universe84a

Introduction of Quality Assurance in Clinical Microbiology

According to ISO, quality is defined as the totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs. The principal objective of quality assurance is to provide reliable laboratory results in all health care activities and to ensure inter-laboratory comparability of results in clinical laboratories, epidemiological investigations, health surveys, environmental monitoring, medical research, and other public health activities. Thus, all the microbiology work needs to be performed with utmost care to maintain a good standard at every level starting from the patients at one end to the dispatch of the report to the next end. It denotes the system for continuously improving reliability, efficiency, and utilization of the result and service to the patients.

Types Quality Assurance (QA)

Two ways of quality assurance:

1. Internal Quality Assurance:- It means day to day quality assurance system.
2. External Quality Assessment: It means outside agencies sending sets of certain samples for testing regularly.

Objectives of the quality assurance in Clinical Microbiology

• Confirmative diagnosis and appropriate treatment of the patients.
• To improve the quality of the health facility.
• To isolate pathogens of public health importance.

The factor that affects the quality of the works

Many pre-analytical, analytical, and post-analytical factors affect bacteriological works.

1. Specimen selection – The right specimens for the specific disease are requested.
2. Personnel- The trained staffs are necessary for a good microbiological lab.
3. Laboratory organization- The well-organized lab can have a good output. The ventilation, lighting, working space, availability of equipment and reagents, etc. are necessary.
4. Good quality reagents – Availability of quality reagents is also important.
5. Recording and reporting – The trained staff record all the events in the laboratory.

Quality control (QC) commonly used tests-

Care of the equipment

It is particularly to take of the laboratory equipment. A good quality test cannot be performed without proper care of the equipment used.

The equipment needs cleaning using a moist cotton cloth preferably soaked in the disinfectant. Cleaning must be done thoroughly inside the chambers and outside the equipment. Thereafter dried using a dry cloth. The microscopic lines are cleaned every time after use. the cleaning of other parts of the microscope is done by soft tissue paper or soft flamed cloth. Then it should be covered by dust-resistant plastic specially made for that purpose. The microscopes should be kept covered while not in use. The silica gel packets should be kept inside the chambers for the microscope so as to absorb moisture.

Keynotes on Quality Assurance in Clinical Microbiology

• Benefits of a quality assurance program

1. Delivering a quality product or generation of a reliable service
2. Helping the physician establish a proper and rapid diagnosis, thus generating confidence and better health care for the patient
3. Creation of a good reputation for the laboratory
4. Motivation factor for staff to work better
5. Mandatory requirement for accreditation
6. Prevention of legal suits and associated complications
7. Efficient utilization of resources
8. Cost-saving on account of wrong/over/under treatment
9. Assuring the safety of patients, staff, visitors, community, and environment

• Definition of Validation: It is that part of a quality assurance system that evaluates in advance the steps involved in operational procedures or product preparation to ensure quality, effectiveness, and reliability. The laboratory should record the results obtained and the procedure used for the validation.
• Process of validation
  1. Plan and define aims of validation
  2. Develop a protocol for the process of validation
  3. Execute the process and collect data
  4. Compare results against agreed requirements
  5. Consider any other issues: e.g. health and safety
  6. Accept or reject
  7. Document
  8. Implement
  9. Review
• Assessment of quality can be checked by  Man-driven (Internal and External audit) and Material-driven (internal and external quality assessment).
• Inter-laboratory testing and split sample testing are the types of external quality assessment schemes (EQAS).
• Quality Assurance (QA) =  (Quality Control) QC + (Internal quality assessment) IQA+ (external quality assessment)  EQA
•  Quality control (QC) must be practical, achievable, and affordable.
•  Quality assurance (QA) is important in the diagnosis, treatment, and surveillance of infectious diseases and policies regarding the selection and use of antimicrobial drugs
• Trained technical staff and clinical microbiologists are important resource persons in providing the establishment of essential microbiology services.
•  Regular use of standard operating procedures (SOPs) is essential to maintain the quality of results in between laboratories.
  

  Further Readings

   

  1. https://www.banglajol.info/index.php/AKMMCJ/article/view/8163/6107
  2. https://www.researchgate.net/publication/6195315_Quality_assurance_in_microbiology
  3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3624724/
  4. https://www.standardmethods.org/doi/10.2105/SMWW.2882.180
  5. https://en.wikipedia.org/wiki/Quality_assurance
  6. https://www.who.int/ihr/training/laboratory_quality/11_cd_rom_quality_assurance_in_bacteriology_and_immunology_2002.pdf