AAC 6 Lab Services Policy

Hospital Policy Manual Laboratory Services
NABH Standard Reference: AAC 6
Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

/Ver. No 4/ Rev 00
Laboratory Services Manual
ORANGE CITY HOSPITAL AND RESEARCH INSTITUTE,

NAGPUR
Review By: Approved By: Issued By:
Name: Name: Name:

Dr. Suchit Barapatre Dr. Vidya Nair Dr. Priya Maheshwari
Lab Director Vice-Chairperson QA Head
Signature Signature Signature
Date: Date: Date:
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CONTROL OF THE MANUAL
The holder of the copy of this manual is responsible for maintaining it in good and safe condition
and in a readily identifiable and retrievable.
The holder of the copy of this Manual shall maintain it in current status by inserting latest
amendments as and when the amended versions are received.
QA Head is responsible for issuing the amended copies to the copyholders, the copyholder should
acknowledge the same and he /she should return the obsolete copies to the Quality Department.
The amendment sheet, to be updated (as and when amendments received) and referred for details
of amendments issued.
The manual is reviewed once a year and is updated as relevant to the hospital policies and
procedures. Review and amendment can happen also as corrective actions to the non-conformities
raised during the self-assessment or assessment audits by NABH.
The procedure manual with original signatures of the above on the title page is considered as
‘Master Copy’, kept in the authority of quality department and the photocopies of the master copy
for the distribution are considered as ‘Controlled Copy’.
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AMENDMENT SHEET
S.No. Section no & Details of the Reasons Signature of Signature of

page no amendment the the approval
preparatory authority
authority
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PURPOSE
1.1 To establish a manual covering work methodology, discipline and safety aspect applicable to the
laboratory activities at OCHRI. Laboratory services at OCHRI are outsourced under Orange city
Laboratory services.
2.0 SCOPE
2.1 The services of lab are applicable to inpatients, outpatients and emergency patients.
2.2 This procedure addresses the requirements of
(a) AAC.6 bearing the title ‘Laboratory services are provided as per the scope of services of the
organisation’ of first chapter of NABH 4th Edition
3.0 POLICY
3.1 OCHRI believes in maintaining confidentiality and providing accurate results on time to its patients
that enables in appropriate patient care.
4.0 RESPONSIBILITY
4.1 All Lab staffs
5.0 Department Overview
5.1 Structure –
Pathology Laboratory of the OCLS provides diagnostic service in the field of Laboratory to the
patients at OCHRI, NAGPUR. It is located on the 2nd floor of Deep apartment at Orange city hospital
and research institute, NAGPUR hospital building.
5.2 Staff –
 Laboratory Director - Dr. Suchit Barapatre
 Technicians
• Mr. Vipin Ghotkar
• Mr. Sushil Thool
• Mrs. Preeti Gajbhiye
• Miss Sheetal Barange
• Miss Monali Patte
• Ms. Deepika Agrawal
• Ms. Soniya Nagpure
• Ms. Pooja Dabarase
• Ms. Pooja Mankar
 Pathology Attendant
• Ms. Poonam Lilhare
• Ms. Kajal Vahile
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5.3Facilities and Equipment –

 A15 Biosystems
 Microlab – 300 (2)
 Nulyte – Smart ( Na,K )
 Cell DYN - Emerald
 Nyco – card – Reader -2
 Incubator
 Oven ( Coslab )
 Refrigerator -2
 Laboratory Centrifuge – 2 (REMI)
 Autoclave
5.3 Tests offered –

BIOCHEMISTRY Lipid Profile C.B.C Reticulocyte Count
BILLIRUBIN HBA1c Coagulation Profile P.S.For Mf
Serum Lipase Serum Potassium Blood Grouping and Rh Type P.T.T.
Serum Magnesium SGPT ESR Peripheral Smear study (PS)
Ada Level Serum Sodium HB P.S. for Malaria Parasite
Serum Albumin Uric Acid HAEMATOLOGY APTT
SERUM IRON SGOT DLC HISTOPATHOLOGY
Protein Total and AG Ratio Urea Bt/Ct Histopatho Large (1st Section)
SERUM IONIC CALCIUM Calcium PV/PF Histopatho - Small (Ist Section)
RA Factor Blood Urea PS For Opinion (Anaemia) Histopathology (Special Stains)
SERUM IRON BINDING
CAPACITY Serum Ammonia C.B.C Sickle Cell Preparation
Blood sugar Post-meal Glycosylated Hb / Hb 1 Ac Coagulation Profile special stain
Total CPK(CK-NAC) G6PD Quantative Assay Blood Grouping and Rh Type Slides For 2nd Opinion
LDH (Lactate Biopsy/Tapping - Transthoracic
Serum Phosphorus Dehydrogenase) ESR Lung Biopsy
Glucose Screening Test SERUM CHOLESTEROL HB HISTO PATHOLOGY
SODIUM Platelate Count TLC Histological Exam
Iron Binding Capacity CYTOLOGY Prothrombin Time BLOCK FOR HISTOPATHOLOGY
POTASSIUM PAP SMEAR DLC Paraffin Section
FNAC WITH CYTOLOGICAL
KFT REPORT Bt/Ct
LFT (TOTAL) Cytology PV/PF
Blood Sugar Random FNAC Platelet Count
Blood Sugar Fbs BLOOD FOR C/S PS For Opinion (Anemia)
Blood Sugar Pp STOOL FOR C/S PCV (Hematocrit)
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Serum Creatinine Pleural Fluid for Cytology Sickle Cell Test

