Streamlining would benefit patients, DOH and PHIC Limited resources available in the implementation of licensing and accreditation requires collaboration between DOH and PHIC to pool resources together to achieve efficiency To address the clamor from the hospital sector for DOH and PHIC to synchronized efforts to eliminate duplication in licensing and accreditation without compromising the quality of care.
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
Certificate of Need (CON)A Certificate, issued by CHD for the proposed construction of a new general hospital, which ensures that the facility will be needed at the time of its completion. The Certificate is issued to an individual or group intending to build a hospital in order to meet the needs of a community.A CON is a required document prior to the issuance of a DOH-PTC for construction of a new general hospital . 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. Ambulatory Surgical Clinic AO No. 2007 - 0021 AO No. 2010 - 0035
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 CHD or DOH cashier.b) Fees for the OSS licensure system shall be regularly reviewed by BHFS and FDA in consultation with 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
Updates in Hospital Licensing “Streamlining of Licensure and Accreditation of Hospitals” (A.O. No. 2011 – 0020) DEPARTMENT OF HEALTHBUREAU OF HEALTH FACILITIES AND SERVICES Atty. Nicolas B. Lutero III, CESO III Director IV
Rationale in the Streamlining of Licensure and Accreditation of Hospitals1. Simplification of processes2. Limited resources available3. To eliminate duplication in licensing and accreditation
Figure 1. Percent Distribution of DOH Licensed Hospitals as to Ownership n = 1,812 4% DOH-Retained 36% Government60% Private Source: DOH – BHFS 2010
Figure 2. Percentage of DOH LicensedHospitals with PhilHealth Accreditation n = 1,812 12% PhilHealth Accredited Non-PhilHealth Accredited 88% Source: DOH – BHFS and PHIC, 2010
OBJECTIVETo improve access to qualityhealth facilities with theefficient use of limitedgovernment resources andwithout compromising thequality of care
Scope and Coverage Regulatory offices – BHFS, FDA, CHD, PhilHealth All government and private hospitals
Acronyms1. BHFS – Bureau of Health Facilities and Services3. CHD – Center for Health Development4. FDA – Food and Drug Administration
Strategies1. To harmonize DOH standards of safety and PhilHealth core indicators;3. To streamline regulatory processes by recognition of DOH licensed hospitals as Centers of Safety without the need for a separate survey by PhilHealth.
Definition of Terms1. LTO – refers to License to Operate. It is the formal authorization issued by DOH through BHFS/CHD to an individual, partnership, corporation or association to operate a hospital and/or other health facility upon compliance with the minimum standards of safety. It is a pre-requisite for accreditation of a hospital and/or other health facility by any accrediting body recognized by DOH.
Definition of Terms1. Accreditation – a process whereby the qualifications and capabilities of health care providers are verified in accordance with the guidelines, standards and procedures set by the accrediting body for the purpose of conferring upon them certain privileges and assuring that health care services rendered by these providers are of the desired and expected quality.
Definition of Terms1. Assessment Tool – the checklist which prescribes the minimum standards and requirements for hospital licensure. It is the tool used by the regulatory officers to evaluate compliance of a hospital to DOH requirements. This tool shall also serve as the Self-Assessment Tool to be used by hospitals prior to inspection/ monitoring visits by DOH.
DOH LICENSE1. All DOH licensed hospitals shall be deemed automatically accredited by PhilHealth as Centers of Safety.3. Stakeholders shall follow the standards and requirements prescribed in the enhanced assessment tool for licensure of hospitals posted at DOH website.
Philhealth AccreditationAll DOH licensed hospitals shall bedeemed automatically accredited byPhilHealth as Centers of Safety.Such hospital shall no longer besurveyed by PhilHealth as a pre-requisite for accreditation.
PhilHealth AccreditationHospitals applying for Center of Qualityand Center of Excellence shall undergoa separate survey by PhilHealth prior togranting of the award.Should they fail to meet the requiredscores for the award they applied for, theyshall be downgraded to the appropriateaward or at least as a Center of Safety.
Reports to be submitted by BHFS/CHD1. Listing of hospitals Status of LTO of hospitals and hospital based facilities Consolidated hospital statistical report Consolidated report on deficiencies and violations in licensing requirements of government and private hospitals Consolidated report on sanctions, penalties and complaints against hospitals
Information Dissemination1. Publication of DOH licensed hospitals annually to provide the public with a selection of hospital facilities to choose from.3. Posting of licensed hospitals at DOH website upon issuance of LTO.
Next Steps ACTIVITY TIME FRAME• Conduct training of Regulatory Officers pursuant to A.O. No. Ongoing up to 2011-0020 re: “Streamlining of October 1, Licensure and Accreditation of 2012 Hospitals”1. Formulate and/or revise assessment Ongoing tool for licensure of hospitals1. Sharing of resources between DOH To be and PhilHealth (e.g. vehicle) discussed
Next Steps ACTIVITY TIME FRAME1. Implementation of Regulatory October 2012 Scheme1. BHFS Information Management Unit Link with DOH-IMS and PhilHealth
BUREAU OF HEALTH FACILITIES AND SERVICES Contact Number/ Division Chief Email Address Standards 6517800 local 2525 Dr. Cynthia R. Development 7119572 (direct) Rosuman Division firstname.lastname@example.orgLicensing and 6517800 local 2502-2504 Atty. Rodel C. Accreditation 7116982 (direct) Flores (OIC) Division email@example.com Quality 6517800 local 2528Assurance and Dr. Beauty A. bapalongpalong@yahoo. Monitoring Palongpalong com DivisionAdministrative Ms. Teresa 6517800 local 2500 Unit Salgado