Hospital licensing process_and streamlining_nbl_upcph_revised_21_may2012

• 1. Hospital Licensing ProcessRules and Requirements Explained DEPARTMENT OF HEALTHBUREAU OF HEALTH FACILITIES AND SERVICESAtty. Nicolas B. Lutero III, CESO IIIDirector IV

2. Objectives1. GeneralTo acquire a broad-based view of the hospitallicensing process.2. Specific To orient stakeholders on the rules andrequirements involved in hospital licensing; To clarifyissues andenlightenstakeholders on rules and requirements inhospital licensing. 3. Acronyms1. BHFS Bureau of Health Facilities and Services2. CHD Centerfor Health Development3. CON Certificate of Need4. PTC Permit to Construct5. OSS One-Stop Shop6. LTO License to Operate7. AO Administrative Order 4. DOH Websitewww.doh.gov.phDoing Business LicensingBHFS RequirementsHospitals and Other Health Facilities 5. The process has 3 phases:1. Pre-inspection Phase2. Inspection Phase3. Post-inspection Phase 6. 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. 7. Pre-inspection Phase2. Activities:a) Fill up application formb) Inspection activity agendac) Copy of Administrative Order and other related issuancesd) Checklist of documents to be available during inspection 8. Inspection PhaseGoal: To encourage interactive participation of the key staff in the inspection process. 9. Inspection PhaseActivities:b)Leadership interviewc)Document review sessiond)Tour of the health facilitye)Feedback session 10. Post-inspection PhaseGoal: To make a decision on the extent to which the health facility is able to meet the minimum licensing requirements. 11. 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. 12. Process Flow CHDSecretariatNOHealthDocuments facility complete owner YESCHD cashierPre-inspection Phase 13. Process Flow Head of the licensingteam at CHDAdditionalrequirementsInspectionMD, RN, RMT, FDRO, HEALTH Non-compliance proper plusPHYSICIST, ENGINEER feedback Compliance CHD director approves issuance of LTOInspection andPost-inspectionPhases 14. 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 15. CONCriteria for the establishment of a newgeneral hospital:2.Bed to population ratio shall not bemore than 1 bed per 1,000 population(1:1,000);3.Travel time proposed hospital shallbe at least 1 hour away from thenearest existing hospital;4.Accessibility strategically located; AO No. 2006 - 0004 16. CONCriteria for the establishment of a new general hospital:3.Integration withProvincial/CityStrategic Plan for the Rationalization ofthe Health Care Delivery System Basedon Health Needs;4.Track record. AO No. 2006 0004AO No. 2006 0004 AAO No. 2006 0004 BAO No. 2006 0029 17. CONRequirements for general hospitals: Application form for CON Certificationfrom the ProvincialPlanning and Development Office thatthe proposed hospital is part of theduly approved Provincial Hospital/Health Care Delivery Plan (if available)AO No. 2006 - 0004 18. Permit to Construct (PTC)A PTC is a pre-requisite for LTO.It is required for: Construction of a new hospital or otherhealth facility; Substantial alteration, expansion orrenovation of an existing hospital orother health facility; Change in classification Increase in bed capacityRepublic Act 4226 AO No. 147 s. 2004 19. 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) 20. One-Stop Shop (OSS)DOH strategy to harmonize licensure of hospitals, itsancillary 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 21. OSS ExclusionOSS excludes the following: Hospital-based medical facility foroverseas workers and seafarers; Hospital-based drug abuse treatmentand rehabilitation center; Facility using radioactive materialregulated by the PNRI; Performance of kidney transplantation. AO No. 2007 0021 22. Application for OSSRequired for all hospitals:2. Hospital documents3. Clinical Laboratory4. Pharmacy5. Radiology AO No. 2007 - 0021 23. 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 24. Classification of Hospitals A. By function1. General2. Special B. By service capability1. Level 12. Level 23. Level 34. Level 4AO No. 2005 - 0029 25. 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 LabAO No. 2007 - 0027DM No. 2009 - 0086 26. 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 27. Schedule of Feesa) The applicant, upon filing the application,shall pay at CHD or DOH cashier.b) Fees for the OSS licensure system shallbe regularly reviewed by BHFS and FDA inconsultation with CHDs and stakeholders.c) All fees, surcharges, and discounts shallfollow the current DOH prescribedschedule of fees. AO No. 2007 0023 28. Validity of LTOThe LTO shall be valid for one year from January 1 to December 31.AO No. 2007 0021Republic Act 4226 29. Sanctions 1st violation written warning Violations involving basic hospitallicensing requirements: 2nd violation Php 30,000.00 3rd violation Php 50,000.00AO No. 2007 - 0022 30. Sanctions1. Violations involving facilities/ servicesnot 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 31. SanctionsViolations involving basic hospitallicensing requirements: 4th violation suspension orrevocation of the LTOAO No. 2007 - 0022 32. Updates in Hospital LicensingStreamlining of Licensure and Accreditation of Hospitals(A.O. No. 2011 0020) DEPARTMENT OF HEALTHBUREAU OF HEALTH FACILITIES AND SERVICESAtty. Nicolas B. Lutero III, CESO IIIDirector IV 33. Rationale in the Streamlining of Licensure and Accreditation of Hospitals1. Simplification of processes2. Limited resources available3. To eliminate duplication in licensing and accreditation 34. Figure 1. Percent Distribution of DOH Licensed Hospitals as to Ownershipn = 1,8124% DOH-Retained36% Government60%PrivateSource: DOH BHFS 2010 35. Figure 2. Percentage of DOH LicensedHospitals with PhilHealth Accreditation n = 1,812 12% PhilHealth Accredited Non-PhilHealth Accredited88%Source: DOH BHFS andPHIC, 2010 36. OBJECTIVETo improve access to qualityhealth facilities with theefficient useof limitedgovernment resources andwithout compromising thequality of care 37. Scope and Coverage Regulatory offices BHFS,FDA, CHD, PhilHealth All government and privatehospitals 38. Acronyms1. BHFS Bureau of Health Facilities and Services3. CHD Center for Health Development4. FDA Food and Drug Administration 39. Strategies1. To harmonize DOH standards of safety and PhilHealth core indicators;3. Tostreamline regulatory processes by recognition of DOH licensed hospitals as Centers of Safety without the need for a separate survey by PhilHealth. 40. 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. 41. 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. 42. 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. 43. 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. 44. 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. 45. 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. 46. 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 47. 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. 48. Next StepsACTIVITYTIME 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 Hospitals1. Formulate and/or revise assessmentOngoing tool for licensure of hospitals1. Sharing of resources between DOH To be and PhilHealth (e.g. vehicle)discussed 49. Next Steps ACTIVITY TIME FRAME1. Implementation of RegulatoryOctober 2012 Scheme1. BHFS Information Management Unit Link with DOH-IMS and PhilHealth 50. BUREAU OF HEALTH FACILITIES AND SERVICESContact Number/ DivisionChief Email AddressStandards6517800 local 2525 Dr. Cynthia R. Development 7119572 (direct) Rosuman Division [email protected] and 6517800 local 2502-2504 Atty. Rodel C. Accreditation 7116982 (direct)Flores (OIC) Division [email protected] 6517800 local 2528Assurance and Dr. Beauty [email protected] Palongpalongcom DivisionAdministrative Ms. Teresa 6517800 local 2500UnitSalgado 51. Thank you.