Microbiology Laboratory Incident Standard Operating Procedure (SOP)

1.0 Objective

To lay down a procedure for Logging, investigating, reporting and disposing of Microbiology Laboratory Incidents.

2.0 Scope

This procedure is applicable for all the laboratory incidents logged in Microbiology.

3.0 Responsibility

• Officer and above – Microbiologist: Responsible for logging and initiating the Laboratory incidents.
• Section in-charge- Microbiology: Responsible for investigation, proposal of corrective, preventive actions, establishing the results and its conclusion.
• Head or responsible- Microbiologist: Responsible for disposition of Laboratory incidents.

4.0 Accountability

Head/designee- Microbiology.

5.0 Procedure

5.1 General Definitions

Incident: An incident can be defined as unplanned or uncontrolled event in the form of non-compliance to the designed system or procedures at any stage during receipts, storage, handling, disposal and analysis of samples due to system failure, environmental variations, procedural errors or equipment break down or manual error.

5.2 Incidents are of two types

1. Quality Impacting Incident (Deviation): Those occurrences/errors reported during execution of activity, which may affect the Quality, Safety, Efficacy and strength of the product/material or documents with departure from a written and approved procedures or an established standard.
2. Quality Non-Impacting Incident (Incidents and LIR): Those occurrences/errors reported during execution of activity, which may have no impact on the quality, safety, efficacy and strength of the product/material.

5.2.3 Typical examples of quality non-impacting incidents are as follows:

• Sequential number allotment for the media preparation or autoclave serial number.
• Allotting A.R. No in sequential order.
• Spillage of media while testing or plate preparation.
• Spillage of samples.
• Disturbances such as:
  • Power failures/UPS break down /Network and software connectivity issues.
  • Differential pressure less by 2 Pascal from the limit up to 1 hour in non-critical areas.
  • Temperature deviations from specified limits up to 24 hours in microbial testing area or in Microbiology laboratory.
• Errors such as not limited to:
  • Improper selection of STP / SOP / GTP / media / materials / chemicals / cultures and Methods.
  • Dilution errors in solution preparation.
  • Obvious errors in calculation / integration and interpretation of results.
  • Wrong interpretation of test results.

5.3 Logging of LIR & Investigation

• Upon identification of an LIR, the analyst shall immediately notify to the Laboratory supervisor whenever the event is occurred.
• Head of the Department/ Designee along with analyst shall evaluate impact of the event on the Quality, Safety and efficacy of the product and severity on laboratory functioning.
• Analyst shall fill the relevant details in the header of the Incident report form based on the event occurrence and handover to Head of the Department/ Designee.

5.4 Numbering of Laboratory Investigation report (LIR)

• Laboratory Investigation report (LIR) number is a sequential number issued for the evaluation of incident occurred in the laboratory.
• Each Laboratory Investigation report shall have unique identification number shall be allotted a sequence number of thirteen characters as follows:
  • The first three characters are alphabets indicating “LIR”.
  • Fourth is slash “/”.
  • Fifth and sixth characters are alphabetical indicating department code “MB”.
  • Seventh is slash “/”
  • The 8th and 9th characters are last two numeric numbers of the current running year. E.g. For the year 2023, it will be 23 and for the year 2023, it will be 23 and so on.
  • Tenth is slash “/”
  • The last four characters are numerical in sequential order starting from 001 every year.
  • Example: The first LIR filed in Microbiology for the year 2023 shall be numbered as LIR/MB/23/0001.
• Laboratory supervisor is responsible for assigning the number for LIR in Annexure – 01 (Format No: FMT/MB/198).
  • Note: In absence of Laboratory supervisor analyst can initiate the LIR.

5.5 LIR Investigation, closing and disposition of incidents

• If any LIR is happened during the on-going activity, concern analyst or observer shall be immediately informed to the Laboratory supervisor.
• Laboratory supervisor shall verify the details of event and allot the Laboratory Investigation Report (LIR) number. Analyst shall write the Brief Description of LIR in Annexure-02.
• After the LIR is logged, Laboratory supervisor shall verify the root cause of the event occurrence and immediate corrective action can be proposed. Same shall be informed to Head of Department/ Designee and documented in the space provided under immediate action column in Annexure-02.
• It shall be closed by Laboratory supervisor/Section In-charge and the same shall be verified by HOD or designee.
• The supervisor and analyst together shall investigate the probable reasons liable for any incidents.
• After evaluation, the raw data of Quality non-impacting incidents shall be disregarded and proceeded for fresh analysis.
• Quality non-impacting incidents shall be addressed predominantly through the trainings and maintenance of instruments.
• Head-Microbiology or his designee shall evaluate and investigate the incident.
• Based on the investigation / evaluation, shall propose and implement the corrective and preventive actions.
• Investigation and implementation of the corrective actions shall be completed in maximum 30 working days.
• Microbiology Head / Designee and QA Head / Designee shall together investigate, evaluate and dispose the quality impacting incidents.
• All relevant data with respect to the incident shall be preserved for reference.
• If necessary, Laboratory supervisor shall recommend re-training to the analyst in that technique or event.

6.0 Abbreviations

7.0 References

Nil

8.0 Annexures

Annexure-01: Laboratory investigation report number

Annexure-02: Laboratory Investigation Report (LIR)