HORMONES SEROLOGY Glycosylated Hb / Hb 1 Ac Bleeding Time
TSH (Thyroid Stimulating
Hormone) HIV (SCREENING) PSA (PROSTATIC SPECIFIC ANTIGE Absolute Eosinophil Count
SMEAR FOR MALARIAL
T3,T4,TSH Australia Antigen (Hbs Ag) CPK MB PARASITE
T4(Thyroxine) HCV (Screening) Vitamin D(25 Hydroxy Vit D Total) Platelet Concentrate
T3(Triiodothyronine) NS1 Antigen FERRITIN STOOL
TSH Widal High Sensitive Troponin I Occult Blood Stools
MICROBIOLOGY Dengue igG / igM / NS1 Papanicula Smear STOOL FOR ROUTINE
CULTURE & SENSITIVITY DENGUE IGM Troponin T New STOOL OCCULT BLOOD
Hanging
Drop
OT Swab One Dengue IgG PSA Stool Routine
GRAMS STAIN SERUM IRON Procalcitonin Level
AFB STAIN V.D.R.L Nt-Pro Bnp FLUID EXAMINATION
Sputum For AFB Serum Ige Beta Hcg Albumin(Fluid)
Fungus Antinuclear Antibodies VitD3 assay TUMOR MARKERS
Sputum C/S HCV Serum Ige Ca 125
CULTURE OTHERS RAPID Dengue igG / igM HBsAg by ELISA CA-125
CULTURE & SENSITIVITY -
EAR SWAB LEPTOSPIRA IGM Serum Iron and Tibc SEMEN ANALYSIS
Leptospira LEPTOSPIRA IgG and IgM Total Protein Alb/Glo Ratio FUNGAL STAIN
CSF For India Ink
Preparation Monteux Anti HCV Total Semen Analysis
Throat Swab Hiv Spot URINE FUNGAL CULTURE
Urine Calcium LEPTOSPIRA IGG Urine Routine
CULTURE & SENSITIVITY -
HVS DENGUE ANTIGEN Urine protein/creatinine ratio
PUS FOR C/S Hbs Ag Spot Urine C/S
Stool For Hanging Drop
Preparation HIV 1 and 2 24 hrs Urinary Protein
AFB - SPUTUM (SAMPLE I) HBs Ag Urine Bile Pigment and Bile Salts
FUNGAL STAIN Hcg (Maternal) Urinary Ketone
Ascetic Fluid C/S A.S.O.Titre Urine Micro albumin
Koh Preparation (Fungus) TROPONIN - I Urine for Trypsinogen-2
Fungal Culture/Sensitivity HIV TEST ELISA/CLIA Urine Microalbuminuria
SPUTUM FOR C/S V.D.R.L. Pregnancy Test
Pus for Culture and
Sensitivity SPECIAL INVESTIGATION Urine Test for Nicotine
Clot Retraction Time Urine Occult Blood
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Urinary Copper Urine for Hemoglobinuria

SPECIAL TEST
Eosinophil Count
5.4 Laboratory -
List of Forms & Records
Records Description Location Retention

Period
OPD Register PL
IPD Register PL
Cytology Register PL
Histopathology Register PL
Critical results alert register PL
Internal quality control register PL
External quality control register PL
ReDo register PL
Temperature log Register - Refrigerator PL
Equipment calibration record PL
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7.0 Procedure:
7.1 Ordering of Tests:
OPD: By OCHRI OPD consultants, Outside Consultants
IPD: Requisition slip
All blood collection procedures begin with the receipt of a test requisition form generated by or at the
request of a health-care provider. The requisition is essential to provide the blood collector with the
information needed to correctly identify the patient, organize the necessary equipment, collect the
appropriate specimens, and provide legal protection. Blood specimens should not be collected without
a requisition form, and this form must accompany the specimens sent to the laboratory.
Requisitions must contain certain basic information to ensure that the specimen drawn and the test
results are correlated to the appropriate patient and the results can be correctly interpreted with regard
to any special conditions, such as the time of collection.
The information on our lab’s requisition slip include the following:
• Patient’s name and identification number (M.R.no)

