LABORATORY

Standard operating procedures

Sample acquisition and receipt
Outpatient services
The doctor orders the different tests in response to a lab request. After receiving the request form, the lab
officer checks the details. The automated lab registration is assigned by the lab technician.
The specimen collection procedure begins after successful verification of the patient.
Lab officer initiates the testing procedure by placing a label and transports in a testing area.
After sorting the specimens into different testing sections, the lab worker begins testing the samples. The
lab officer enters the information about the samples they have received into the appropriate records for
ease of access incase of reference.

Inpatient services
The patient's information is labeled on the sample test tube, which the lab officer or nurse obtains and
sends to the lab along with the lab request form.
The lab officer keeps track of every detail regarding the samples they receive in the appropriate registers.
The laboratory officer is responsible for all activities done in the lab

The process for identifying and labeling samples

Sample's name, age, sex, and ward are used to identify it. Empty containers are brought into the wards,
and the nursing staff fills them in, noting the patient's name, age, location, ID number, and the
investigations that need to be done.

The technicians gather the outpatient department samples in the sample collection area. patient sample
collected in accordance with established laboratory procedures. The patient is advised of when the reports
can be picked up.
All specimens are properly tagged with the type of sample, patient name, and identification number
number before being stored in the appropriate laboratory repository/trays.
Depending on the analyte's constancy, samples for tests that are contracted out to other labs are sent in
their original vials, and the specimen is kept at the proper temperature until it is received by the referral
lab.
Protocol for managing and transporting primary samples, including guidelines for temperature,
duration, and the carrier
Every sample has a label that includes the patient's name, sample identification number, kind of sample,
and patient type (Inpatient or Outpatient).
If the patient type is IP, the label also includes information about the particular ward where the sample
was obtained.
The sample is returned to the appropriate location where it was collected if it's properly labeled.
Glass tubes are used to move samples in closed tube s/containers from the designated collecting location
to the main laboratory area. The samples are transported according to test requirements and arrive at the
testing lab in around 20 to 30 minutes from the collection station.
Technicians who handle patient samples put on gloves while working with the samples to ensure there is
adherence to occupational safety rules and regulation.

Acceptance and rejection practices for primary samples

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In order to save valuable time and money, it is intended to specify the circumstances in which the
specimens are rejected prior to the commencement of the investigation and a repeat sample is requested.
After samples are received by the testing laboratory, they are examined for the following: patient
diagnosis, information regarding demographics, laboratory test request form, quantity and quality of
sample, suitable container, and mode of temperature.

Rejection Standard/ Criteria

i Samples that are received in expired tubes.

ii Duplicate samples
iii Leaky containers
iv Inappropriate sample sources.
v The amount of time that has passed between sample collection and processing is greater than
what is allowed given the specimen's real storage conditions.

vi Blood taken for serum biochemistry testing in simple bottles i.e. specimens that are murky, which
suggests inadequate preservation, Haemolyzed specimens, non-clotting blood. Sample gathered
in a vial of EDTA, citrate, or glucose
vii Ethylenediaminetetraacetic acid (EDTA) blood i.e. Fluid exhibiting hemolysis or clot formation,
as well as blood exhibiting a volume increase or drop of more than 20%
viii Unfinished or incorrectly labeled specimen i.e. the main sample is first processed if it is
irreplaceable or crucial, but the report is not made public until the doctor who made the request or
the individual in charge of gathering the primary sample accepts responsibility for locating and
accepting the sample or for giving accurate information.
ix Unlabeled and illegible sample form all collected specimens

x Inconsistency between the patient's name on the test order and the specimen

xi Wrong packaging and storage

xii Inadequate quantities of sample

Method for handling the main sample

Samples are handled in accordance with the instructions found in the lab's (Laboratory Operations
Manual). When handling and processing patient specimens, cleaning, and decontaminating equipment,
staff always wears gloves and lab coats, or aprons to enhance your own safety.
Semen examination detailed instructions should be followed before the semen is obtained.
It is advised to abstain for three days.

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To accept the sample in accordance with the first point's instructions
to do a physical assessment to determine the sperm count, motility, structure, color, pH, liquefaction time,
thickness, and volume.

Urine Newly produced specimens are ideal. To avoid bacterial contamination, samples are chilled during
testing or transportation disruptions. For samples, to utilize Multistix or Uristix strips. Any irregularity
found must be verified using standard techniques, such as the heat acid test, proteins, etc.
Patients should be provided specific instructions on how to collect urine proteins every 24 hours. The
patient receives a container along with the necessary instructions. Other than the container provided by
the lab, urine is collected in any other container.

