ACCOMMODATION AND ENVIRONMENTAL CONDITIONS

KAN-TN-LP 02 Issue Number : 3 April 2016 Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded 2 d. Laboratory management shall ensure that : i. Appropriate numbers of laboratory personnel, with the required education training, to meet the demands of the service to customers. ii. Laboratory personnel have the knowledge, skills, and abilities based on education, experience, demonstrated skills, and training. To perform their duties. iii. Laboratory personnel had trained in handling pathogenic agents. iv. Full educational and professional records of all technical staffs available to confirm their competence in microbiology testing. e. Laboratory shall establish and define an internal training program and ensure the competency of laboratory personnel. f. Laboratory shall have training procedure that used to ensure that training has taken place with each employee for procedures and methods that the employee performs. The procedure applies to on-the-job training, in-house training and new- hire training. g. The training procedure is applicable to new employees, for the introduction of new procedures and methods, for retraining of employees, and for re-verification of employee performance. h. The laboratory shall maintain an up-to-date record of the training that each member of staff has received.

3. ACCOMMODATION AND ENVIRONMENTAL CONDITIONS

a. The laboratories are designed to : i. Provide space, engineering controls, and proper environmental conditions for optimal sample storage, sample handling, and analysis, in accordance with general laboratory practices. ii. Minimize areas with cracks or fibers that could serve to accumulate debris and serve as an area for growth of microorganisms. KAN-TN-LP 02 Issue Number : 3 April 2016 Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded 3 iii. Floors in the laboratories are constructed from a material that is resistant to easily disinfected. iv. Floors in the laboratories are clean, dry, and in sound condition so there are no tripping hazards. v. Environment suitable for the tasks carried out microbiology testing. b. Laboratory shall have : i. Distinct space, in line with the biosafety requirements, for performing microbiology testing. ii. Facilities that meet the required environmental conditions, including any needed separation of work areas to ensure that analyses will not be adversely affected within resources provided. iii. Written policies for handling spills of contaminated materials. iv. Laboratory storage areas provide proper storage of samples, reagents, microbiological media, select agents, standards and reference materials, and hazardous waste. Procedures and facilities in place for collection, storage and disposal of biohazard waste. v. Laboratory monitored and documented the air quality of work places where clean operation is expected. c. Laboratory shall have separate location provided for : i. Sample reception and preparation ii. Manipulation of pathogens relevant to their hazard level iii. Cleaning of lab-wares, decontamination and sterilization Appropriate biological safety cabinet for handling bacteria that highly contagious by air-borne routes d. Laboratory shall have separate chambers or enclosures provided for i. Storing of reference cultures, ii. Storing of samples, iii. Storing of reagents and media. KAN-TN-LP 02 Issue Number : 3 April 2016 Dokumen ini tidak dikendalikan jika diunduh Uncontrolled when downloaded 4

4. TEST METHOD AND METHOD VALIDATION