• IPD no.
• Age/sex
• Date and time of specimen collection
• Name of the referring doctor
• Patient’s location (Ward)
• Clinical history.
• Probable diagnosis
• Tests requested
 Types of Specimen
• The laboratory refers to blood specimens primarily in terms of whole blood, plasma, and
serum.
• A whole blood specimen contains erythrocytes, leukocytes, and platelets suspended in plasma
and essentially represent blood as it circulates through the body. Tests related to blood cells,
such as the complete blood count (CBC) and blood typing, are performed on whole blood.
• The majority of laboratory tests are performed on the liquid portion of blood (plasma or
serum), which contains substances, such as proteins, enzymes, organic and inorganic
chemicals, and antibodies.
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• Plasma is the liquid portion of blood that has not clotted; serum is the liquid portion remaining
after clotting has occurred. Plasma is often defined as the liquid portion of blood that contains
fibrinogen and other clotting factors, and serum as the liquid portion that does not contain
fibrinogen and other clotting factors. Both serum and plasma are obtained by centrifugation of
clotted and unclotted specimens, which separates the cellular elements from the liquid portion
7.2 Collection, Identification and Transportation:

 Greet the Patient
• The blood collector should introduce himself or herself and ask permission to collect a blood
specimen. This interaction begins the communication process and develops trust with the patient.
• The procedure must be explained in nontechnical terms and understood by the patient. The patient
is then able to give informed consent to the procedure. Consent may be verbal or nonverbal
indicated by extending the arm or rolling up the sleeve
 Identify the Patient

• The most important step in the venipuncture procedure is the correct identification of the patient.
To ensure that blood is drawn from the right patient, compare the information obtained verbally
with the information on the requisition slip. Verbal identification is made after the patient greeting
by asking the patient to state his or her full name. In an outpatient setting, comparison of verbal
information with the requisition form may be the only means of verifying identification.
• For samples received from in-patients, compare the labeled specimen with request slip
• This ensures that specimens are correctly labeled at the patient’s bedside.
 Prepare and Position the Patient

• The patient must be positioned conveniently and safely for the procedure. Provide a brief
explanation of the procedure.
• Patients should not be told that the procedure will be painless.
• While talking with the patient, verify that any pretest preparation, such as fasting or abstaining
from medications, has occurred. When these procedures have not been followed and the specimen
is still required, the irregular condition, such as non-fasting, should be noted on the requisition
form and on the specimen.
• To guard against a possible episode of syncope, patients should always be sitting or lying down
when phlebotomy is performed. Never draw blood from a patient who is standing.
• Outpatients are seated or reclined in a drawing chair. Patients who have had previous difficulties
during venipuncture should lie down for the procedure. The arm should be firmly supported and
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extended downward in a straight line, allowing the tube to fill from the bottom up to prevent reflux
and anticoagulant carryover between sample tubes.
• Before approaching the patient for the actual venipuncture, the blood collector should collect all
necessary supplies (including collection equipment, antiseptic pads, gauze pads, bandages, and
needle disposal system) and place them close to the patient.
• Reexamine the requisition form, and select the appropriate number and type of collection tubes.
• Place the tubes in the correct order for specimen collection, and have additional tubes readily
available for possible use during the procedure.
 Different blood collection tubes are as under:
1. Plain tube: This tube without any anticoagulant is used for investigations which require serum
sample.
The following anti coagulant tubes are used in medical laboratory for investigations which require
whole blood or plasma. The amount of blood to be collected in various tubes will depend on the
tube used (The exact amount that should be collected is mentioned on tube)
2. EDTA: EDTA coated tubes are violet capped tubes. Commonly used for Hematological
investigations like Complete blood count, Haemogram, G6PD, Sickling Hemoglobin, HbA1C,
Trop – T, Hb Electrophoresis etc. 1 ml blood has requirement of 0.1 gm of EDTA for proper
preservation of morphology of cells.
3. 3.2 % Sodium Citrate: These are blue capped tubes, used for coagulation profile, D. Dimer,
fibrinogen etc. 1:9 ratio of anticoagulant to blood should be strictly maintained for accuracy of
results. For Erythrocyte sedimentation rate, we use 1:4 ratio of anti coagulant and blood, these
are black capped tubes.
4. Fluoride: These are Gray capped tubes used for preservation of glucose.
5. Heparin: Heparin tubes are green capped tubes, used for estimation of ammonia, bicarbonate,
HLA B – 27 etc. Heparinized syringes are used for arterial blood gas estimation.
 Label the Tubes

• Tubes must be labeled at the time of specimen collection, before leaving the patient’s room or
dismissing an outpatient. Tubes are labeled by applying a sticking plats label bearing patient
details
• Information on the specimen label should include:
OPD- Patient’s name and collection register ID number
IPD- Patient’s name and IPD no.
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 Wash Hands and Wear Gloves

• Always wear clean gloves at the start of the day & whenever necessary and wash hands
before and after the procedure.
 Apply the Tourniquet

