c. β-HCG/ FSH / LH / Prolactin test – Date of LMP is required.

d. For Prenatal screening: Following information required.

(a) Patient’s date of birth

(b) Date of LMP

(c) Patient’s weight

(d) Latest USG report (Within last 1 week)

e. Coagulation tests:

For certain coagulation and factor assays tests, the patient should not be under therapy with the
following anticoagulant medication:
• Anticoagulants: Heparin/Warfarin/Coumadin

• Direct thrombin inhibitor: Pradaxa (dabigatran), Acova (argatroban)

• Direct Xa inhibitor: Xarelto (rivaroxaban), Eliquis (apixaban)

f. Semen analysis

Following points must be consider & record before collection.

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(a) Has this test been done before?

(b) If yes, what was the sperm count and sperm motility?

(c) If no, has the patient read and understand the instructions?

(d) Is period of abstinence minimum 3 days?

(e) What is the method of specimen collection?

2.2. SAMPLE COLLECTION FOR MOLECULAR TESTING:

2.2.1 HCV RNA PCR-TEST, HIV RNA PCR-TEST & HBV DNA PCR-TEST :

SAMPLE REQUIRED--EDTA (WHOLE BLOOD)


 Separate plasma from whole blood within 24 hrs hours of collection.

 Centrifuge plasma for 10 minutes at 3000 rpm, room temperature. Using a sterile pippete,
transfer 3-4 ml of plasma to one labelled sterile aliquot tube.

SPECIFIC REJECTION CRITERIAS

 EDTA sample received after 24 hours after collection.

 Leakage.

 Hemolyzed sample

 Lipemic sample

 TRF not available

 Unlabeled sample

SPECIFIC ACCEPTENCE CRITERIA-

 Aseptically collected fresh serum/plasma/sample that is

 Clear

 Non hemolyzed

 Non lipemic

SAMPLE STORAGE-

 Sample should be processed within 8 hours of collection and it can be kept at room temperature.

 Delay in processing more the 8 hours -Refrigerate at 2-8⁰C.

 For 7 Days-2-8⁰C.

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 For 1 month--20⁰C and more then 1 month it can be stored at -80⁰C.

2.3. COVID 19 RNA RT PCR ASSAY-

SAMPLE REQUIRED-Nasopharyngeal swab/oropharyngeal swab in VIRAL TRANSPORT MEDIA

A)MATERIALS REQUIRED-

 N95 Masks

 PPE kits

 Nitrite gloves

 Alcohol based hand sanitizer (70%)

 Alcohol swabs

 1% hypochlorite solution

 Sample vials and VTM(viral transport media),

 Absorbent material (cotton, tissue paper)

 Paraffin

 Cello tape

 Scissor

 Leak proof container (ziplock pouch, cryobox,50 ml centrifuge tube and plastic container.

Thermacolbox/Ice boxes/Vaccine carrier, Cellotape, Biohazard yellow bags, Hard frozen Gel Packs and
Marking pens.

B) Before collection guidelines

All Universal Biosafety Precautions should be followed throughout the procedure of sample collection.

Wear PPE (Personal Protective Equipment) like Apron, Hand gloves, N95 Mask, goggles, face shield and
boots /shoe cover) as per the donning & doffing procedures given below.

Ask the person to sit comfortably and also ask his/her name and age. Explain procedure to the patient.

PROCEDURE FOR DONNING AND DOFFING-

PERFORM HAND HYGIENE BEFORE DONNING WITH SOAP AND WATER

 Wet your hands thoroughly and apply enough soap to cover all surfaces of hands and also each
finger. Rub both hands together ensuring that whole of the palm should be covered.
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 Now place the left hand over the right hand and interlace your fingers and rub them together. clean
between your fingers in all cracks. Clean right between your fingers in all the cracks and cervices,
and up and down the inside of your fingers.

 Clean back of your hands. Place right hand over the back of left hand and repeat again once more
this procedure.

 Now reverse and do the insides of your hands. Place your palms together, interlace your fingers and
clean both your palms and between your fingers from the inside.

 Lock both hands together, using your fingers to ensure your palms are opposite to each other.
Clean the ends of your fingers and nails really well.

 Now Grasp your thumb with forefingers of the opposite hand and clean it in a twisting motion, then
do the same on the other hand. Clean all surfaces of your thumb down to including your wrist.

 Now wash in a circular manner with clasped fingers into the palm of your hand. Make sure you do
this with both hands. Washed hands should be actively rinsed by rubbing the hands together under
tepid or cool running water. When no residual foam is visible the hands are sufficiently rinsed.

 Don’t touch the tap itself with your hands as this can cross contaminate.

 Dry your hands with a single use paper towel.

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DONNING

A) Preparation of donning

 Procedure must be carried out exclusively in clean room identified for donning procedure. No
exposed skin or hair of the laboratory personnel should be visible at the conclusion of the donning
process.
 The laboratory personnel must have adequate liquid or drinks in order to avoid interruption of
sample collection due to thirst or dehydration. PPE requires a tight fitting therefore; one may lose
fluid due to perspiration and as a result dehydration may occur.
 Remove Personal Clothing and Items and Change into surgical scrubs (or disposable garments). No
personal items (e.g., jewellery, watches, cell phones, pagers, pens) should be brought into patient
room.
 Visually inspect the PPE to be worn to ensure it is in serviceable condition, all required PPE and
supplies are available, and that the sizes selected are correct for the laboratory personnel.

