Hospital Licensing Process“Rules and Requirements Explained” DEPARTMENT OF HEALTHBUREAU OF HEALTH FACILITIES AND SERVICES Atty. Nicolas B. Lutero III, CESO III Director IV
Objectives1. 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.
Acronyms1. BHFS – Bureau of Health Facilities and Services2. CHD – Center for Health Development3. CON – Certificate of Need4. 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 RequirementsHospitals and Other Health Facilities
The process has 3 phases:1. Pre-inspection Phase2. Inspection Phase3. Post-inspection Phase
Pre-inspection Phase1. 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 Phase2. 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 PhaseGoal: To encourage interactive participation of the key staff in the inspection process.
Inspection PhaseActivities:b)Leadership interviewc)Document review sessiond)Tour of the health facilitye)Feedback session
Post-inspection PhaseGoal: To make a decision on the extent to which the health facility is able to meet the minimum licensing requirements.
Post-inspection PhaseActivities:b)Regulatory officers collate findings.c) The team prepares the report.d)The team submits the report together with its recommendations to the director of the CHD.e)The CHD director approves or disapproves the issuance of the LTO.
Process Flow CHDSecretariat NO HealthDocuments facility complete owner YESCHD cashier Pre-inspection Phase
Process Flow Head of the licensing team at CHD Additionalrequirements Inspection MD, RN, RMT, FDRO, HEALTH Non-compliance proper plus PHYSICIST, ENGINEER feedback Compliance CHD director approves issuance of LTO Inspection and Post-inspection Phases
Hospital Licensing Process STANDARDS BHFS/ FEEDBACK CHD Review of accomplished Legislative Acts Rules & Regulations DOH forms (application, inspection, evaluation) Technical Requirements Monitoring reports Administrative SOPs Oral reports Manuals Written reports Complaints Consultation meetings Hospital performance INPUT PROCESS OUTPUT Manpower Application Accomplished forms(application, Forms Payment of fees inspection, evaluation forms) Office/ furniture Processing Certificate of Need Clerical support Inspection Permit to Construct Travel fund Evaluation Hospital license Action Reports Education Enlightened hospital staff
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
CONCriteria for the establishment of a new general hospital:2.Bed to population ratio shall not be more than 1 bed per 1,000 population (1:1,000);3.Travel time – proposed hospital shall be at least 1 hour away from the nearest existing hospital;4.Accessibility – strategically located; AO No. 2006 - 0004
CONCriteria for the establishment of a new general hospital:3.Integration with Provincial/ City Strategic Plan for the Rationalization of the Health Care Delivery System Based on Health Needs;4.Track record. AO No. 2006 – 0004 AO No. 2006 – 0004 A AO No. 2006 – 0004 B AO No. 2006 – 0029
CONRequirements 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 Republic Act 4226 AO No. 147 s. 2004
Application for PTC1. Three sets of site development & architectural floor plans: a) Signed and sealed by an architect b) Showing all areas with appropriate scale, dimensions, and labels2. 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 ExclusionOSS 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 OSSRequired for all hospitals:2. Hospital documents3. Clinical Laboratory4. Pharmacy5. Radiology AO No. 2007 - 0021
OSSWhen provided by the hospital :2. Dialysis Clinic3. Blood Station/ Blood Collection Unit4. Blood Bank5. HIV Testing Laboratory6. Laboratory for Drinking Water Analysis7. Drug Testing Laboratory8. Ambulatory Surgical Clinic9. 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 4 AO No. 2005 - 0029
Classification of Clinical LabsBy service capability 1. General Clinical Lab a. Primary Category b. Secondary Category c. Tertiary Category d. Limited Service 2. Special Clinical Lab AO No. 2007 - 0027 DM No. 2009 - 0086
Classification of X-ray FacilitiesBy 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 Feesa) 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 LTOThe LTO shall be valid for one year from January 1 to December 31. AO No. 2007 – 0021 Republic Act 4226
Sanctions1. Violations involving facilities/ services not required for hospital licensure: 2nd violation – Php 20,000.00 Every subsequent violation – additional 20% of the previous fine4. 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
SanctionsViolations involving basic hospital licensing requirements: 4th violation – suspension or revocation of the LTO AO No. 2007 - 0022
ISSUES/ CONCERNS firstname.lastname@example.org 711-95-72, 743-83-01 loc 2525 Standards Development DivisionBureau of Health Facilities and Services Department of Health
BHFS Division Contact Landline person StandardsDevelopment Dr. Cynthia 743-8301 loc 2525; Division Rosuman 711-9572Licensing andAccreditation Dr. Mercedes 743-8301 loc 2502 – Division Palma 2504; 711-6982Monitoring &Surveillance Dr. Beauty 743-8301 loc 2528 Division Palongpalong
Related Issuances Health Facility AO Dialysis Clinic AO No. 163 s. 2004 Blood Station/ Blood AO No. 2008 – 0008 Collection Unit Blood Bank AO No. 2008 – 0008 HIV Testing Laboratory AO No. 2005 – 0027 Laboratory for Drinking AO NO. 2006 – 0024 Water AnalysisDrug Testing Laboratory IRR revised July 11, 2003Ambulatory Surgical Clinic AO No. 183 s. 2004Birthing Home or CEmOC AO No. 2007 – 0039