Audit Checklist For Microbiology Laboratory

Laboratory audits ensure that laboratories have quality systems in place and adhere to standard laboratory practices. A successful audit requires adequate preparation, accurate performance, insightful reporting, and productive follow-up.

Audit checklists help auditors gather evidence that laboratory processes meet ISO 9001 standards. They contain questions taken directly from quality management system requirements and work performance criteria relevant to each process being audited.

1. Equipment Maintenance Plan
Laboratory equipment requires regular maintenance plans in order to stay in good working order, which includes both preventive and corrective maintenance measures. Preventive Maintenance (PM) should be conducted routinely as it’s more cost-effective; PM can involve cleaning, inspections, repairs and replacing parts as required.

Staff should conduct an internal audit using a checklist at least annually, to help prepare their lab for external audits and identify critical non-conformities that could have serious repercussions.

A laboratory should establish and implement a Chemical Hygiene Plan which details safety information, working procedures for particularly dangerous materials, fume hoods and ventilation needs, as well as fire safety and sprinkler systems in case of emergencies.

2. Sample Receiving
All lab personnel should possess the required competencies for performing microbiology testing. Achieving competency can be determined through specific course work, practical experience and accreditation certifications.

Receiving specimens is a key step in laboratory operations. Samples should be received in containers suitable for their intended test; urine specimens should be submitted using preservative tubes rather than sterile cups, while transport media has been created specifically to improve culture results and facilitate downstream automation.

As part of an effective process, it is also necessary to implement procedures for handling verbal requests and verifying the correct specimen volume requested, to ensure tests can be run as scheduled and samples don’t go to waste. signNow offers various security measures designed to make forms fill out legally and safely while meeting compliance with ESIGN, UETA, and eIDAS – key legal frameworks pertaining to electronic signatures.

3. Analytical Methods
Microbiological testing of products is an essential task in many industries, from food and pharmaceutical production to medical devices and biofuel production. By identifying or enumerating microorganisms, these analyses allow for their detection or elimination, helping prevent spoilage in food products while assuring quality assurance of pharmaceuticals and medical devices, as well as aiding production of natural antibiotics, solvents, preservatives or biofuels.

Select analytical methods which are tailored specifically to the type of sample being studied. A successful technique should be sensitive, selective, quantitative and reproducible.

An audit checklist is a series of questions designed for use by auditors to verify whether laboratory processes meet a specified requirement, for example ISO 9001 standards compliance. If nonconformances occur during audit, an auditor will report them immediately.

4. Analytical Controls
Microbiology laboratories play an essential role in the diagnosis, treatment and monitoring of hospital acquired infections. Their compliance with ISO 9001 requirements should include document control, training of personnel to meet qualification standards for biosafety precautions as well as facilities, equipment, reagents as well as recording test results recording and reporting requirements.

The laboratory must also provide daily reports detailing significant microbiology findings categorized by ward, pathogen and source of infection. Furthermore, the microbiology laboratory is required to monitor and report on select pathogens known to have high epidemic potential such as MRSA, VRE, extended spectrum-lactamase producing Enterobacteriaceae and Acinetobacter baumannii.

Failing to perform tests accurately and reliably can have serious repercussions for patient health, drug shortages and regulatory fines or recalls. To ensure quality analytical methods are used by lab, an internal quality control procedure with well-defined culture collections or isolates used for antibiotic susceptibility/sterility testing along with negative controls is vitally important.

5. Reporting
Reporting is one of the cornerstones of microbiology lab work. It forms the basis for surveillance, outbreak detection, patient safety and antimicrobial stewardship programs as well as comparison (“fingerprinting” or “typing”) between epidemiologically related isolates – an essential step in outbreak investigation processes.

Reporting allows a baseline incidence to be established, which makes comparing any new isolates easier and early outbreak detection more likely (Kalenic et al., 2019). As such, implementation of this checklist is crucial to improving scientific reporting, increasing data utility for surveillance purposes, grading data quality assessments, supporting meta-analyses, as well as informing policy and interventions from local to global levels.