B)Donning procedure
 Perform hand hygiene with hand sanitizer and allow hands to dry before moving to next
step.
 Wear on first pair of inner gloves.
 Put on Apron/gown. Ensure it is large enough to allow unrestricted freedom of movement. Ensure
cuffs of inner gloves are tucked under the sleeve of the gown or coverall to prevent skin from
getting exposed.
 Put on Shoe Covers.
 Put on N95 mask. Complete a user seal check.
 Put on full-body disposable apron to provide additional protection to the front of the body against
exposure to body fluids or excrement from the patient.
 Put on second pair of gloves (with extended cuffs). Ensure the cuffs are pulled over the sleeves of
the gown or coverall.
 Put-on full-face shield over the N95 mask to provide additional protection to the front and sides of
the face, including skin and eyes.
 The laboratory personnel should be comfortable and able to extend the arms bend at the waist and
go through a range of motions to ensure there is enough range of movement while all areas of the
body remain covered.
 Disinfect outer-gloved hands with alchol rub and allow drying prior to sample collection or sample
processing.

DOFFING
A) Preparing for Doffing
The doffing process is sequence of the procedure that the PPE has been removed properly. Prior to doffing
PPE, must remind laboratory personnel to avoid reflexive actions that may put them at risk, such as
touching their face.

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B)Doffing procedure
 Inspect the PPE to assess for visible contamination, cuts or tears before starting to remove. If any
PPE is visibly contaminated, then disinfect with 70% ethanol.
 Disinfect and Remove Outer Gloves without contaminating the inner gloves
 Inspect inner gloves for any visible contamination (Note: Change Inner Gloves in case if there are
visible tears and wears. Remove and discard gloves taking care not to contaminate bare hands
during removal process and don a new pair of gloves)
 Remove the apron away from the body taking care not to contaminate the Apron/Gown. Roll the
apron inside out and discard safely in the bio-hazard box.
 Disinfect the inner gloves with 70% ethanol and inspect PPE for any visible contamination.
 Remove the full-face shield by tilting the head slightly forward, grabbing the rear strap and pulling it
over the head, gently allowing the face shield to fall forward and discard. Avoid touching the front
surface of the face shield.
 Disinfect the inner gloves with 70% ethanol and remove apron/gown.
 Laboratory personnel can seek assistance by the trained observer to remove the apron/gown.
Avoid contact of scrubs or disposable garments with outer surface of apron/gown during removal.
Pull apron/gown away from body, rolling inside out and touching only the inside of the gown.
 To remove apron/gown, with one hand unzip the suit from inside. Unzip or unfasten completely
before rolling down and turning inside out. Avoid contact of scrubs with outer surface of coverall
during removal, touching only the inside of the apron/gown.
 Disinfect the inner gloves with 70% ethanol and remove the N95 respirator by tilting the head
slightly forward, grasping first the bottom tie or elastic strap, then the top tie or elastic strap, and
remove without touching the front of the N95 mask. Discard N95 Respirator.
 Disinfect the shoe covers with 70% ethanol and remove while sitting down on comfortable chair.
 Disinfect the inner gloves with 70% ethanol Remove inner gloves safely and clean your hand with
hand sanitizer.
 Perform hand hygiene and wear clean slippers or shoe.
 Remove surgical scrubs .

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ANNEXURE-I: Process Flow charts

Donning procedure Doffing procedure


⇩ ⇩
Perform hand hygiene Disinfect the Outer gloves

Wear on first pair of inner gloves Disinfect and Remove Outer Gloves

Put on Apron/gown Remove the apron

Ensure cuffs of inner gloves are tucked Remove the full-face shield
under the sleeve of the gown

Put on Shoe Covers Remove the N95 respirator

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Put on N95 mask Remove Shoe Covers

Put-on full-face shield over the Remove inner gloves


N95 mask and surgical hood

Disinfect outer-gloved hands with Perform hand hygiene


70% ethanol

C) COLLECTION PROCEDURE

Nasopharyngeal swab (NP SWAB)/Oropharyngeal (Throat) swaB (OP SWAB)

NP swab:

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Insert minitip swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not
upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of
the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from
nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds
to absorb secretions. Slowly remove swab while rotating it. Specimens can be collected from both sides
using the same swab, but it is not necessary to collect specimens from both sides if the minitip is saturated
with fluid from the first collection. If a deviated septum or blockage create difficulty in obtaining the
specimen from one nostril, use the same swab to obtain the specimen from the other nostril.

OP swab:

Insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsillar pillars and
posterior oropharynx and avoid touching the tongue, teeth, and gums.

C)SAMPLE PACKAGAGING AND TRANSPORTATION-

 After collection of NP or OP place it immediately in VTM(Viral transport media)


Viral transport media and Swabs

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 Seal the neck of the sample vials using parafilm.
 Cover the sample vials using absorbent material.
 Arrange Primary container(vial)in secondary container and place it in zip lock pouch.

 Place the zip lock pouch inside a sturdy plastic container and seal the neck of the container.
 Using a thermacol box as an outer container and placing the secondary container within it,
surrounded by hard frozen gel packs.
 Place the completes specimen referral form and request letter inside a leak proof, zip lock
pouch.
 Secure the zip lock pouch with the specimen referral form on outer container.
 Attach the labels properly -Senders address, contact number, Biological substance category B
and handle with care label.

Packaging of COVID -19 sample swab after collection:

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SAMPLE REJECTION CRITERIA –


Dry swab

Any tube that will lack labelling that includes media contents, lot and patient details will be
rejected.
 Sample not received under proper storage conditions will be rejected.
Unsealed sample container will be rejected.

