hospital licensing process_up_cph[1]
TRANSCRIPT
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
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