Checklist of Application Documents For A General Clinical Laboratory

This is intended for clinical laboratories under the jurisdiction of Center for Health Development 3. Always prepare a duplicate copy of all the documents submitted.

1. Notarized Application for License to Operate a Clinical Laboratory (this form)

2. List of Personnel

3. Photocopies of the following:

3.1. Proof of qualification of the medical and paramedical staff

• Valid PRC ID
•  Specialty Board Certificate of the medical staff
•  Certificate of Training/ Record of Work Experience

3.2. Proof of employment of the medical, paramedical and administrative staff (Contract of Employment must be provided) 

3.3. Current Authority to Practice for government pathologists (AO No. 161 s. 2000)

4. List of Equipment/ Instrument

5. Location Map for the clinical laboratory building

6. SEC/ DTI Registration (for private clinical laboratories) OR Issuance of Board Resolution (for government clinical laboratories)

7. Quality Manual of Clinical Laboratory (to be fully implemented by January 2009)

8. Certificate of Participation in External Quality Assessment Program for the current year and EQAP results of the previous year's participation. (If the certificate is not yet available, please present a copy of the received application form together with the proof of payment)

• Clinical Chemistry (LCP)
• Hematology (NKTI)
• Serology (SACCL)
• Microbiology (RITM)Certificate of Participation in External Quality Assurance Program

 Please check also the following links:

• Procedural Guideline
• Application Form