SAMPLE ACCEPTENCE CRITERIA

 ICMR form must be received with sample

 Swab must be properly placed in VTM

 Sealed sample in ziplock pouch Non hemolyzed

 Proper temperature conditions while transporting sample

 Proper labelling on specimen container including name/age/gender (inner container) and other
details like address/name /phone no mentioning “to be tested for COVID19 “ on outer
container.

SAMPLE STORAGE/SAMPLE STABILITY /RETENTION PERIOD

 Sample should be transported immediately to Preventine Health care according to SOP. If it not
transported and processed immediately it should be refrigerated to 2⁰C to 8⁰C.

 Sample storage temperature recommended guidelines (ICMR GUIDELINES) as follows-

Nasopharyngeal/oropharyngeal swab-
 Transported at 4⁰C.
 Till processing ≤5 days 4⁰C

 If Processing >5 days--70⁰C.

 Sample retention period -1 month

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Test Requisition form for Covid-19
INTRODUCTION

This form is for collection centers/ labs to enter details of the samples being tested for
Covid-19. It is mandatory to fill this form for each and every sample being tested. It is
essential that the collection centers/ labs exercise caution to ensure that correct
information is captured in the form. INSTRUCTIONS:

● Inform the local / district / state health authorities, especially surveillance officer for
further guidance

● Seek guidance on requirements for the clinical specimen collection and transport from
nodal officer

● This form may be filled in and shared with the IDSP and forwarded to a lab where testing
is planned

● Fields marked with asterisk (*) are mandatory to be filled

SECTION A – PATIENT DETAILS

Patient Name: ……………………………………….

Age: Gender: Mobile Number:

Present Address: …….……………………………………………………………………………………………………….

Aadhar No:

District of Present Residence: State of Present Residence:

*Nationality:

SECTION B: SPECIMEN INFORMATION FROM REFERRING AGENCY

Specimen type:

Collection date:

SECTION C: PATIENT CATEGORY (PLEASE SELECT ONLY ONE)

Cat 1: Symptomatic international traveler in last 14 days

Cat 2: Symptomatic contact of lab confirmed case

Cat 3: Symptomatic healthcare worker

Cat 4: Hospitalized SARI (Severe Acute Respiratory Illness) patient

Cat 5a: Asymptomatic direct and high-risk contact of lab confirmed case

Cat 5b: Asymptomatic healthcare worker in contact with confirmed case without
adequate protection

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Cat 6: Symptomatic Influenza Like Illness (ILI) patient in hospital/ MoHFW identified
clusters………………………………………………………………………………………………………….

Others……………………………………………………………………………………………………………

(Please select “others" only if the patient doesn’t fall in any other category)

SECTION B- MEDICAL INFORMATION

B.1 EXPOSURE HISTORY (2 WEEKS BEFORE THE ONSET OF SYMPTOMS)

1. Have you been in contact with lab confirmed COVID-19 patient: …………………….

If yes, name of confirmed patient: ……………………………. ………

3. *Were you Quarantined? ………………………………………..

*If yes, where were you quarantined: …………………………………………………………...

Facility 4. Are you a health care worker working in hospital involved in managing patients:

B.2 CLINICAL SYMPTOMS AND SIGNS

Date of onset of symptoms:

First Symptom: …………………………………

Chronic lung disease: Malignancy: Heart disease:

Chronic liver disease Chronic renal disease Diabetes

Immunocompromised condition: ……………………... Other underlying conditions:


………………………

B.4 HOSPITALIZATION DETAILS

Hospitalized: Yes/No

Hospitalization Date: ……………………………

B.5 REFERRING DOCTOR DETAILS

*Name of Doctor: Doctor Mobile No.:

Doctor Email ID:

8. REFERENCE-

1. ICMR Guidelines for sample collection, storage and transportation of n COVID 19 samples.
(RevisedGuidelines April 1,2020)

2. CDC guidelines for sample collection, storage, and transportation of

Plasma for HCV 3.National Laboratory Guidelines for testing of HCV-2018

4. Donning and Doffing PPE: https://www.cdc.gov/vhf/ebola/hcp/

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2.4. SAMPLE COLLECTION FOR OTHER MICROBIOLOGY INVESTIGATIONS

Blood for Culture (AEROBIC / FUNGAL)

 Blood collection is performed only by well-trained experienced phlebotomists (Laboratory technicians


/ Doctors).
 Collect blood during fever / spike phase/before administration of antibiotics.
 Collect 7-10 ml in adults, 3-5 ml in children and 1-2 ml in neonates.
 Number of specimens–Preferably Collect two specimens from two different sites within an hour of
each other or two specimens over 24 hrs
 Requirements – Gather material required for collection and biomedical waste disposal.
 This includes:
Identified patient, Tourniquet, Alcohol wipes, Betadine solution, Sterile syringe and needle (21 G
preferably) or appropriate evacuated containers sets, cotton ball, gloves, alcoholic hand rub solution,
container - Automated blood culture bottle (BacT/Alert bottles) brought to room temperature if
refrigerated and with the top disinfected with alcohol wipes , pre-labeled , needle and syringe
destroyers, sharps can, requisition form, red bag and yellow bag.