• The tourniquet serves two functions in the venipuncture procedure. By causing blood to
accumulate in the veins, the tourniquet causes the veins to be more easily located and also
provides a larger amount of blood for collection. Use of a tourniquet can alter some test
results by increasing the ratio of cellular elements to plasma (hem concentration) and by
causing hemolysis.
 Select the Venipuncture Site

• The preferred site for venipuncture is the ante-cubital fossa located anterior to the elbow.
The median cubital, cephalic, and basilic veins are located in this area, and in most patients
at least one of these veins can be easily located.
• Of the three veins located in the ante-cubital area, the median cubital is the vein of choice
because it is large, well anchored, and does not tend to move when the needle is inserted. It
is often closer to the surface of the skin, more isolated from underlying structures, and the
least painful to puncture as there are fewer nerve endings in this area.
• The cephalic vein should be the second choice if the median cubital is inaccessible in both
arms.
• The basilic vein should be used as the last choice because the median nerve and brachial
artery are in close proximity to it, increasing the risk of injury. The basilic vein is the least
firmly anchored; therefore, it has a tendency to roll and hematoma formation is more likely.
Using a syringe method for blood collection from the basilic vein offers more control over
a rolling vein. The basilic vein is located near the brachial artery and extreme care must be
taken not to accidentally puncture the artery.
• Two routine steps in the venipuncture procedure aid in locating a suitable vein: applying a
tourniquet and asking the patient to clench his or her fist.
• Continuous clenching or pumping of the fist is not recommended because it will result in
hemoconcentration, altering some test results, such as potassium and ionized calcium. The
tourniquet can be applied for only 1 minute; therefore, after the vein is located, the
tourniquet should be removed while the site is being cleansed, and then reapplied
immediately before the venipuncture.
• The palpation of veins is performed by using the tip of the index finger. The pressure
applied by palpating locates deep veins and distinguishes veins, which feel like spongy
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cords, from rigid tendon cords. Veins must be differentiated from arteries, which produce a
pulse; therefore, the thumb should not be used to palpate because it has a pulse beat.
• If no palpable veins are found in the antecubital area, the wrist and the back of the hand
should be examined. The tourniquet should be retied on the forearm. Because the veins in
these areas are smaller, it may be necessary to change equipment and use a smaller needle
with a syringe, a winged blood collection set.
• When a patient is receiving IV fluids, blood should be drawn from the other arm.
Whenever possible, areas near the site of a previous IV should be avoided for 24 to 48
hours. When a patient has IVs in both arms, it is preferable to collect the specimen by
dermal puncture if possible. If an arm containing an IV must be used for specimen
collection, the site selected must be below the IV insertion point and preferably from a
different vein. A nurse may choose to collect blood from an IV line that is inserted into the
vein. The IV should be turned off for at least 2 minutes and the first 5 ml of blood drawn
must be discarded because it may be contaminated with IV fluid.
 Dermal Puncture
• Dermal puncture is the method of choice for collecting blood from infants and children
younger than 2 years of age. Locating superficial veins large enough to accept even a
smallgauge needle is difficult in these patients, and veins that are available may need to be
reserved for IV therapy. Use of deep veins, such as the femoral vein, can be dangerous and
may cause complications including cardiac arrest, venous thrombosis, hemorrhage, damage
to surrounding tissue and organs, infection, reflex arteriospasm (which can possibly result
in gangrene), and injury caused by restraining the child. Drawing excessive amounts of
blood from premature and small infants can rapidly cause anemia, because a 2-lb infant
may have a total blood volume of only 150 mL Dermal puncture is the method of choice
for collecting blood from infants and children younger than 2 years of age. In adults,
dermal puncture may be required for a variety of reasons, including:
1. Burned or scarred patients
2. Patients receiving chemotherapy who require frequent tests and whose veins must be reserved
for therapy
3. Patients with thrombotic tendencies
4. Geriatric or other patients with very fragile veins
5. Patients with inaccessible veins
6. Home glucose monitoring and point-of-care testing
 Patient Preparation
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• For optimum blood flow, the area to be punctured should be warm. This is primarily a
concern for patients with very cold or cyanotic fingers, for heel sticks to collect multiple
samples, and for the collection of capillary blood gases. Warming dilates the blood vessels
and increases arterial blood flow. Warming is performed by moistening a towel with warm
water (42°C) or by activating a commercial heel warmer and covering the site for 3 to 5
minutes.
DERMAL PUNCTURE SITES
1. Use the medial and lateral areas of the plantar surface of the heel.
2. Use the central fleshy area of the third or fourth fingers.
3. Do not use the fingers on the side of a mastectomy.
4. Do not use the back of the heel.
5. Do not use the arch of the foot.
6. Do not puncture through old sites.
7. Do not use areas with visible damage.
 Cleanse the Site

