Good Clinical Laboratory Practices (GCLP) were introduced in 2002 to improve the healthcare system, enhance patient outcomes, and facilitate new discoveries. These are guidelines and a quality system designed to ensure that laboratories involved in cutting-edge research maintain high standards. I have embraced these principles from its inception.
The Australian Society's guidelines have been widely adopted by many organizations, including the World Health Organization (WHO), non-governmental organizations (NGOs), hospitals, and academia.
The healthcare industry is currently undergoing major transformations, with many possibilities in medical research that offer hope for breakthroughs in disease detection, infection control, and identification of emerging viruses such as SARS, influenza, and others. Despite the challenges ahead, the sector is witnessing diverse and interconnected changes in the financing of healthcare services, with the aim of providing new and improved healthcare services.
Key aspects of Good Clinical Laboratory Practice (GCLP):
In modern laboratories, some basic practices include:
- Providing healthcare services.
- Ensuring reliable laboratory results for diagnosis, treatment, purity, and identification of disease cases.
- Achieving quality results in digital laboratories by conducting appropriate tests, accurately documenting the results, and ensuring the integrity of the testing procedures.
- Conduct approved laboratory tests only.
- Performing practical tests efficiently and quickly.
- Obtaining accurate results of laboratory tests.
- Collecting and interpreting laboratory samples.
- Timely reporting of laboratory information related to tests and diseases.
- Evaluate different laboratory testing methods for multiple variables and systems of care, among other tasks.
Administrative requirements for diverse laboratory practices (GCLP):
1. Establishing a quality assurance and control body for laboratory tests.
2. Evaluation of laboratory efficiency.
3. Enhancing the integration of healthcare systems to ensure cooperation between different laboratory teams.
4. Applying severe penalties for non-compliance with procedures.
5. Develop and implement training programs for workers in advanced laboratories.
6. Supporting the continuing professional development of laboratory workers.
7. Spreading awareness about the various applications of laboratories.
Benefits of good clinical laboratory practices:
- Strengthening laboratory standards.
- Enhancing confidence in the accuracy of testing, measurements and calibration results.
- Increasing patient and doctor confidence in laboratory services.
- Identify and correct non-compliant testing and calibration practices.
- Promoting a culture of continuous improvement.
The most important safety measures in laboratories that provide health care services are:
1. Wear a lab coat while in the laboratory with the buttons fastened tightly.
2. Wear a latex glove when handling samples.
3. Wear closed shoes.
4. Take off your gloves when using the phone or writing
5. If there are wounds, especially on the hands, they are covered with a waterproof bandage before work.
6. It is prohibited to bring private and personal supplies to the laboratory.
7. It is prohibited to consume food, drinks, or cigarettes in the laboratory.
8. Do not touch the face, eyes or mouth while working.
9. Work benches must be kept clean at all times.
10. Containers (safety box) must be provided to dispose of aspiration needles and glass slides, and they must be constantly changed.
11. Not writing and recording analyzes and results on the work bench and providing a safe environment for recording.
12. Substances and fluids from the human body are treated as infectious.
13. The materials or samples are rotated and separated in closed tubes while the device is closed.
14. The cultures, samples, and analyzed body parts are placed in a special container with a tightly sealed lid that prevents leakage during assembly, transportation, or storage.
15. Take off your coat and gloves and wash your hands before leaving the laboratory (routine washing).
16. Adherence to the hand washing policy.
17. Commitment to providing protective clothing and equipment (coats, gloves, eyeglasses, masks).
18. Commitment to wearing condoms while working.
19. Commitment to wearing a face protector when dealing with a substance that results in spraying.
20. Women should avoid using cosmetics.
21. Verify that your workplace is disinfected after finishing before leaving work.
22. Be careful not to scratch the skin with a syringe needle or glass letters. If this happens, wash the affected part under running water, then disinfected with 70% alcohol and covered with sterile adhesive tape.
Here are some links that provide more information on GCLP:
World Health Organization (WHO) GCLP guidelines: https://fctc.who.int
US Food and Drug Administration (FDA) guidance on GCLP: https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials
European Medicines Agency (EMA) GCLP guidelines: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-clinical-practice
These resources provide detailed information on the principles and implementation of GCLP in clinical laboratory settings.