Volume of Blood:

Blood culture bottle/Vial Purpose Recommended volume of


blood to be collected (per
bottle)

BacT/ALERT FA Plus Aerobic For adults 8-10 ml

BacT/ALERT PF Plus Aerobic For paediatrics 1-3 ml

Procedure

 Follow instructions as mentioned under collection of blood with the following modifications. Ensure to
follow order of draw as mentioned above.
 Labeling - Pre label the blood culture bottle with the name, registration number, unit, specimen, type
of investigation requested and the date and time of specimen collection.
 Site disinfection - Disinfect the site of collection [patient’s] with an alcohol swab [clinical spirit, 70%
ethyl or isopropyl alcohol]. After use, discard the alcohol swab in the yellow bag.
 Follow this with betadine disinfection in a circular motion beginning from center and moving out.
Allow to dry. Discard the cotton swab in yellow bag.

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 Take a new sterile needle [preferably 21 G for an adult and 22 G for a child] and syringe in front of the
patient. The needle is attached to the syringe.
 Collect adequate volume
 Transfer the blood gently and aseptically into the blood culture bottle along the wall without
squirting. Mix the contents well by placing on a horizontal surface.
 Send the specimen immediately to laboratory.
Note: for automated blood culture please do not put the sticker on the bar code.

CSF FOR CULTURE

Responsibility: Clinician
General instructions:
 The collection of CSF is an invasive technique and should be performed by experienced clinicians
under aseptic conditions
 It is unsafe to do lumbar puncture in case of increased intracranial pressure
 LP should not be performed through infected skin as organisms can be introduced into the
subarachnoid space (SAS)
 Clinician should explain the procedure to patient / relative if patient comatose in detail
 The container should be sterile, screw capped (available from general stores) labeled appropriately
[see general instructions]. DO NOT COLLECT IN PENICILLIN BULBS SINCE THEIR STERILITY IS NOT
MAINTAINED.
 Labeling – as in ‘blood’
 Usually, 3 tubes of CSF are collected for biochemistry, microbiology, and cytology.
 If only one tube of fluid is available, it should be given to the microbiology laboratory
 If more than one tube (1 ml each) is available, the second or third tube should go to the microbiology
laboratory
 Avoid exposure of CSF to excessive cold, heat or sunlight
 IN CASE OF DELAY IN TRANSPORT TO LAB AFTER COLLECTION, STORE AT ROOM TEMPERATURE OR
INCUBATOR ONLY. DO NOT REFRIGERATE.

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Requirements: The kit for collection of CSF should contain:


 skin disinfectant
 sterile gauze and Band-Aid
 lumbar puncture needles: 22 gauge/3.5"for adults;
 23 gauge/2.5" for children
 sterile screw-cap tubes
 sterile gloves
Procedure:
 Analgesia – as per hospital policy.
 Positioning
 Position the patient at the edge of a firm bed and on one side rolled up into a ball.
 The neck is gently ante-flexed and the thighs pulled up toward the abdomen; the shoulders and pelvis
should be vertically aligned without forward or backward tilt
 LP is performed at or below the L3-L4 interspace.
 An alternative to the lateral recumbent position is the seated position. The patient sits at the side of
the bed, with feet supported on a chair. The patient is instructed to curl forward, trying to touch the
nose to the umbilicus.
 A disadvantage of the seated position is that measurement of opening pressure may not be accurate.
 Perform hand hygiene and wear sterile latex gloves
 Disinfect the skin with povidone-iodine or similar disinfectant and drape the area with a sterile cloth
 Inject local anaesthetic as recommended.
 Wait for 5-15 minutes
 The LP needle (typically 20- to 22-gauge) is inserted in the midline, midway between two spinous
processes, and slowly advanced. The bevel of the needle should be maintained in a horizontal
position, parallel to the direction of the duralfibres and with the flat portion of the bevel pointed
upward; this minimizes injury to the fibres as the dura is penetrated.
 When lumbar puncture is performed in patients who are sitting, the bevel should be maintained in
the vertical position.
 In most adults, the needle is advanced 4–5 cm (11/2–2 in.) before the SAS is reached; the examiner
usually recognizes entry as a sudden release of resistance, a "pop."
 If no fluid appears despite apparently correct needle placement, then the needle may be rotated 90°–
180°.
 If there is still no fluid, the stylet is reinserted and the needle is advanced slightly.
 Once the SAS is reached, a manometer is attached to the needle and the opening pressure measured.
 CSF is allowed to drip into collection tubes; it should not be withdrawn with a syringe.
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 Volume - 2-4 ml of CSF should be collected, the rate of collection should be slow, about 4-5 drops a
second [1 ml minimum volume required for culture]
 Prior to removing the LP needle, the stylet is reinserted to avoid the possibility of entrapment of a
nerve root in the dura as the needle is being withdrawn; entrapment could result in a dural CSF leak,
causing headache.
 Following LP, the patient is customarily positioned in a comfortable, recumbent position for 1 h before
rising,
 When the procedure is completed, the needle is removed and an adhesive bandage is placed over the
injection site.
 Label the specimen as described earlier.
 Transport to the laboratory as soon as possible.

BODY FLUIDS (ASCITIC / PLEURAL / PERICARDIAL / PERITONEAL)

 Container, Specification/Materials required:


 Sterile tube /Blood culture bottle
 Labels & hard ball point pen/marker
 Appropriate tray which includes:
 Sterile materials: gloves, cotton, towels, or drapes.
 Local anesthetic, sterilized needle, syringes.
 Skin disinfectants: 10% providone iodine or 70% alcohol
 Two sterile needles and syringes with /without stylet (sterilized)

 Method of collection:
 Locate the appropriate area and clean the skin once with spirit using circular swabbing
in increasing circles from within outwards.
 Keep the labelled sterile tube handy.
 Wash your hands with soap and water and wear sterile gloves.
 Cover the area with a sterile drape.
 Clean intended skin site with povidione iodine, followed by methylated spirit / 70%
alcohol again. Allow to dry. Collect the sample (8-10ml) from appropriate site with full
aseptic precautions
 Transfer to sterile tube (ensure the plug does not get contaminated)

 Transport:
 The sterile tube should be transported to the laboratory as early as possible.
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 If a delay is expected keep at room temperature. DO NOT refrigerate.