• After the vein is located, release the tourniquet and cleanse the site using a spirit/alcohol
swab.
• Use a circular motion starting at the inside of the venipuncture site and work outward in
widening concentric circles
• For maximum bacteriostatic action to occur, the spirit/alcohol should be allowed to dry for
30 to 60 seconds. Performing a venipuncture before the alcohol has dried causes a stinging
sensation for the patient and may hemolyze the specimen.
• Do not reintroduce contaminants by blowing on the site, fanning the area, drying the site
with unsterile gauze, or touching the site after cleansing it.
• If additional palpation of the vein is needed after the cleansing process, the phlebotomist
should use alcohol to cleanse the gloved end of the finger to be used and touch only above
or below the needle insertion point.
• Blood cultures and arterial blood gases require that the site be cleansed with an antiseptic
stronger than isopropyl alcohol. The most frequently used solutions are povidone-iodine.
 Examine and Assemble Puncture Equipment

• While the alcohol is drying, make a final survey of the supplies at hand to be sure
everything required for the procedure is present, and assemble the equipment.
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 Perform the Venipuncture

• Reapply the tourniquet and confirm the puncture site. If necessary, cleanse the gloved
palpating finger for additional vein palpation. Ask the patient to again make a fist.
• The needle & syringe is held securely in the dominant hand with the thumb on top and the
other fingers below. Before entering the vein, remove the needle’s plastic cap and visually
examine the point of the needle for any defects, such as a nonpointed or rough (barbed)
end.
• Position the needle for entry into the vein with the bevel facing up.
• Use the thumb of the nondominant hand to anchor the selected vein while inserting the
needle
• Place the thumb 1 or 2 inches below and slightly to the side of the insertion site, and the
four fingers on the back of the arm and pull the skin taut.
• As mentioned previously, the median cubital vein is the easiest to anchor and the basilic
vein is the most difficult. In general, the closer a vein is to the surface, the more likely it is
to roll.
• When the vein is securely anchored, align the needle with the vein and insert it, bevel up, at
an angle of 15 to 30 degrees depending on the depth of the vein. It should be done in a
smooth quick movement so the patient feels the stick only briefly.
• Once the vein has been entered, the plunger of the syringe is pulled back to fill the syringe.
Once blood begins to enter the syringe the tourniquet can be released.
• Ask the patient to relax his or her fist.
 Remove the Needle

• Before removing the needle, remove the tourniquet by pulling on the free end. Failure to
remove the tourniquet before removing the needle may produce a hematoma. Place the dry
cotton swab over the venipuncture site, smoothly withdraw the needle, and apply pressure
to the site as soon as the needle is withdrawn.
• Blood from the syringe is evacuated into various tubes, Tubes should be held at a
downward angle while they are being filled. Follow the prescribed order of draw when
multiple tubes are being collected, and allow the tubes to fill up to the desired level. Mixing
of evacuated tubes by gentle inversion 3 to 8 times depending on the anticoagulant or
additive should be done as soon as possible.
• Delay in mixing the specimen may cause clots to form and necessitate recollecting the
specimen.
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 Dispose of the Contaminated Needle

• On completion of the venipuncture, the contaminated needle is cut using needle cutter and
discarded in sharp container & syringe is discarded in blue bin.. Under no circumstance
should the needle be bent, placed on a counter or bed, manually recapped, or removed from
the syringe after use.
 Thank the Patient

• Patients should be thanked for their cooperation in both inpatient and outpatient settings.
Leave the patient’s room in the condition in which you found it (bed and bedrails in the
same position).
 Deliver Specimens to the Laboratory

• Transport the specimens from the OPD collection room in designated containers as soon as
possible. Gently transport specimens in a vertical position to facilitate clotting and prevent
hemolysis.
7.3 Specimen Processing

