Mandate: Republic Act No. 4226, “Hospital Licensure Act” (1965)

The law requires that: (1) no hospital whether government or private shall be constructed or renovated unless plans have been approved and a construction permit has been issued by the Bureau of Medical Services (BMS); (2) any person, association, partnership, corporation or government entity desiring to construct, remodel, or repair a hospital building shall acquire the permit to construct; (3) no hospital whether public or private may operate without a license to operate (LTO); (4) all hospitals must meet certain prescribed technical standards in personnel, equipment, and physical facilities depending on the type of facility to assure patient safety.

With an Administrative Order issued by the Department of Health (DOH) in 1995, the One-Stop-Shop concept was introduced to the Bureau of Licensing and Regulation (BLR), formerly BMS, as the implementing office.

Pursuant to Executive Order No. 102s. 1998, “Redirecting the Functions and Operations of the Department of Health”, the DOH Central Office changed its organizational structure and the BLR has now become the Bureau of Health Facilities and Services. Under Administrative Order No. 2007-0021, “Harmonization and Streamlining of the Licensure System”, the licensing process of hospitals through the one-stop-shop licensure system was decentralized to DOH regional offices known as Centers for Health Development.

What is One-Stop-Shop Licensing System or the so-called OSS?

It is a strategy of the DOH to harmonize the licensure of hospitals, their ancillary and other facilities including, but not limited to the clinical laboratory, HIV testing, drinking water analysis and drug testing, blood banks, blood collection units and blood stations, dialysis clinics, ambulatory surgical clinics, pharmacies, and medical x-ray facilities, but excluding hospital-based medical facility for overseas workers and seafarers, hospital-based drug abuse treatment and rehabilitation center, facility using radioactive material that are currently regulated by PNRI and performance of kidney transplantation.

Features of OSS:

1. Only one (1) license to operate (LTO) is issued to a hospital inclusive of ancillary services like those of pharmacy, laboratory and x-ray.
2. Only one (1) office i.e. DOH Center for Health Development processes and issues the hospital’s license.
3. Only one (1) DOH licensing team inspects the hospital.

What are the steps in securing a license?

FOR INITIAL APPLICATIONS:

Step 1. Submit application for Certificate of Need (CON) to CHD (for new hospital and   reclassification of hospital from special to general)

Step 2. Secure CHD Approval

Step 3. Submit application for Permit to Construct (PTC) to CHD

Step 4. Secure approved PTC

Step 5. Submit application for LTO to CHD

Step 6. Inspection by the licensing team

Step 7. Issuance of LTO by the CHD

FOR RENEWAL APPLICATIONS:

Step 1. Submission of application for LTO to CHD

Step 2. Automatic renewal of LTO (Hospital should be continuously compliant with licensing standards and requirements, any deficiency shall be dealt accordingly.)

DISCOUNT OFFERED:

If renewal of LTO is filed on October 01 to November 30 of the current year, a ten percent (10%) discount on the renewal fee shall be granted.

REQUIREMENTS IN SECURING A LICENSE:

1. Notarized duly accomplished application form for license to operate a hospital
2. Approved DOH PTC
3. List of personnel including proof of qualifications
4. List of hospital equipment/instruments
5. List of health services including ancillary services offered
6. Location map for the hospital
7. Photographs of the exterior and interior of the hospital
8. Other required documents (SOPs, committees, plans and logbooks)
9. Annual Hospital Statistical Report

How long is the process?

1. The initial LTO is issued to the applicant within thirty (30) calendar days upon receipt of complete application requirements
2. Renewal LTO is issued immediately, usually not later than five (5) working days upon receipt of complete application requirements.

What is the validity period of the license?

The License to Operate (LTO) is valid for 365 days or a year.

What are the advantages and benefits of having a license?

• Patients feel safe and secure in your health facility

• Gains the trust and confidence of patients and their families

• Health facility and patients will be eligible for PHIC and/or other health insurance benefits

• Establishes a positive image to other health facilities

• Gains trust and confidence of stakeholders

• Boosts the morale and self-confidence of employees

• Prevents litigation against owners/personnel for illegal operation

Governing Laws:

Administrative Order No. 147 s. 2004: Amending Administrative Order No. 70-A, series 2002 re: Revised Rules and Regulations Governing the Registration, Licensure and Operation of Hospitals and Other Health Facilities in the Philippines

Administrative Order No. 2005-0029: Amendment to Administrative Order No. 147 s. 2004: Amending Administrative Order No. 70-A series 2002 re: Revised Rules and Regulations Governing the Registration, Licensure and Operation of Hospitals and Other Health Facilities in the Philippines