Body fluids cerebrospinal fluid, peritoneal, pleural, and pericardial. Under rigorous aseptic conditions,
these are collected by lab officer on duty in PLAIN along with the EDTA tubing and sent straight to the
lab.

Stool It is better to use a fresh specimen. Physical, chemical, and microscopic examinations are all part of
routine analysis. These include color, consistency, pH, occult blood, blood or mucus if present, and
microscopic inspection for cysts and eggs. Under appropriate circumstances, the lab will provide
concentration techniques for microscopic examination to check for cysts and ova.
Requisition of Repeat test
The required lab test is tested from the provided sample upon request if the treating physician considers
that the lab result does not support the clinical diagnosis or if the testing technician believes that the
report may represent an analytical failure.
Critical results reporting

A significant test result is one that falls outside of the normal range and has a high likelihood of causing a
noticeable rise in morbidity or mortality in the near future. This type of result calls for quick results
communication so that the best course of action may be determined.
Within 15 minutes of test readiness, the Laboratory Technologist calls or uses an intercom to notify the
ordering physician or their assistant when a critical result is found.
As soon as a critical result is identified, the Laboratory Technologist gets in touch with the ordering
physician or their assistant for the patient from another facility.

If the ordering physician or their assistant is not reached within 15 minutes of test readiness, the
laboratory officer follows the order notification

Order of Notification

Treating / Ordering / On-duty Staff Nurse / Casualty Medical Officer

The ‘read back' approach is used whenever in-patient reports are shared with the staff nurse. At the
moment the results are presented, the person accepts the critical test result and records it before reading it
back to the reporter in full.
When a patient is an outpatient, they are directly informed of the outcome via a phone call or text
message.

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A physical copy of the crucial result is sent to the ordering physician or their assistant in the event of any
applicable communication system failure. The name and qualifications of the individual receiving the
report, together with the delivery time, are recorded by the laboratory technologist.

Reporting
Test are confirmed, typed, checked/signed and recorded in a lab register. The laboratory in charge
approves the records and gives back the report to the patient or the attending clinician.

Reports distribution and collection

Obtained reports are grouped as per departments then reports are entered into the ward's "Report
received" register, and the findings are recorded in the ward patient's investigations register next to the
patient's name.
Authentication of the reagents
Before being used on actual samples, all stains, media, kits, and other items that are used to test the
samples are validated on calibrators, known controls, or known samples. The reports of these validated
reagents are then filed and documented.
Corrective and preventive measures are implemented if deviations from the initial results are detected.

Validation of examination procedure

Specimens are examined using control material that is comparable to the patient sample matrix.
Errors, both random and systematic, are found through quality control. Every day, two tiers of QC
material are used to test each batch of patient samples for a variety of characteristics. Every day, QC data
are recorded, and control charts are kept up to date to ensure that analytical measuring devices are stable.
To confirm the accuracy of test results for which controls and calibration materials are unavailable,
alternative techniques are also employed.

Process of validating the results and its based on the following criteria

I. Medical professionals and experts in microbiology authorize and oversee all laboratory
techniques and operations. Consultants provide input on the test results' clinical value, which is
then examined.

II. Day to day internal quality control

III. Taking part in external quality control program

IV. Upon opening a new kit, internal quality control or the tests included in the kit validate the
results.

Internal quality control

To undertake the quality measurement, a test menu that is suitable and meets patient requirements is
produced.

I. The technical staff receives the proper training and instructions for the test system and patient
specimen collection.

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 II. Phlebotomy is carried out effectively and painlessly for the patient.
Analytical performance is appropriate when analytical processes are used.
Every biochemical test is carried out strictly in compliance with established procedures.
Every quarter, the lab supervisor evaluates the test results. The overall quality control
testing is the responsibility of a designated laboratory personnel.

III. They will conduct the quality control test on their own, and he or she should have the power to
make the required corrections to any errors found during control testing. Every test sample must
have a control set up. For example, reagent control tests must be set up in each plate during
grouping and Rh procedures.
An additional component of quality assurance is the sterility of blood or its component. The
center's use of equipment, plastic bags, anticoagulants, bleeding sets, and needles necessitates a
practical solution to the issue: sterility from quality control methods implemented by
manufacturers. Strict aseptic measures are followed in the lab when cleaning the pheblotomy site
and bleeding donors.