 Rejection Criteria:
 Sample without appropriate label.

Collection of Upper Respiratory Tract Specimens

Types of specimen:

 Throat swab
 Nasopharyngeal swab
 Nasal swab

Requirement:

 Sterile swab
 Container - Sterile test tube, screw capped / cotton plugged to place the swab, VTM as in case of
COVID 19 and flu
 Clean tongue depressor
 Source of light
 PPE in case of COVID 19 suspect

General instructions:

 Follow airborne precautions and standard precautions

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 In suspected cases of COVID 19, diphtheria, flu, swabs should be collected both from the throat and
the nose
 In suspected cases of COVID 19 swabs should be collected both from the throat and the nasopharynx,
as per ICMR guidelines
 In case of COVID 19, flu, use the special swab provided with the viral transport medium (VTM).
Maintain cold chain in triple pack while transport.
 Do not obtain throat samples if epiglottis is inflamed, as sampling may cause serious respiratory
obstruction

Procedure:

 Perform hand hygiene.


 Wear appropriate mask / respirator / PPE for personal protection.
 Wear clean / sterile gloves.
 Ask patient to open his / her mouth without putting out his tongue and to say ‘Ahhhhh….’
 While the patient is saying ‘Ahhhhh’, press down the outer two third of tongue with tongue
depressor, using the left hand, enabling the tonsils and back of the throat to become visible.
 Introduce the swab with right hand between the tonsillar pillars and behind the uvula, while avoiding
touching the tongue, cheeks, uvula, or lips.
 Rub the swab firmly against the inflamed part for 5 seconds while turning it round
 In case of suspected diphtheria, swab the membrane if present and If nothing abnormal is seen, swab
the tonsils, the fauces and the back of the soft palate
 Take two swabs and immediately plug the same in sterile test tubes
 Specimens should be transported to the laboratory immediately after labelling and properly filling up
the requisition form.

Collection of Lower Respiratory Tract Specimens:

Types of specimen:

Lower Respiratory Tract Specimens include:


a) Sputum –expectorated
b) Sputum - induced
c) Bronchial washings
d) Broncho alveolar lavage [BAL]
e) Mini-BAL
f) Endotracheal aspirates
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g) Tracheal swabs
h) Bronchial aspirate
i) Bronchial brushing
j) Protected catheter brush specimen
k) Transthoracic aspirates
l) Trans tracheal aspirate
m) Open Lung biopsies

Responsibility:

Clinician (or nursing assistant depending on invasiveness of procedure)

a) Sputum –expectorated:
Requirement:
 Patients without complaints of cough with expectoration should preferably not be referred for
sputum examination.
 For culture - The container should be sterile, wide-mouthed, screw-capped with a capacity of
approximately 15-20 ml and labeled. The container can be procured from 4th floor Department of
Microbiology / general stores. The procedure of collection should be explained to the patient. This
includes:
 Explaining the difference between saliva (spit) and sputum.
 Explaining the cough etiquette and its importance
 For sputum microscopy (acid fast bacilli) clean, screw capped containers are provided by OPD
28/DOTS centre.
 Collection:
Volume – 2-5 ml

Number of specimens:

One for bacterial culture

Two (one early morning and one spot) for

sputum AFB examination

 Collection should be done in a well-ventilated area away from people especially children.
 The patient should first rinse his/her mouth with plain water.
 The patient should open the container without contamination, breathe slowly and deeply, bend
forward and generate a deep cough.
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 Collect the expectorant in the container by pressing the rim of the container under the lower lip to
catch the entire expectorated cough sample
 After collection, the cap of the container should be tightly screwed.
 Any spilled material on the outside should be wiped off with a tissue moistened with 1% sodium
hypochlorite or alcohol, and care should be taken not to let any disinfectant enter the container.
 If the collection is done at home, visible contamination should be wiped
off with house hold bleach.
 It should be ensured that the sputum sample is of good quality. A good quality sputum sample is thick,
purulent and sufficient in amount (2-3ml).
 Fill the form and send sample immediately to laboratory.

b) Sputum – Induced
 When sputum production is scanty, induction with physiotherapy, postural drainage, or nebulized
saline may be effective.