Administrative Order No. 2005-0029-A: Addendum to Administrative Order No. 2005-0029 entitled Amendment to Administrative Order No. 147 s. 2004: Amending Administrative Order No. 70-A s. 2002 re: Revised Rules and Regulations Governing the Registration and Operation of Hospitals and Other Health Facilities in the Philippines

Administrative Order No. 2006-0004: Guidelines for the Issuance of Certificate of Need to Establish a New Hospital

Administrative Order No. 2006-0004-A: Amendment to Administrative Order No. 2006-0004: Guidelines for the Issuance of Certificate of Need to Establish a New Hospital

Administrative Order No. 2007-0021: Harmonization and Streamlining of the Licensure System for Hospitals

Administrative Order No. 2007-0022: Violations under the One-Stop Shop Licensure System for Hospitals

Administrative Order No. 2007-0023: Schedule of Fees for the One-Stop Shop Licensure System for Hospitals

Administrative Order No. 2007-0024: Guidelines for the Licensure of Department of Health Hospitals

Administrative Order No. 2007-0041: Guidelines on the Mandatory Allocation of a Certain Percentage of the Authorized Bed Capacity as Charity Beds in Private Hospitals

Administrative Order No. 2008-0001: Implementing Rules and Regulations of Republic Act No. 9439, Otherwise Known as "An Act Prohibiting the Detention of Patients in Hospitals and Medical Clinics on Grounds of Non-Payment of Hospital Bills or Medical Expenses"

Department Memorandum No. 2008-0020: Reiterating the Provision of Newborn Screening Services as a Mandatory Licensing Requirement for All Hospitals

Administrative Order No. 2008-0026:  Addendum to the Rules and Regulations Implementing Republic Act No. 9288, Otherwise Known as the "Newborn Screening Act of 2004"

Department Memorandum No. 2008-0123: Newborn Screening Coverage

Department Memorandum No. 2008-0253:  Reiterating the Posting of Schedule of Fees for Laboratory and Other Diagnostic Services of Hospitals and Other Regulated Health Facilities as a Mandatory Requirement for Licensing or Accreditation

Administrative Order No. 2008-0002:  Posting of Schedule of Fees for Laboratory and Other Diagnostic Services of Hospitals and Other Health Facilities

Department Memorandum No. 2007-0099:  Permits Issued by Other National Government Agencies and by Local Government Units

Department Memorandum No. 2009-0042: Level 1 Hospitals and Other Health Facilities That Do Not Have a Pharmacy

1.    Application for Certificate of Need for General Hospitals

2.    Evaluation Tool - CON

3.    Evaluation Tool - CON for concurrent application

4.    Licensing Requirements

• Level 1

• Level 2

• Level 3

• Level 4

5.    Guidelines in the Planning and Design of a Hospital and other Health Facilities

6.    Application for Permit to Construct

7.    Checklist for Review of Floor Plans

• Level 1

• Level 2

• Level 3

• Level 4

• Comments

8.    Application for License to Operate a Hospital (Initial and Renewal)

• Annex A - List of Personnel

• Annex B - List of Equipment

• Annex C - List of Equipment, Reagent, Laboratory Ware and Materials for Specific Test

• Annex D - List of Products

• Annex E - List of Diagnostic Radiology and Radiation Oncology Services by Category

• Annex F - List of Personnel for Diagnostic Radiology and Radiation Oncology Services

• Annex G - List of X-ray Machines

• Annex H - List of Equipment, Laboratory Ware and Materials

• Annex I - List of Testing Materials

• Annex J - List of Parameters for Each Service Capability

• Annex K - List of Equipment, Reagent, Laboratory Ware and Materials for Specific Test

9.    Affidavit of Undertaking for Renewal of License to Operate a DOH Hospital

10.    Format of License to Operate a Hospital

11.    Asessment Tool (for Facility Owners)

• Level 1

• Level 2

• Level 3

• Level 4

12.    Inspection Tool (for Regulatory Officers)

• Level 1

• Level 2

• Level 3

• Level 4

13.    Summary of Evaluation

14.    Report

• Annual Hospital Statistical Report Form (for Hospital)

• Annual Summary of Hospital Performance (for CHD)

• Annual / Quarterly Status Report of Hospitals (for CHD)(Updated Y2009)

15.    Implementing Guidelines on the Licensure Standards for Hospitals for Regulatory Officers