Internal Quality Control by Replicate Tests on "CONTRO for cell counters

To check precision on coagulation analyzers

The goal, accountability, process, idea, approach, and course of action for repeating tests on "controls" as
part of internal quality control are substantially the same as those for automated cell counts.

Below are the minor procedures

The manufacturer provides the designated value. Experience has demonstrated that there is no discernible
variation of more than 5% between the goal values for activated partial thromboplastin time Active
Pharmaceutical Ingredients (APIT) and prothrombin time (PT) and the values supplied by the
manufacturer. Therefore, it is decided that the instrument will be recalibrated if there is a difference of
more than 5% for any given lot between the manufacturer-assigned value and the actual target value
determined by the laboratory.

Coagulation analyzer controls are reliable, and the same batch has been on hand for nearly a year. As a
result, the analysis of the control run for the first 20 days is used to calculate the target value.

The target value for the next lot is determined 20 days before the current batch is likely to get exhausted.

Repeat Testing on Samples Provided by Patients at Hematology Counters

Every day, during the morning and evening shifts, a random sample is selected and processed through
each analyzer.
The table displays the values and variances of the replicate values for TLC, Hb, HCT, MCV, and
platelets.
A deviation of more than ± 2 SD in the replicates indicates that one of the results is out of range. Test the
other sample once more. There's nothing more to do if the difference is adjusted, that is, if it falls between
two standard deviations.

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It is discussed with the pathologist if the difference is greater than 2SD. The chief technician signs the
results every day. A mistake is reported to the pathologist if it continues.

Procedure for External Quality Assurance Program

External Quality Control

Denotes a system in which a laboratory creates a set of procedures and reagents, the output of which is to
be compared with the output of a recognized reference laboratory. Reagents, personnel, and standard
laboratory equipment are all under the relatively good control of both internal and external quality control
systems.
The Lab has a MOU ( memorandum of understanding) with RML(regional medical laboratory) Mehrotra
Lab, Lucknow for EQAS of Haematology and Bio-chemistry tests if available. The Lab sends the report
of control tests and the z score is received and analyzed for corrective and preventive action

System for Storage of examined samples

Establishing and upholding a protocol for keeping the specimens after the investigation is over will allow
for repeat testing, should the patient or attendant request it. Every sample that enters the laboratory must
follow the protocol.
a) Time spent storing the materials for examination If the evaluation is completed in less than two
hours, the specimens can be stored at room temperature. If the anticipated testing duration
exceeds this, it is maintained at 2-80C and complies with the relevant requirements of specific
tests.

b) Storage period of examined specimen

The inspected specimens must be kept for a minimum amount of time as indicated below in
order to be reexamined and/or subjected to additional testing: Clinical Biochemistry: Minimum 1
day, 2–8 degrees Celsius
Complete blood counts in hematology: "Min one day at 28 deg C"
c) Clinical Pathology: Till results are confirmed
Tested the retained sample for the preserved specimen
To confirm the storage circumstances, numbering scheme, and specimen deterioration during
storage, a repeat test is conducted on the specimens that have been preserved.

The occurrence for the repeat test is as follows:

Hematology The stored sample undergoes a monthly repeat test
Biochemistry Samples for five analytes once in a month

Acceptability Criteria: There is a 15% margin of error between the two outcomes.

Procedure for examination by referral laboratories

Samples that are to be outsourced are separated upon receipt, sent to a shared collecting location, and regi
stered in the Referral Lab database. samples divided into groups according to the studies.
Depending on the stability of the analyte to be assessed, samples for tests that are outsourced to other labo
ratories are shipped in their original vials, and the specimen is kept at the proper temperature until it is rec
eived by the referral laboratory. If the lab sends the samples outside If the samples are sent outside, lab

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technician records the reports when available. All communications to the referral laboratories pertaining
to patient details are done by Pathologist or Lab. Technician

Stock Maintaining & Monitoring

Every item must have a stock register, and reorders must be recorded in the stock register whenever neces
sary. The samples are transferred to a lab outside.
List of the items required shall be well informed to the administrative department through indent.

Procedure for Preventive and Breakdown maintenance: As per Policy for Equipment Maintenance.
Schedules for preventive maintenance are created by reviewing the History Card and following manufact
urer recommendations.
In accordance with the maintenance schedule and records, preventive maintenance is performed.
Regular maintenance activity checks are made by the concerned engineer.
Following the conclusion of maintenance (either preventative or breakdown), the user department provide
s the OK report.