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

Required Documents for Clinical Laboratory in the Renewal of License to Operate a Hospital (Updated on October 2012)

Applicant must first request relevant information and prescribed form from the Center for Health Development under whose jurisdiction the hospital is located.

All of the following documents for clinical laboratory section must be submitted before a license to operate can be renewed:

1. List of Personnel (use ANNEX A) 

2. Photocopies of the following:

Proof of qualification of pathologist and medical technologist
2.1 PRC ID
2.2 Board Certificate
2.3 Latest Certificate of Training/Seminar

3. List of Equipment, Reagent, Laboratory Ware and Materials for Specific Test (use ANNEX C) 

4. Quality Manual (changes only) 

5. 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)

5.1 Clinical Chemistry (LCP)
5.2 Hematology (NKTI)
5.3 Serology (SACCL)
5.4 Microbiology (RITM)

6. Notarized letter of intent to comply with the required blood service facility

7. Memorandum of Agreement, if not owned by the hospital

Upon filing of application, the applicant pays the corresponding fees for renewal of License to Operate to the Cashier of the Center for Health Development.