The main purpose of a standard operating procedure (SOP) is to:

Make every analyst do a test the same way

Fix the price of each laboratory test

Record each patient's test results

Keep track of reagent stock levels

A wrong result was reported yesterday. Under ISO 15189 practice, it should be corrected by:

An amended report that keeps the original on record

Phoning the doctor, without any new report

Overwriting the result in the register and LIS

Destroying all copies of the first report

Laboratory organization and management

14 Kerala PSC Lab Technician Gr II practice questions on Laboratory organization and management, part of Biochemistry. The first 14 are below; the first 5 with answers and explanations (tap Show answer after you have chosen), the rest in Learn with a free account.

Question 1 · Easy
Which body accredits medical laboratories in India?
1. ANABL
2. BBIS
3. CNABH
4. DCDSCO
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Answer: A · NABL
The National Accreditation Board for Testing and Calibration Laboratories (NABL), a constituent board of the Quality Council of India, accredits medical laboratories. For medical laboratories it assesses against ISO 15189. NABH accredits hospitals and healthcare providers, BIS sets national product standards and CDSCO regulates drugs and medical devices. Accreditation shows that a laboratory's quality system and technical competence have been independently assessed.
- B: BIS (Bureau of Indian Standards) sets product standards.
- C: NABH accredits hospitals and healthcare organisations, not stand-alone laboratories.
- D: CDSCO regulates drugs, cosmetics and medical devices.
Question 2 · Medium
The main purpose of a standard operating procedure (SOP) is to:
1. AFix the price of each laboratory test
2. BMake every analyst do a test the same way
3. CRecord each patient's test results
4. DKeep track of reagent stock levels
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Answer: B · Make every analyst do a test the same way
An SOP is a written, approved, step-by-step instruction for a procedure, from specimen requirements and reagents to calculation, reference ranges and reporting. Following it means every staff member performs the test in the same way, so results are consistent whoever is on duty. SOPs are controlled documents: they are reviewed regularly, and old versions are withdrawn. They are also used to train new staff and are checked during accreditation.
- A: Test prices are an administrative matter, not part of an SOP.
- C: Patient results are recorded in the register or LIS, not in the SOP.
- D: Reagent stock is tracked in an inventory register.
Question 3 · Easy
The international standard for quality and competence of medical laboratories is:
1. AISO 15189
2. BISO 14001
3. CISO 9001
4. DISO/IEC 17025
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Answer: A · ISO 15189
ISO 15189 sets requirements for both the quality management system and the technical competence of medical laboratories, covering the pre-analytical, analytical and post-analytical steps. NABL uses it to accredit medical laboratories in India. ISO/IEC 17025 covers testing and calibration laboratories in general, ISO 9001 is a general quality management standard and ISO 14001 covers environmental management. The current edition is ISO 15189:2022.
- B: ISO 14001 covers environmental management.
- C: ISO 9001 is a general quality management standard for any organisation.
- D: ISO/IEC 17025 covers testing and calibration laboratories in general.
Question 4 · Hard
A laboratory defines turnaround time as receipt in the laboratory to result release. A sample was collected at 9:10, received at 10:40, analysed at 11:00 and released at 11:30. What is the turnaround time?
1. A20 minutes
2. B1 hour 30 minutes
3. C2 hours 20 minutes
4. D50 minutes
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Answer: D · 50 minutes
By the laboratory's definition, the clock starts at receipt (10:40) and stops at release (11:30), so the turnaround time is 50 minutes. Counting from collection (9:10) gives 2 hours 20 minutes, the total turnaround time including transport. The 1 hour 30 minutes from collection to receipt is the transport delay, and 20 minutes is only the wait before analysis. Turnaround time is a common quality indicator, and long delays before receipt point to problems in sample transport.
- A: 20 minutes covers only receipt to analysis.
- B: 1 hour 30 minutes is collection to receipt, the transport delay.
- C: 2 hours 20 minutes counts from collection, which the definition excludes.
Question 5 · Medium
A wrong result was reported yesterday. Under ISO 15189 practice, it should be corrected by:
1. APhoning the doctor, without any new report
2. BOverwriting the result in the register and LIS
3. CAn amended report that keeps the original on record
4. DDestroying all copies of the first report
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Answer: C · An amended report that keeps the original on record
Records must never be erased or overwritten, so that the history of a result can always be traced. The laboratory issues an amended report, clearly marked as a correction, with the date and the name of the person responsible, while the original stays on record. The requesting doctor is informed, especially if patient care may be affected. The error is also logged as a non-conformity and its cause investigated.
- A: A phone call alone leaves the wrong result on the patient's record.
- B: Overwriting destroys the record of what was first reported.
- D: Destroying the original removes the audit trail.
Question 6 · Medium
For a medico-legal blood alcohol sample, the main purpose of the chain-of-custody form is to:
1. ARecord the reference range used for reporting
2. BRecord the patient's consent for the test
3. CRecord everyone who handled the sample and when
4. DRecord the analyser's QC results for the run
Answer and explanation in LearnFree account
Question 7 · Easy
In a laboratory's document hierarchy, the top-level document that states the quality policy and describes the quality system is the:
1. AQuality manual
2. BTest requisition form
3. CInternal QC logbook
4. DStandard operating procedure
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Question 8 · Hard
During an internal audit, the glucose bench copy of the SOP is version 2, but the master list shows version 4 is current. What is the correct action?
1. ALeave it until the next external assessment
2. BKeep both copies at the bench so staff can compare
3. CReplace it with version 4 and record a nonconformity
4. DChange the master list to show version 2
Answer and explanation in LearnFree account
Question 9 · Medium
Action taken to find and remove the root cause of a nonconformity, so that it does not happen again, is called:
1. ACalibration
2. BCorrective action
3. CCorrection
4. DPreventive action
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Question 10 · Easy
On which principle should reagent kits be issued from the laboratory store?
1. AFirst expiry, first out
2. BCheapest kit, first out
3. CLargest pack, first out
4. DLast received, first out
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Question 11 · Medium
Why should the date of opening be written on every reagent bottle when it is first used?
1. AIt replaces the lot number on the label
2. BOpened reagent may expire before the kit date
3. CIt shows the date the kit was manufactured
4. DIt is needed to calculate the test result
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Question 12 · Easy
Hazards, safe handling, storage and first aid for a laboratory chemical are given in its:
1. ASafety data sheet
2. BQuality manual
3. CKit package insert
4. DCalibration certificate
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Question 13 · Easy
In a biochemistry laboratory, an analyser's calibrations, maintenance and breakdowns are recorded in the:
1. AEquipment logbook
2. BStock register
3. CSpecimen register
4. DQuality manual
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Question 14 · Hard
At 7 pm, an outpatient's serum potassium is 6.9 mmol/L, a value on the laboratory's critical list. The sample is not hemolysed and QC is in range. What should the technician do?
1. AHold the report until the morning shift
2. BRelease it in the LIS without any call
3. CAsk for a new sample before reporting
4. DPhone the doctor now and record a read-back
Answer and explanation in LearnFree account