• The stability of analytes varies greatly, as do the accepted methods of preservation. This is why
rapid delivery to the laboratory or following laboratory prescribed specimen handling protocols is
essential.
• Common protocols include separation of the plasma or serum from the cells, storage temperature,
and protecting the specimen from exposure to light.
• The CLSI recommends centrifugation of tubes and the separation of plasma or serum from the
cells within 2 hours. Ideally, the specimen should reach the laboratory within 45 minutes and be
centrifuged on arrival.
• Tests most frequently affected by improper processing include glucose, potassium, and coagulation
tests. Glycolysis caused by the use of glucose in cellular metabolism causes falsely lower glucose
values. Hemolysis and leakage of intracellular potassium into the serum or plasma falsely elevates
potassium results. Coagulation factors are very labile, therefore, for optimal results; specimens for
coagulation testing should be delivered to the laboratory for testing within 1⁄2 hour of collection.
• According to the CLSI guidelines, coagulation specimens for activated partial thromboplastin
times (APTTs) are stable at room temperature for 4 hours unless the patient is on heparin, in which
case, the plasma must be removed from the cells within 1 hour after collection and tested within 4
hours. Specimens for prothrombin time (PT) testing are stable for 24 hours at room temperature.
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All other coagulation tests must be performed with 4 hours of collection. When samples cannot be
assayed within the required time frame, the plasma must be separated from the red cells and frozen
within 1 hour of collection.
• The venipuncture procedure is complete when the specimen is delivered to the laboratory in
satisfactory condition and all appropriate paperwork has been completed.
 Causes of Specimen Rejection
Specimens brought to the laboratory may be rejected if conditions are present that would compromise
the validity of the test results.
Major reasons for specimen rejection are the following:
1. Unlabeled or mislabeled specimens
2. Inadequate volume
3. Collection in the wrong tube
4. Hemolysis
5. Lipemia
6. Clotted blood in an anticoagulant tube
7. Improper handling during transport, such as not chilling the specimen
8. Specimens without a requisition form
9. Contaminated specimen containers
10. Delays in processing the specimen
7.4 Safe handling of specimens:
• Specimens should be collected in sturdy containers with adequate closure to prevent spillage or
leakage. All specimens must be considered a potential hazard.
• Use racks or trays to transport sample bottles, tubes and glassware. Large containers shall be
provided with suitable jackets or cartons for carrying.
• If a sample shows evidence of breakage, leakage or soiling on outside of a specimen container,
put on gloves and transfer as much of the specimen as possible to a second container. Also
rewrite any pertinent information from the old onto the new container.
• Do not keep samples on requisition forms.
• Blood-contaminated specimen requisition forms should be rejected. Handle such a requisition
only with gloves if processing is necessary in an emergency. Notify the requestor that such
contaminated materials present a health hazard.
• Splashes and aerosols can only be avoided or minimized by good laboratory techniques. Blood
and serum should be pipetted carefully, not poured.
• Pipetting by mouth of any material is absolutely prohibited. A variety of suitable pipetting aids
are available.
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• Always use exhaust hoods when working with specimens for Microbiological analysis.
• Wash hands thoroughly with soap and water several times a day and, particularly, after
handling specimens & before leaving for food or drinks.
7.5 Treatment & Disposal of Biomedical Waste

