Introduction: Scope and Definitions, Types of Laboratories Infrastructure Part-1
By Dr. Jayesh Warade | Consultant Biochemistry & Molecular Biology Sr. Quality Manager Meenakshi Labs 2024-11-28
Dr. Jayesh Warade is a Consultant Biochemist and Molecular Biologist at Meenakshi Labs, Madurai. He has over 15 years of experience in clinical laboratory practice. He completed his MBBS (2004) and MD (Biochemistry, 2010) from Indira Gandhi Government Medical College, Nagpur. He has also completed PG Diploma in Hospital and Health Care Management (2009), PG Diploma in Clinical Research Management (2010) and PG Diploma in Endocrinology (2014). He has conducted various training programs on clinical laboratory management.
Looking to enhance your knowledge about GCLP compliance? Explore our comprehensive FAQs on Good Clinical Laboratory Practices (GCLP) as per ICMR 2021 guidelines. These FAQs will provide clear and concise information on the essential aspects of GCLP, including its scope, definitions, and laboratory infrastructure requirements. Whether you are a laboratory professional, researcher, or regulatory expert, you'll find valuable insights to ensure adherence to GCLP standards.
GCLP or Good Clinical Laboratory Practices is a guideline designed to ensure laboratory results' accuracy, reliability, and integrity. They provide a framework for organising and conducting laboratory activities, including planning, performing, monitoring, recording, archiving, and reporting laboratory studies. It was first released in 2008 by the Indian Council of Medical Research to promote uniformity in maintaining the quality of laboratory services. It was revised in 2021 to incorporate guidelines related to clinical research laboratories, which were not part of the earlier 2008 edition.
GCLP is crucial for laboratories for several reasons:
By adhering to GCLP, laboratories uphold high standards for quality assurance.
- It helps streamline laboratory processes from equipment maintenance to workflow management, leading to increased operational efficiency and better use of resources.
- Adherence to GCLP guidelines is a regulatory requirement for laboratories involved in clinical research and patient care.
- GCLP is essential for laboratories to protect patient safety, comply with regulations, enhance their credibility, and foster a culture of continuous improvement.
According to GCLP guidelines, laboratories can be classified into a three-tier structure. These levels correspond to the complexity and scope of diagnostic services they provide. Each tier plays a critical role in maintaining the overall quality and efficiency of public health diagnostics, following GCLP and ICMR guidelines. The different levels of laboratories in GCLP are as follows:
PRIMARY LEVEL LABORATORIES
Primary Health Centres (PHC) are the basic structural and functional units of public health services acting as referral units for SCs and referring cases to CHCs.
SECONDARY LEVEL LABORATORIES
The secondary level of health care essentially includes Community Health Centers (CHCs), constituting the First Referral Units (FRUs) and the Sub-district hospitals. The CHCs act to provide referral health care for cases from PHCs and cases in need of specialist care approaching the centre directly. Sub-district (Sub-divisional) hospitals are below the district and above the block level (CHC) hospitals and act as First Referral Units for the Tehsil/Taluk/Block population in which they are geographically located.
TERTIARY LEVEL LABORATORIES
Laboratories are equipped with advanced diagnostic and investigation facilities to provide tertiary-level health care. These hospitals receive referrals from the primary as well as the secondary levels.Besides these, there are Reference Laboratories, Research Laboratories and Specific Disease Reference Laboratories to provide services for complex and special tests.
Lab infrastructure refers to the essential physical and operational components required to ensure that laboratory activities are conducted in a controlled, safe, and efficient manner. The infrastructure of the laboratory varies with the requirements of the clinical research/services provided by the laboratory, but the basic requirements should meet the regulatory and international standards. The infrastructure of a laboratory directly impacts the quality of research data, efficiency and safety of laboratory workers. The management of the laboratory is responsible for providing adequate resources to staff, to ensure efficient working of a laboratory.
- Proper signage within or outside the facility.
- Essential Health and Safety regulations - use safety signage, as applicable.
- Emergency and Disaster management plan.
- Uninterrupted power supply.Laboratory-grade water for examination purposes.
- Ventilation, environment control & lighting arrangements.Communication facility with referral centres.
- Transport of specimens/samples to referral centres.Lab areas containing carcinogens, radioisotopes, biohazards, and lasers should be properly marked with the appropriate warning signs.
- To avoid cross-contamination the basic infrastructure facilities should have separate designated areas for reception, waiting rooms, microbiological or molecular labs, and spaces handling radioactive materials or biohazards etc.
- Separate storage facilities for specimens, reagents, records etc.
- Restricted Access -Only authorized personnel should have access to the examination area and record-keeping area or information systems.
Measurement error refers to errors that are caused by operators, equipment or procedures during the laboratory process. Bias is the systematic deviation from the true or correct value of a measurement. It's not considered an error because it's not due to any mistakes made by the operator or procedure.
There are two ways to obtain internal quality control samples:
- It can be purchased from commercially available suppliers.
- It can also be prepared in-house but it is properly validated for use and have appropriate stability.
In essence, both options are acceptable, but if you choose to prepare samples in-house, you'll need to conduct additional validation steps.
Measuring range is the capacity of your equipment to measure from minimum concentration to the maximum concentration. Linearity is the actual relation between the values which are measured by your examination method and the observed results. In other words, how well the measured values are directly or inversely proportional to the actual values, and how consistent this relationship remains at different concentrations.
