DEPARTMENT OF HEALTH BUREAU OF HEALTH FACILITIES AND SERVICES

Atty. Nicolas B. Lutero III, CESO III

Director IV

Hospital Licensing Process

“Rules and Requirements Explained”

Objectives

1. General

To acquire a broad-based view of the hospital licensing process.

2. Specific To orient stakeholders on the rules and

requirements involved in hospital licensing; To clarify issues and enlighten

stakeholders on rules and requirements in hospital licensing.

Acronyms

1. BHFS – Bureau of Health Facilitiesand Services

2. CHD – Center for Health Development 3. CON – Certificate of Need 4. PTC – Permit to Construct5. OSS – One-Stop Shop6. LTO – License to Operate7. AO – Administrative Order

DOH Website

www.doh.gov.ph

Doing Business

Licensing

BHFS Requirements

Hospitals and Other Health Facilities

The process has 3 phases:

1. Pre-inspection Phase

2. Inspection Phase

3. Post-inspection Phase

Pre-inspection Phase

1. Goal:

a) To coordinate with the health facility to be visited;

b) To inform the management of the purpose of the inspection and their participation in the activity.

Pre-inspection Phase

2. Activities:

a) Fill up application form

b) Inspection activity agenda

c) Copy of Administrative Order and other related issuances

d) Checklist of documents to be available during inspection

Inspection Phase

Goal:

To encourage interactive participation of the key staff in the inspection process.

Inspection Phase

Activities:

a)Leadership interview

b)Document review session

c)Tour of the health facility

d)Feedback session

Post-inspection Phase

Goal:

To make a decision on the extent to which the health facility is able to meet the minimum licensing requirements.

Post-inspection Phase

Activities:

a)Regulatory officers collate findings.

b)The team prepares the report.

c)The team submits the report together with its recommendations to the director of the CHD.

d)The CHD director approves or disapproves the issuance of the LTO.

Process Flow

CHD Secretariat

Documents complete

Health facility owner

NO

CHD cashier

YES

Pre-inspection Phase

Process FlowHead of the licensing

team at CHD

Inspection proper plus

feedback

MD, RN, RMT, FDRO, HEALTH

PHYSICIST,ENGINEER

CHD director approves issuance of LTO

Additional requirements

Compliance

Non-compliance

Inspection and Post-inspection

Phases

Hospital Licensing Process

PROCESS

STANDARDS

Legislative Acts Rules & Regulations Technical Requirements Administrative SOPs Manuals

INPUT

Manpower Forms Office/ furniture Clerical support Travel fund

Application Payment of fees Processing Inspection Evaluation Action Education

OUTPUT

Accomplished forms(application, inspection, evaluation forms) Certificate of Need Permit to Construct Hospital license Reports Enlightened hospital staff

Review of accomplished forms (application, inspection, evaluation) Monitoring reports Oral reports Written reports Complaints Consultation meetings Hospital performance

FEEDBACKBHFS/ CHD DOH

Certificate of Need (CON)

A legal document issued by the CHD regulatory agency with authority over an area which affirms that a proposed acquisition, expansion or creation of a medical facility falling under that authority is required to fulfill the needs of a community.

This certificate is necessary for the construction of a medical facility to be issued by the responsible CHD.

www.wikipedia

CON

Criteria for the establishment of a new general hospital:

1.Bed to population ratio shall not be more than 1 bed per 1,000 population (1:1,000);

2.Travel time – proposed hospital shall be at least 1 hour away from the nearest existing hospital;

3.Accessibility – strategically located; AO No. 2006 - 0004

CON

Criteria for the establishment of a new general hospital:

4.Integration with Provincial/ City Strategic Plan for the Rationalization of the Health Care Delivery System Based on Health Needs;

5.Track record.

AO No. 2006 – 0004 B

AO No. 2006 – 0004 A

AO No. 2006 – 0004

AO No. 2006 – 0029

CON

Requirements for general hospitals: Application form for CON Certification from the Provincial

Planning and Development Office that the proposed hospital is part of the duly approved Provincial Hospital/ Health Care Delivery Plan (if available)

AO No. 2006 - 0004

Permit to Construct (PTC)

A PTC is a pre-requisite for LTO.It is required for:

Construction of a new hospital or other health facility;

Substantial alteration, expansion or renovation of an existing hospital or other health facility;

Change in classification Increase in bed capacity

AO No. 147 s. 2004

Republic Act 4226

Application for PTC

1. Three sets of site development & architectural floor plans:

a) Signed and sealed by an architect

b) Showing all areas with appropriate scale, dimensions, and labels

2. For new hospitals:

a) CON from the CHD

b) Zoning certificate/ location clearance from the City/ Municipal Planning and Development Office

c) DTI/ SEC Registration (for private hospital)

d) Board Resolution (for government hospital)

One-Stop Shop (OSS)DOH strategy to harmonize licensure of hospitals, its

ancillary and other facilities, such as but not limited to, the following: Clinical laboratory; HIV testing; Drinking water analysis; Drug testing; Blood bank, blood collection unit, and blood station; Dialysis clinic; Ambulatory surgical clinic; Pharmacy; Medical x-ray facility.

