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Application for Renewal of License To Operate (LTO) of Non-hospital Based Clinical Laboratories in the Philippines

This is in accordance to 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” and DOH Administrative Order No. 2007-0027: Revised Rules and Regulations Governing the Licensure and Regulation Of Clinical Laboratories in the Philippines.

Every clinical laboratory shall be organized to provide quality, effective and efficient laboratory services.  A checklist for licensure of a general clinical laboratory is available which may serve as a guide for self-assessment of the facility.  To access the tool click the link here.

The LTO shall be issued only to clinical laboratories that comply with the standards and technical requirements formulated by the BHFS.

The procedural guideline is as follows:
  1.  Filing of application begins on the first day of October until the last day of November of the current year. A ten (10) percent discount on the renewal fee shall be granted if a complete application is filed during this period.
  2.  Applicants can acquire the prescribed application form for LTO from the BHFS, CHD that has jurisdiction over the existing clinical laboratory, or at the DOH website (www.doh.gov.ph)
  3.  The accomplished form together with the necessary attachments is to be submitted to the CHD that has jurisdiction over the existing clinical laboratory.  Incomplete attachments would not be accepted.  Trainings and seminars attended must be of the current year.
  4.  The applicant shall be required to pay a non-refundable application fee for LTO upon submission of the accomplished form.
  5.  Renewal of license for compliant clinical laboratories shall be processed not later than five (5) working days after the expiration date of its license.
  6.  The LTO of a clinical laboratory shall be automatically cancelled without notice when it fails to submit a duly accomplished application form and to pay the proper fee on or before the expiration date stated in its license.
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