Laboratory organization and management

Which body accredits medical laboratories in India?

The main purpose of a standard operating procedure (SOP) is to:

The international standard for quality and competence of medical laboratories is:

A laboratory defines turnaround time as receipt in the laboratory to result release. A sample was collected at 9:10, received at 10:40, analysed at 11:00 and released at 11:30. What is the turnaround time?

A wrong result was reported yesterday. Under ISO 15189 practice, it should be corrected by:

For a medico-legal blood alcohol sample, the main purpose of the chain-of-custody form is to:

In a laboratory's document hierarchy, the top-level document that states the quality policy and describes the quality system is the:

During an internal audit, the glucose bench copy of the SOP is version 2, but the master list shows version 4 is current. What is the correct action?

Action taken to find and remove the root cause of a nonconformity, so that it does not happen again, is called:

On which principle should reagent kits be issued from the laboratory store?

Why should the date of opening be written on every reagent bottle when it is first used?

Hazards, safe handling, storage and first aid for a laboratory chemical are given in its:

In a biochemistry laboratory, an analyser's calibrations, maintenance and breakdowns are recorded in the:

At 7 pm, an outpatient's serum potassium is 6.9 mmol/L, a value on the laboratory's critical list. The sample is not hemolysed and QC is in range. What should the technician do?