AO No. 2007 – 0021

OSS Exclusion

OSS excludes the following: Hospital-based medical facility for

overseas workers and seafarers; Hospital-based drug abuse treatment

and rehabilitation center; Facility using radioactive material

regulated by the PNRI; Performance of kidney transplantation.

AO No. 2007 – 0021

Application for OSS

Required for all hospitals:

1. Hospital documents

2. Clinical Laboratory

3. Pharmacy

4. Radiology

AO No. 2007 - 0021

OSS

When provided by the hospital :

1. Dialysis Clinic

2. Blood Station/ Blood Collection Unit

3. Blood Bank

4. HIV Testing Laboratory

5. Laboratory for Drinking Water Analysis

6. Drug Testing Laboratory

7. Ambulatory Surgical Clinic

8. Birthing home or CEmOC AO No. 2007 - 0021

Classification of Hospitals

A. By function

1. General

2. Special

B. By service capability

1. Level 1

2. Level 2

3. Level 3

4. Level 4AO No. 2005 - 0029

Classification of Clinical Labs

By service capability

1. General Clinical Lab

a. Primary Category

b. Secondary Category

c. Tertiary Category

d. Limited Service

2. Special Clinical Lab

DM No. 2009 - 0086

AO No. 2007 - 0027

Classification of X-ray Facilities

By service capability:

1. Level 1 – < 100 ma

2. Level 2 – > 100 ma

special procedures with contrast

3. Level 3 – > 300 ma with image intensifier system

(e.g. interventional radiology)

AO No. 35 s. 1994

Schedule of Fees

a) The applicant, upon filing the application, shall pay at the CHD or DOH cashier.

b) Fees for the OSS licensure system shall be regularly reviewed by the BHFS, BHDT, and BFAD in consultation with the CHDs and stakeholders.

c) All fees, surcharges, and discounts shall follow the current DOH prescribed schedule of fees.

AO No. 2007 – 0023

Validity of LTO

The LTO shall be valid for one year from January 1 to December 31.

AO No. 2007 – 0021

Republic Act 4226

Sanctions

1. 1st violation – written warning

2. Violations involving basic hospital licensing requirements:

2nd violation – Php 30,000.00

3rd violation – Php 50,000.00

AO No. 2007 - 0022

Sanctions

3. Violations involving facilities/ services not

required for hospital licensure:

2nd violation – Php 20,000.00

Every subsequent violation – additional 20% of the previous fine

4. Fine imposition procedures:

Fines should be paid within 10 working days after receipt of the official notice.

A surcharge of 3% shall be imposed for each month of delay in payment. AO No. 2007 - 0022

Sanctions

Violations involving basic hospital

licensing requirements:

4th violation – suspension or revocation of the LTO

AO No. 2007 - 0022

ISSUES/ CONCERNS

cyros_2005@yahoo.com.ph

711-95-72, 743-83-01 loc 2525

Standards Development Division

Bureau of Health Facilities and Services

Department of Health

BHFS

Division Contact

person Landline

Licensing and Accreditation

Division

Monitoring & Surveillance

Division

Standards Development

Division

Dr. Cynthia Rosuman

743-8301 loc 2525;

711-9572

Dr. Mercedes Palma

Dr. Beauty Palongpalong

743-8301 loc 2502 – 2504; 711-6982

743-8301 loc 2528

Related Issuances

Health Facility AO

AO No. 163 s. 2004

IRR revised July 11, 2003

Dialysis Clinic

Blood Station/ Blood Collection Unit

Blood Bank

AO No. 2008 – 0008

AO No. 2005 – 0027

AO NO. 2006 – 0024

AO No. 183 s. 2004

AO No. 2008 – 0008

HIV Testing Laboratory

Laboratory for Drinking Water Analysis

Drug Testing Laboratory

Ambulatory Surgical Clinic

Birthing Home or CEmOC AO No. 2007 – 0039