• Segregate all biomedical waste according to their type and dispose them in color-coded bags as
per Biomedical waste management rules 2018
• OCHRI has solicited the services of one private agency, Superb Hygienic Disposals for
treatment of all waste generated in OCLS laboratory
• The function of this agency include removing all waste from the premises of OCHRI.,
NAGPUR on a daily basis between 8.00 a.m to 10.00 a m while the house keeping staff of the
hospital is responsible for segregating all waste of Pathology Laboratory and transporting the
same to waste collection area.
8.1 Policy: Reporting of critical values has to be done in order to initiate treatment as early as
possible depending upon criticality.
8.2 Responsibility: HOD, Technicians, Nursing staff, RMO’s, Treating consultant
8.3 Procedure:
1. Critical value observed in Laboratory
2. Critical values noted in Indoor patient register and highlighted by yellow
highlighter for easy identification along with the following details:
• Patient name
• IPD no.
• Critical values
• Informed to
• Reporting time
3. Such values are informed to RMO and Intensivist of respective wards by
Laboratory staff
4. Critical values are entered in investigation chart and highlighted.
5. RMO’s and Intensivist inform such values to the treating consultant and actions
are taken as ordered by consultant.
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8.4 Following are the critical values and turnaround time accepted hospital wide:
HAEMATOLOGY
Sr. Critical TAT
Parameter Units Biological Ref Interval
No Range (HRS)
M: 13-18 gm%,
1 Hemoglobin G% <6,>19 6
F: 12-16 gm%
40-50% (M),
2 HCT/PCV % 6
35-52 % (F)
Total Leucocyte <2000 & >
3 / c mm 4000 -11,000 6
count 30,000
Polymorphs 40-80%
Absolute 1200 – 6800/c mm
Eosinophils 1-6%
Absolute 40-240/c mm
% Basophils 0-1% Absolute Immature cells
4 Differential Count 6
c mm 40-40/c mm present
Lymphocytes 20-40%,
Absolute 1200 – 3200/c mm
Monocyte 2-10%
Absolute 160-400/c mm
<50,000 & >
5 Platelet Count /cu.mm 150000 – 450000 6
7,00,000
6 RBC million/cmm 4.8 – 5.6 <2 & > 7.5 6
7 MCV µm3 76-94 6
8 MCH pg 25 – 34 6
9 MCHC g/dl 30 – 36 6
10 RDW % 10.6 – 15.7 6
11 MPV µm3 6.5 – 11.0 6
12 PDW % 10.0 – 18.0 6
13 Bleeding Time minutes 1 – 5 min >10 minutes 4
14 Clotting Time minutes 5-11 min >13 minutes 4
> 1.6 (Not on
Prothrombin Time PT: 12 seconds
15 seconds treatment) >2.5 4
(PT) INR: 1.2
(On treatment
16 APTT seconds 32 seconds >80 seconds 4
BIOCHEMISTRY
Sr. Critical TAT
Parameter Units Reference Interval
No Range (HRS)
Fasting: 60-110 <50
1 Glucose mg/dl 6
Post – prandial: 90 -160 >500
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Random: 60 -140
2 Blood Urea mg/dl 10-40 >90 6
Male 0.4 – 1.4
3 S. Creatinine mg/dl >3 6
Female 0.4 – 1.4
4 S. Sodium m eq/L 135-148 <115, >160.0 4
5 S. Potassium m eq/L 3.5 – 5.3 <3.0,>6.0 4
6 S. Chloride m eq/L 87-118 <80,>120 4
7 Ionic Calcium m mol/L 0.82 – 1.22 m mol/L <0.6,>1.6 4
8 Total Bilirubin mg/dl 0.2 – 1.2 >15 6
9 Direct Bilirubin mg/dl 0-0.3 >15 6
10 Indirect Bilirubin mg/dl 0.2 – 0.9 6
11 Total Protein G/dl 6.6 – 8.3 <3 6
12 Sr. Albumin G/dl 4.0-6.0 <1.5 6
13 Sr. Globulin G/dl 2.4 – 3.0 <1.0 6
14 Sr. SGOT /AST U/L Upto 45 >1000 6
15 Sr. SGPT/ALT U/L Upto 45 >1000 6
Sr. Alkaline Male: 0-270
16 U/L >800 6
Phosphatase Female: 0-240
<7.0 and
17 Total Calcium mg/dl 8.7 -11.0 6
>12.0
Male: 3.5 – 7.0
18 Uric Acid mg/dl >12 6
Female: 2.5 -6.0
Male: 25 - 170
19 CK NAC U/L >500 6
Female: 25 - 170
More than
20 CK MB U/L Up to 5.9 2
5.9
21 S. Cholesterol mg/dl 150-200 >400 6
22 HDL mg/dl 40-70 6
23 S. Triglycerides mg/dl Upto 170 >1000 6
24 Amylase mg/dl Up to 85 >900 6
25 Lipase u/L Up to 190 u/L >700 6
Non-diabetic – 4.2 - 6.2
Good control – 5.5 -6.8
26 HbA1C gm% 6
Fair control – 6.8-7.6
Poor control- 7.6
27 Iron u mol/L 59-158 8
28 TIBC u mol/L 250-400 8
29 LDH U/L 230-480 6
30 Lactate m/mol/L 4.5-20.0 2
31 Cholinesterase U/L 4900 – 11900 2
32 G6PD u/gHb 4.6 – 13.5 6
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33 PO4 mg/dl 2.7 – 4.5 6

34 D-Dimer ng/ml More than 500 2
35 RA u/L Up to 30 6
36 ASO IU/ml Positive, Negative 6
30 - 40 Suspected
40 - 60 strong
37 ADA U/L 6
suspected
More than 60+
CLINICAL PATHOLOGY
Sr. Reference Critical TAT
No Parameter Units Interval range HRS
Positive 6
for occult
Stool blood,
1 Examination NA NA C. Vibrio 2
Sugar +++
+, Protein
2 Urine NA NA ++++ 6
Sputum ZN AFB
3 staining NA NA positive 6
9.0 Policy: The laboratory has identified the situation where the report has to be recalled/
withheld. Such situation arises wherever:
• Any nonconformity is detected which is relevant to patient care or QMS of the laboratory.
• Malfunctioning of equipment is detected
• Errors in sample collection/ processing/testing/quality control is/are detected
Under such situation the report will be withheld/ recalled and all stake holders will be intimated.
9.1 Purpose: To lay down procedure for recalling/ withholding/ release of reports.
9.2 Responsibility: HOD Laboratory and Technician Incharge
9.3 Procedure:
• The HOD Lab. Links the test with the request form and identifies patient/ clinician/HCO
• The HOD carries out a preliminary verification of the error.
• The HOD arranges to label the equipment as “UNDER VERIFICATION” and stops all tests
with the equipment.
• Arranges to call the concerned clinician/ HCO or patient and informs him about the suspected
result and requests recall/withholding of results.
• Verifies the cause of error and takes corrective action.
• Recalibrate the equipment and / or substitutes the reagent.
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• Verifies results.
• Conduct retest from the stored primary sample if available.
• Verifies the results.
• Releases the fresh results
• Records the incident as sentinel event.
• Removes the label and release orders for reuse of the equipment.
• Maintain records of such occurrence in redo and reporting error register.
10.0 Policy: The laboratory has established procedure for revised report.
The laboratory recognises that such situation may arise due to:
Pre-analytical:
• Wrong Patient Identifiers
• Inadequate sample
Analytical:
• Malfunctioning of a particular equipment
• When interim calibration / maintenance of equipment is required.
Post-analytical:
• When there is inadequacy of staff mainly the advisory staff.
• Typographical error
10.1 Responsibility: The HOD Lab is responsible for taking necessary action as appended below.
10.3 Procedure:
• The laboratory technician in-charge of the process shall report to the HOD Lab/ consultant
pathologist immediately.
• The HOD Lab shall verify the state and identify the root cause.
• The HOD Lab shall determine the time frame within which the rectification could be achieved.
• Technician Incharge shall call out the original report and inform about the error to concerned
people (Consultant, Nursing staff and patient in case of OPD )
• Realistic time frame for the result/conduct of test shall be intimated.
• Take corrective / preventive actions where applicable.
• Intimate the concerned people of the revised result.
• Revised report is sent to concerned people In the revised report format original value and
corrected value is mentioned.
• Maintain records of such occurrence in redo and reporting error register.
11.Policy: To establish a procedure for handling of outsourced tests.
11.1 SCOPE
11.1.1 Applicable to all investigations not performed in our laboratory and/or for tests that may be sent
to outside labs in case of equipment breakdown and/or any other reason.
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11.2. RESPONSIBILITY: Pathologist, Microbiologist, Lab Technicians.
11.3 PROCEDURE
11.3.1 Pathologist and Microbiologist are responsible for identifying and controlling the outsourced
activities. The criteria for selection of a lab for outsourcing the tests are as under:
a) Accreditation status of the laboratory
b) Turnaround time of tests
c) Cost effectiveness
d) Facility for pick up of samples and delivery of reports
11.3.2 Performance monitoring criteria are as under:

a) Frequency is monthly
b) Quality of result is ascertained based on
I. Test report content
II. Correlation with clinical features
c) Complaints if any
d) Adherence to turn around time
e) Review by in–house Pathologist or Lab Incharge
11.3.3 Re – evaluation is performed once a year. It is based on criteria of selection and performance
11.3.4 The outsource register maintained as per the format bearing the code, the details of the sample
received like patient name, IP. No/ MRN no., date, lab serial no, Tests required are noted.
11.3.4 Sample pick up is undertaken by the outsourced laboratory twice a day and delivery of reports
at the earliest. List of approved out sourced Labs:
SRL Diagnostics FDP Dhruv Pathology
Vitamin B 12 Urine Metanephrines HIV Elisa
Homocystin Level Urine Myoglobin Gama- GT
Anti TPO Hepatitis E CA 19.9
Serum AMH TTG/ DGP Direct & Indirect Coombs Test
Serum Prolactin Alpha-Fetoprotien Chloride
HAV IgM CA 19.9 Chikungunia
HEV IgM HSV PCR Sr. Cortisol
Insulin ER-PR-HER 2 Insulin
Testosterone Auto Immuno Pannel CEA
ANA Profile Anti CCP HBSAg Elisa
ANCA FSH Urine Chloride
HB Electrophoresis Immuno Histo Chemistry (IHC) Scrub Typhus
Free T3 Urine for Toxicology Venous Blood Gas
Free T4 HSV IG G Blood Bacted C/S
ANA by IFCEA Level HSV Ig M Bal
Gene Expert Cepto IgM Antibody MIC
TT secretion HBV DNA Viral Load Biological Indicator
C3 Count C4 Count Double marker
Triple Marker
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/Ver. No 4/ Rev 00
Page 24 of 24

AAC 6 Lab Services Policy

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AAC 6 Lab Services Policy

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Hospital Policy Manual Laboratory Services

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

Laboratory Services Manual

ORANGE CITY HOSPITAL AND RESEARCH INSTITUTE,

Review By: Approved By: Issued By:

Name: Name: Name:

Lab Director Vice-Chairperson QA Head

Signature Signature Signature

Date: Date: Date:

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

CONTROL OF THE MANUAL

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

S.No. Section no & Details of the Reasons Signature of Signature of

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

5.0 Department Overview

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

5.3Facilities and Equipment –

5.3 Tests offered –

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

Serum Creatinine Pleural Fluid for Cytology Sickle Cell Test

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

Urinary Copper Urine for Hemoglobinuria

Records Description Location Retention

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

• Patient’s name and identification number (M.R.no)

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

7.2 Collection, Identification and Transportation:

 Identify the Patient

 Prepare and Position the Patient

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

 Different blood collection tubes are as under:

 Label the Tubes

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

 Wash Hands and Wear Gloves

 Apply the Tourniquet

 Select the Venipuncture Site

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

 Cleanse the Site

 Examine and Assemble Puncture Equipment

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

 Perform the Venipuncture

 Remove the Needle

NABH Standard Reference: AAC 6

Issue Date: 1 January 2023 NABH/AAC/Laboratory Services

 Dispose of the Contaminated Needle

 Thank the Patient