| # |
PHL-SCDC REQUIERMENT |
AGREEMENT |
| Yes |
No |
| SPECIMEN ANALYSIS |
| 1 |
Negative pressure room with Adequate ventilation for sample processing (-12) with monitor |
|
|
| 2 |
Certified Biological Safety Cabinet (BSC) Class II –B2 Ducted |
|
|
| 3 |
Clean Room with PCR workstation for reagent prepration |
|
|
| 4 |
Availability of PPE including respirators (NIOSH certified N95) |
|
|
| 5 |
The seal/fitness test of disposable particulate respirator for Staff |
|
|
| 6 |
Training of staff for Infection Control with certificates. |
|
|
| 7 |
Physical security available 24/7 to cover all shifts |
|
|
| 8 |
All analyzers are maintained as per manufacturer instructions |
|
|
| 9 |
All lab General equipment are calibrated |
|
|
| 10 |
All required documentation:
- Written specimen handling and receiving SOP
- Written method validation SOP
- Written test Analysis SOP including calibration and QC procedure
- Written Lab Analyzer SOP
- Written rejection criteria guidelines or SOP and rejection log sheet
|
|
|
| REPORTING OF RESULTS |
| 1 |
Use MOH HESN program for result reporting |
|
|
| SPECIMEN STORAGE AND WASTE MANAGEMENT
|
| 1 |
Specimen must be stored in an appropriate condition before and after testing in secured area
|
|
|
| 2 |
Autoclave must be available and maintained |
|
|
| 3 |
Disinfectants solutions and biological spill kit must be available and efficient |
|
|
| LABORATORY CAPACITY |
| 1 |
The laboratory has Nucleic Acid extraction Systems |
|
|
|
|
| 2 |
The laboratory has Real-Time PCR Systems |
|
|
|
|
| 3 |
The laboratory has adequate number of licensed Clinical Laboratory Technologists with experience in Molecular Biology. |
|
|
| 4 |
The laboratory has at least one consultant Microbiologist with experience in Molecular Microbiology |
|
|
| Attachments |
| BSC Calibration Certificate |
| SCFHS for Consultant Microbiologist please scan all the 5 licenses in 1 PDF |
