REGULATION COMPLIANCE FOR CLINICAL LABORATORY

REGULATION COMPLIANCE

1. REGULATION COMPLIANCE

2. Laboratory compliance is the practice of following a set of standards created for the operation of a laboratory. These standards involve the handling of funds that support the laboratory as well as issues of fraud, waste, communication, training, lab maintenance, and record-keeping.

3. Republic Act No. 4688 s. 1966 An Act Regulating the Operation and Maintenance of Clinical Laboratories and Requiring the Registration of the Same with the Department of Health, Providing Penalty for the Violation Thereof, and for Other Purposes

4. Clinical laboratory services play an important role in the diagnosis, treatment, prevention and control of disease It is imperative that the laboratories generate accurate, precise and reliable laboratory test results in a timely manner

5. New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines

6. GENERAL GUIDELINES A. All CL shall secure DOH-LTO prior to its operation and must comply with the minimum regulatory standards and requirements at all times. B. The DOH-LTO shall be secured from the DOH regulatory office in accordance with DOH guidelines.

7. C. Only DOH-licensed institution-based CL may have a SCL which shall be located within the premises of the regulated health facility. D. A DOH-licensed CL may have MCL services as listed in Section IV of Annex A, provided, they adhere to the standard testing protocols.

8. E. The DOH-licensed CL shall not perform any examinations or testing beyond its authorized service capability.

9. CLASSIFICATION OF CLINICAL LABORATORIES 1. BY OWNERSHIP 2. BY INSTITUTIONAL CHARACTER 3. BY FUNCTION 4. BY SERVICE CAPABILITY

10. QUALITY IMPROVEMENT Every CL shall establish and maintain a system for continuous quality improvement activities. A. There shall be an Internal Quality Assurance Program which shall include: 1. An Internal Quality Control Program for technical procedures.

11. 2. An Internal Quality Assurance Program for inputs, processes and outputs. 3. A Continuous Quality Improvement Program covering all aspects of laboratory performance.

12. B. Shall participate in External Quality Assessment Program (EQAP) C. A periodic assessment shall be conducted by representatives from the top management

13. Assessment of Safety Requirements and Their Practices Among Teaching Laboratories of Health Institutes

14. BACKGROUND Laboratory work provides students with the ability to process skills, perform experiments and tests, and interpret experimental data. A lack of laboratory safety requirements and practice can affect the health of students, staff, and the environment.

15. School laboratory safety also includes established procedures and rules aimed at protecting laboratory personnel from injury preventing property damage and loss, and providing a safe working environment

16. Students of secondary school, high school, undergraduate, and graduate ages can be exposed to various hazards if they do not follow certain precautions when working in the laboratory Therefore, the current study provides updated safety requirements and practice information

17. METHODS An institutional-based descriptive study design was conducted among staff members of the Bule Hora University Institute of Health. 17 randomly selected academic staffs and laboratory assistants from 2 departments participated in the study. Data were collected through a: self-administered questionnaire and an observational checklist

18. SAMPLING DATA 10 (8 instructors, 2 laboratory assistants) were from the medical laboratory department, and 7 (6 instructors, 1 laboratory assistant) were from the environmental health department

19. DATA ANALYSIS

20. RESULTS

21. Among the assessed safety activities: 44.6% were always practiced 37.7% were sometimes practiced, and 17.6% were never practiced in 2 laboratories

22. 2. Based on shared knowledge of safety in the laboratories, 94.2% of the respondents used personal protective equipment while practicing/ teaching students, and 58.8% did not regularly inspect the safety of the laboratory rooms.

23. 3. Regarding the safety of the laboratory room for student practice or teaching. 53% agreed that the room was safe for student practice. On the other hand, 77% of respondents did not ever take training on laboratory safety

24. Based on the assessment, only 33.3% of safety requirements were fulfilled in the laboratories. There were expired laboratory reagents observed only in the medical laboratory room, while eyewash, emergency showers, fire blankets and fire extinguishers were absent in the environmental laboratory rooms.

25. Among the assessed laboratory safety requirements, first aid logbooks or guidelines, drainage systems in laboratory buildings, good ventilation, water flow and adequate laboratory size were absent

26. Observations show that teaching laboratories in health organizations lack safety manuals/first aid diaries or guidelines, laboratory building drainage systems, adequate ventilation, water flow, and appropriate laboratory sizes

27. Of the total respondents nearly half (47.1%) of them always shared their knowledge of laboratory safety with their students and colleagues, 82.4% of respondents always used personal protective equipment when practicing and teaching students, and 58.8% of participants did not use laboratory safety regularly in the room.

28. Additionally, issues were identified, such as uncleanliness of laboratory work rooms, improper labeling of laboratory chemicals/reagents, equipment and samples, and lack of inspection and quality control records around equipment.

29. The ultimate laboratory safety responsibility within an institution lies with its Superintendent, along with all urgent relations that should have an overt, continuing commitment to the safety program.

30. CONCLUSIONS This study revealed that laboratory safety practices and safety requirements in a teaching laboratory at a health research institute are poor. This is due to inadequate laboratory personnel practices, lack of training, and limited resources regarding laboratory equipment and materials required for safety. Additionally, poor ventilation, inadequate lab size, unseparated rooms, and practicing with unlabeled samples can contaminate student practice during practice.

31. CONCLUSIONS Instructors and laboratory assistants play and are responsible for the success of the program, among the fundamental roles played by the department heads. All levels of the organization should understand the importance of minimizing the risk of exposure to hazardous substances in the laboratory, and work together toward this goal is needed.