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 This procedure should be carried out in an area which is isolated and preferably under negative
pressure or well ventilated without other humans around.
 Allow the patient to breathe aerosolized droplets of a solution containing 15% sodium chloride and
10% glycerin for 10 minutes or until a strong cough reflex is generated.
 Collect the sputum thus generated (which tends to be watery) in a sterile screw capped labeled
container (as for sputum above) and send to the laboratory immediately along with the duly filled
requisition form.
 Mention that the specimen is induced sputum in order to avoid specimen rejection.

c) Bronchial washings
 Bronchial washings are collected in a similar fashion to bronchial aspirate (see below), but the
procedure involves the aspiration of small amounts of instilled saline from the large airways of the
respiratory tract.
 Container – Sterile screw capped test tube

d) Broncho alveolar lavage (BAL) culture


 The sampling area is selected based on the correspondent area of the infiltrate on chest radiograph or
by the visualization of a sub segment containing purulent secretions.
 A volume of sterile saline is instilled and then gently aspirated. (approximately 100 ml)
 Approximately 5 ml lavage is to be sent to the laboratory for microbiological examination/ cytological
examination.
 Container – Sterile screw capped test tube

e) Endotracheal aspirate
 Indication - in intubated patients with suspicion of pulmonary infection
 Position the tip of the bronchoscope close to the segmental area corresponding to radiographic
infiltrates.
 Instill 3 aliquots of 50 mL or 5 aliquots of 30 mL saline
 After the injection of each aliquot, gently aspirate through the suction channel.
 Send atleast 10 ml of the aspirate for microscopy and culture.
 Container – Sterile screw capped test tube

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f) Bronchial aspirate

These are collected by direct aspiration of material from the large airways

of the respiratory tract by means of a flexible bronchoscope. Approximately 5 ml lavage is to be sent


to the laboratory for microbiological examination /cytological examination.

Collection of Ear Swab

 Use sterile swab stick


 Collect under direct vision
 Do not instill antibiotic / antiseptic into the ear prior to collection
 Allow the swab to soak in the exudate for 10 seconds
 Place in sterile container (plugged / screw capped test tube), label and transport immediately.

Collection of Eye Swab (CORNEAL/ CONJUNCTIVAL)

 Moisten the swab in sterile normal saline


 Hold the swab parallel to the cornea and gently rub the lower conjunctiva
 Place in sterile container (plugged / screw capped test tube), label and transport immediately.

Collection of Urine: CLEAN CATCH

Urine in non-catheterized individuals


 Provide adequate instructions on what to collect (mid-stream) and how much to collect (5ml) and
container (screw capped sterile container) to be used, to patients for clean catch mid-stream urine
specimens. In case there is likely to be a delay in transport, refrigerate the specimen ( 4°C)
 Men: Retract the prepuce and clean the urethral meatus with soap and
water. Collect mid-stream urine.
 Women: Clean the periurethral area with soap and water, movement
being directed front to back. Repeat twice. Collect mid-stream urine.

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Urine –catheterized
 Decontaminate / Disinfect catheter specimen port with alcohol wipe.
 Using a sterile syringe and needle collected 5 ml urine form catheter specimen port.
 Transfer the specimen to the appropriate urine container ( screw capped containers, sterile)
 In case there is likely to be a delay in transport, refrigerate the specimen
(4°C)

Urine – Suspected tuberculosis


 Early morning urine , 25-30 ml, on three to five consecutive days

Collection of Stool Specimen:

 Collect fresh stool specimen in a decontaminated and well rinsed bed pan.
 Transfer one teaspoonful to the appropriate screw capped container.

Collection of Skin, Nail and Hair for fungal examination:

Collect skin scraping, hair and nail clippings in a petridish / test tube and maintain at room
temperature

a) Skin scrapings
 Identify the site of lesion from where collection is to be made.
[An appropriate lesion is peripheral, erythematous, growing margins of typical ring worm lesion.]
 Inform the patient about the procedure.
 Collect specimen with strict aseptic precautions.
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 Make patient sit comfortably.


 Clean the identified lesion thoroughly with 70% alcohol to remove the surface bacterial
contamination.
 Using sterile scalpel blade surface collect multiple scrapings from the identified lesion preferably from
the edge of lesion including the adjacent healthy skin.
 Collect the specimen in petri dish, filter paper or clean paper.
b) Nail
 Clean the affected nail with spirit
 Collect debris under the nail with scalpel in petridish
 Pick up flakes after wetting loop with sterile saline from petridish for processing
 If nail is avulsed then it should be cut in small pieces for processing.
c) Hair:
 Hair should be collected from areas of scaling or alopecia.
 Clean the affected area with spirit.
 With sterilized forceps, pluck hair or stubs (at least 10-12) in grey patch or scrape with scalpel in black
dot type of hair infection.

d) Skin Biopsy
 Decontaminate skin with 70% methylated spirit / alcohol.
 Select the edge of the lesion.
 Take a biopsy with autoclaved instrument under all aseptic measures.
 Cut biopsy tissue in small pieces and crush in mortal and pestle.
e) Mycetoma granules
 From suspected mycetoma, look for granules in the lesions using hand lens.
 Wash the granules in several changes of sterile distilled water
 Crush the granules and then inoculate.

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 If granules are absent collect the purulent/necrotic material.


f) Ophthalmic specimens - corneal scrape and conjunctival scraping
 To be collected only by ophthalmologist.
 After anaesthetizing the eye with local anaesthetics, retract the lid with retractor.
 Using the blunt edge of sterile scalpel blade, scrape the ulcerated area away from the pupillary area.
 Wipe the scrapings on a sterile swab stick wetted with broth
 Collect more scrapings in similar way for smear and KOH mount.

Collection of Pus

 Aspirate pus through a sterile syringe and needle where possible.


 Transfer a portion (1-2ml) to a screw capped sterile container(test tube)
 For anaerobic organisms, transfer specimen to Robertson’s cooked meat medium / Thioglycollate
medium for culture. The medium is available from media room, Department of Microbiology, 4th floor
college building and in Emergency Laboratory.

Collection of Wound Swab:

 Not a good quality specimen


 Aspirated fluid / tissue preferred
 If swabs only can be collected, use a sterile swab.
 Clean the wound with sterile distilled water / normal saline wipes.
 Place the swab in the wound and rotate gently for 10 seconds allowing the secretions to be soaked.

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 Place in a sterile labeled container (test tube, plugged / screw capped) aseptically and transport
immediately to lab.
 Collect more than one swab if possible.

2.5. Sample collection for Newborn screening

Urine on Filter paper- UFP

 Make sure that all the information in the Card is duly filled and recheck with the Parents.

 The Sample can be collected with one of the methods mentioned

Method I

a. Hold the green portion of the filter paper to collect the sample

b. Hold the filter paper close to the genital area of your baby until your baby passes urine
directly on it.

Method II

a. Hold the green portion of the filter paper to collect the sample

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b. Collect 20-25 ml of urine in a clean sterile plastic container. Hold the filter paper from the
colored end and soak it in the collected urine sample.

 Thoroughly Air Dry by hanging with clip or keeping on a clean, flat and STERILE surface for around half
an hour to one hour.

 Mail completed form with sample to the laboratory soon after collection and drying the same.

Dried blood spot- DBS

Make sure that all the information in the Card is duly filled and recheck with the Parents.

 Visually demarcate the site

 Shaded area ( //////// ) indicates safe areas for puncture site

 The safest area can be visualized as median to a line drawn posteriorly from the middle of greater
toe to the heel or lateral to a line drawn from between the 4th and 5th toe to the heel.

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 Warm the prick site by massaging gently or with soft cloth, moistened with warm water, for three
to five minutes

 Cleanse site with alcohol prep & Wipe DRY with sterile gauze pad

 With the lancet, puncture the heel skin with one continuous, deliberate motion at a slight angle (a
little less than 90 degrees).

 Wipe away first blood drop with sterile gauze pad ( as it is likely to contain tissue fluids that can
contaminate the specimen)

 Allow another LARGE blood drop to form Lightly touch filter paper to LARGE blood drop

 Thoroughly dry blood spots on a sterile, dry, clean, flat, nonabsorbent surface for around30 mins.

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 Mail completed form with sample to the laboratory soon after collection and drying the same

g. Cord blood spot for Newborn screening

 Rub your gloved hands with 5-10 ml isopropyl alcohol or spirit and allow drying

 Preparing the cord for good sample collection. Wipe DRY with sterile gauze pad

 Prick the umbilical cord vein using syringe and needle.

 Withdraw 2ml of blood from the umbilical cord vein. Remove needle from syringe and fill the four
circles, each with a Single Free Flowing drop of blood

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 Thoroughly air dry the blood spots by hanging with clip or by keeping on a sterile, dry, clean, flat,
non absorbent surface for around 30 min or till its completely dried

3.0. Instructions for completion of the request form:

Test request forms are provided on Online portal to respective client, hospitals and other laboratories
to which they can log in using their Username & Password.

The Online TRF asks for routine testing following information of the patient, which should be filled at
the time of sample collection.

 Patient Name*
 Age (Year/Month/Day)*
 Gender (male or female)*
 Hospital Name
 Referring Clinician
 Contact details (Mobile no & mail id)
 Portal image of Online TRF
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Doc. No: GD/PSCM Primary Sample Collection Manual
Issue No: 03 Issue Date: 01.10.2021 Amend No: 0 Amend Date: Effective date: 01.10.2021 Page 42 of 51
Primary Sample Collection Manual


 Tests/Package name *
 0Sample type (Serum/whole blood/ urine/ Fluid)*
 Date of collection*
 Accurate Barcode*
 Other relevant information which may affect test result
 HIV consent form
 During the Online TRF asks for Prenatal screening, Ultrasonography report scan, Gestational
age (as per scan & as per collection date), Sonography scan, should be filled accurately. This will
help to selection of accurate test like double/triple marker.

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Doc. No: GD/PSCM Primary Sample Collection Manual
Issue No: 03 Issue Date: 01.10.2021 Amend No: 0 Amend Date: Effective date: 01.10.2021 Page 43 of 51
Primary Sample Collection Manual

Note: * is mandatory information required field as well as address is mandatory for


investigations of notified diseases

4.0. Instructions for obtaining consent:

 All parents presenting themselves in the laboratory/client laboratories for routine procedures, it is
assumed that parents have given consent for relative procedure.

 For PLC, the routine procedures include Phlebotomy & self-collection of urine sample by the patient.

 As per NACO Guidelines, mandatory consent must be obtained from the patient for HIV testing as per
the consent form enclosed as annexure II.

 For Newborn Screening: -

 It is the responsibility after the referral hospitals to obtain consent from the parents of
the newborn child.

GENERAL DIAGNOSTICS INTERNATIONAL (P) Ltd.


Doc. No: GD/PSCM Primary Sample Collection Manual
Issue No: 03 Issue Date: 01.10.2021 Amend No: 0 Amend Date: Effective date: 01.10.2021 Page 44 of 51
Primary Sample Collection Manual

 For any other invasive procedures, it is mandatory to the obtain consent from the
patient/ close relative (in case of Minor) & send the hard copy/soft copy of consent to
the laboratory along with sample.

 FOR COVID 19 RT PCR TEST - It is the responsibility of the referral hospital/clinic/lab to


fill the details on ICMR sample collection referral form for the patient testing for COVID
19 RT PCR TEST

5.0. Instructions for sample transport:

Safe transport of specimen is essential for maintaining specimen integrity, safe of personnel and
environment and accurate test result

Triple layer packaging system as per WHO guideline for transportation of infectious substance
which are as follows.

 “Primary receptacles shall be packed in secondary packaging in such a way that, under normal
condition of transport, they cannot break, be punctured or leak their contents into the secondary
packaging.
 Secondary packaging shall be secured in outer packaging with suitable cushioning material. Any
leakage of the contents shall not compromised the integrity of the cushioning material or of the outer
packaging”
 The transport box or outer packaging should be handled with care. Keep package upright in a secure in
position;
 Keep and transport at compatible condition and in specified time.

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Doc. No: GD/PSCM Primary Sample Collection Manual
Issue No: 03 Issue Date: 01.10.2021 Amend No: 0 Amend Date: Effective date: 01.10.2021 Page 45 of 51
Primary Sample Collection Manual

6.0. SPECIMEN RECEIPT AND ACCEPTANCE

 The specimens are accepted at the reception counter.


 This section is manned by a trained laboratory staff.
 The designated person checks transport conditions and instructs for corrections if deviations found.
 Temperature records of the samples is recorded for each packet of samples. If temperature is
beyond 2-80C, then the samples are rejected or opinion of concerned SSO is taken.
Specimen acceptance criteria:
 Appropriate specimen
 Appropriately labelled container
 Appropriate volume
 Appropriate transport
 Completely filled data on the lab portal
 No breakage / leakage / soiling of container / requisition form

Specimen Rejection Criteria:

 Incomplete requisition
 Insufficient specimen quantity
 Hemolyzed blood specimen
 Lipemic blood specimen
 Leaking or broken specimen container
 Written consent not taken for HIV testing
 For culture, cotton plug contaminated with specimen
 For culture, Foley’s tip.
 For culture, open containers
 For culture, specimen in formalin
 Specimen in wrong container

GENERAL DIAGNOSTICS INTERNATIONAL (P) Ltd.


Doc. No: GD/PSCM Primary Sample Collection Manual
Issue No: 03 Issue Date: 01.10.2021 Amend No: 0 Amend Date: Effective date: 01.10.2021 Page 46 of 51
Primary Sample Collection Manual

7.0. Sample storage & retention:


Samples after processing are stored & retained as per the table given below.

Storage
S. No Sample type Storage period
Temp
1 BG EDTA tubes Hb HPLC samples 2-8°C 7 Days ( Hemolyzate)
2 BG DBS 2-8°C 30 days
3 BG Urine on FP (DUS) 2-8°C 30 days
Plain/ gel tubes for Protein
4 BG 2-8°C 7 Days
electrophoresis
Plain/ gel tubes for serum
5 BG 2-8°C 7 Days
amino acids
6 Biochemistry Fluoride Tubes 2-8°C 3 days
7 Biochemistry Plain/ gel tubes 2-8°C 3 days
8 Biochemistry Citrate Tube (Biochemistry) 2-8°C 72Hrs.
9 Biochemistry Urine (Biochemistry) 2-8°C 24 Hrs.
10 Hematology EDTA tubes Non HPLC samples 2-8°C 72 Hours
11 Hematology Citrate tubes (Hematology) 2-8°C 24 Hours
12 Hematology Urine routine & Microscopy 2-8°C 24 Hours
13 Microbiology Urine C/S 2-8°C 3/4 days
14 Microbiology Blood C/S RT 3/4 days
15 Microbiology Catheter tip,Swab specimens RT 3/4 days
16 Microbiology Sputum C/S 2-8°C 3/4 days
17 Microbiology Pus C/S 2-8°C 3/4 days
18 Microbiology Stool C/S 2-8°C 3/4 days
19 Microbiology Body fluid C/S RT 3/4 days
Molecular testing(RNA /DNA
Positive: 6 mths,
20 Microbiology extract) HBV/HCV/HIV -70°C
Negative: 1 mth
/COVID-19

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Doc. No: GD/PSCM Primary Sample Collection Manual
Issue No: 03 Issue Date: 01.10.2021 Amend No: 0 Amend Date: Effective date: 01.10.2021 Page 47 of 51
Primary Sample Collection Manual

8.0. DISPOSAL OF WASTE GENERATED

 Segregate waste into appropriate colour coded bags / containers


 All blood soaked non plastic items in yellow bags
 All infected plastics in red bag
 All sharps in sharps disposal container. Do not disassemble needle and syringe assembly.
 Untreated waste should not be stored beyond 48 hrs.
 The red and yellow bags and the sharp cans should be tied, autoclaved & then labeled and
handed over to biomedical waste collection agency. Records of biomedical waste to be
maintained.
 Please refer to Biosafety manual for SOP of biomedical waste disposal.

GENERAL DIAGNOSTICS INTERNATIONAL (P) Ltd.


Doc. No: GD/PSCM Primary Sample Collection Manual
Issue No: 03 Issue Date: 01.10.2021 Amend No: 0 Amend Date: Effective date: 01.10.2021 Page 48 of 51
Primary Sample Collection Manual

Annexure I : HIV consent form

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Doc. No: GD/PSCM Primary Sample Collection Manual
Issue No: 03 Issue Date: 01.10.2021 Amend No: 0 Amend Date: Effective date: 01.10.2021 Page 49 of 51
Primary Sample Collection Manual

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Doc. No: GD/PSCM Primary Sample Collection Manual
Issue No: 03 Issue Date: 01.10.2021 Amend No: 0 Amend Date: Effective date: 01.10.2021 Page 50 of 51
Primary Sample Collection Manual

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Doc. No: GD/PSCM Primary Sample Collection Manual
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