Example: marketing

DOH Scanned Document

RepublicofthePhilippinesDepartmentofHeal thOFFICEOF (014 SUBJECT:GuidelinesinSecuringaLicensetoOp erateaCOVID-19 TestingLaboratoryin thePhilippinesRATIONALE/BACKGROUNDT hecurrentpandemic,CoronavirusDisease2019 (COVID-19), ,asofApril1,2020,showedthat thereare227 additionalnewconfirmedcaseswithpositivet estresults,bringingthenumberto2,311infec tedcasesin thecountry, standardtestingprocedurefordetectingSeve reAcuteRespiratorySyndromeCoronavirus2(S ARS-CoV-2),thecausativeagentofCOVID-19,i stheRealTimeReverseTranscriptase PolymeraseChainReaction(rRT-PCR)asrecomm endedbytheWorldHealthOrganization(WHO).I tssensitivitytodetectthepresenceofthevir usearlyonwill resultin the immediateenforcementofprecautionarymeasu res, , ,and theirservicesincludegenotyping,identifyi ngmutationdefects,deoxyribonucleicacid(D NA) ,onlythe ResearchInstituteforTropicalMedicine(RIT M) beingissuedto setthestandardsinlicensingCOVID-19testin glaboratoriesasastrategytoexpandtestingc apacity,tohavemorecapablelaboratories, , , ,SanLazaroCompound,RizalAvenue, ,1003 Manila@ anindividual,partnership, ahealthfacilitywhereCOVID-19testing(SARS -CoV-2detection)isdoneonspecimensfromthe humanbodytoobtaininformationaboutthe healthstatusofapatientfortheprevention, (DOH-LTO))

b) Molecular Diagnostics. 3. Thestaffshallbeproficienton Molecular Diagnostic Techniques. 4. The staff shall undergo fit testing for respirator with at least 95% efficiency e.g.N95 mask. 5. Thestaffshallhaveanannual medical examination including influenza vaccination. 6. The staff shall have continuing updated trainings on biosafety and

Tags:

  Biosafety, Molecular

Information

Domain:

Source:

Link to this page:

Please notify us if you found a problem with this document:

Other abuse

Transcription of DOH Scanned Document

1 RepublicofthePhilippinesDepartmentofHeal thOFFICEOF (014 SUBJECT:GuidelinesinSecuringaLicensetoOp erateaCOVID-19 TestingLaboratoryin thePhilippinesRATIONALE/BACKGROUNDT hecurrentpandemic,CoronavirusDisease2019 (COVID-19), ,asofApril1,2020,showedthat thereare227 additionalnewconfirmedcaseswithpositivet estresults,bringingthenumberto2,311infec tedcasesin thecountry, standardtestingprocedurefordetectingSeve reAcuteRespiratorySyndromeCoronavirus2(S ARS-CoV-2),thecausativeagentofCOVID-19,i stheRealTimeReverseTranscriptase PolymeraseChainReaction(rRT-PCR)asrecomm endedbytheWorldHealthOrganization(WHO).I tssensitivitytodetectthepresenceofthevir usearlyonwill resultin the immediateenforcementofprecautionarymeasu res, , ,and theirservicesincludegenotyping,identifyi ngmutationdefects,deoxyribonucleicacid(D NA) ,onlythe ResearchInstituteforTropicalMedicine(RIT M) beingissuedto setthestandardsinlicensingCOVID-19testin glaboratoriesasastrategytoexpandtestingc apacity,tohavemorecapablelaboratories, , , ,SanLazaroCompound,RizalAvenue, ,1003 Manila@ anindividual,partnership, ahealthfacilitywhereCOVID-19testing(SARS -CoV-2detection)isdoneonspecimensfromthe humanbodytoobtaininformationaboutthe healthstatusofapatientfortheprevention, (DOH-LTO) aformalauthorizationissuedbytheDOHthroug htheHealthFacilitiesandServicesRegulator yBureau(HFSRB))

2 Toanindividual,partnership,corporationor associationseekingtoperformSARS-CoV-2det ectioninaCOVID-19testinglaboratoryincomp liancewiththerequirementsprescribedin apermitissuedbyDOHthroughHFSRB toanapplicantwhowillestablishandoperatea COVID-19testinglaboratory,uponcompliance withrequireddocumentssetforthinthisOrder priortoactualconstructionofthe ,expansion,renovation, aformalendorsementissuedbyRITM oritsdulyrecognized/authorizedassessorsu ponfullcomplianceoftheapplicantwiththeir requirements, TimeReverseTrans iptase PolymeraseChainReaction(rRT-PCR)-aPCRtes tdesignedtodetect, translatedintoacomplementaryDNAwhichwill then Fornon-hospital-basedCOVID-19 theDOH-LTOofCOVID-19testinglaboratorysha llbe theDOH-LTOofCOVID-19testinglaboratorysha llbe ,with ,as prescribedbytheRITM basedonWHOrecommendations, , ,whichshallinclude,butnotlimitedto,thest andardoperatingproceduresbeingimplemente dinthefacility;policiesandproceduresonbi osafetyandbiosecurity,handlingandtranspo rtingofspecimens;disposalofinfectiouswas tes;InfectionPreventionandControl;record smanagement;preventivemaintenanceofthefa cilityand theequipment.

3 ,reagentsand , ,2020,titled DirectivetoAll Publicand PrivatehospitalsandHealthcareFacilitieso nReportingCoronavirusDisease(COVID-2019) ,criteriaandrequirementsprescribedin theDOHA ssessmentToolforLicensingaCOVID-19testin glaboratory(ANNEXA),RITM sBiosafetyandLaboratoryAssessmentTool(AN NEXB1andANNEXB2),andaccomplishtheWHOrisk assessmentform(ANNEXC). )Government- createdbylaw. Agovernmentfacilitymaybeunderthenational government,DOH,localgovernmentunit(LGU), DepartmentofNationalDefense(DND),Philipp ineNationalPolice(PNP),DepartmentofJusti ce(DOJ),StateUniversitiesandColleges(SUC s),GovernmentOwnedand ControlledCorporations(GOCCs)and )Private owned,establishedandoperatedwithfundsthr oughdonation,principal,investmentorother meansbyanyindividualcorporation, ,partnership,corporation,cooperative,fou ndation,religious,non-governmentorganiza tionand )HospitalBased ,butwithaspecificdesignatedroomdistinctf romthe ) Non-hospital-based , adequatenumberofpersonnel, (7),butmaybemoredependingontheworkload,a nd shallbecomposedofthefollowing:a)One(1)Bo ardCertifiedClinicalPathologistwithknowl edgeinInfectiousDiseasesandtraininginMol ecularLaboratoryDiagnosis.

4 B)Three(3)Full-timeAnalystspereight(8)ho urshift,whichshallbecomposedofEITHER three(3) RegisteredMedicalTechnologistsORtwo(2) RegisteredMedicalTechnologistsandanyalli edhealthprofessionalswithaBachelor sdegreerelevanttothejob,and withknowledge,experience,and skillsinmolecularbiologytechniques,sucha sMolecularBiologyandBiotechnology,Biolog y,AppliedBiology,Biochemistry,andMicrobi ology;c)One(1)Full-timeLaboratoryAideper eight(8)hourshift;d)One(1)Full-timeRecep tionistpereight(8)hourshift;ANDe)One(1)F ull-timeEncoderpereight(8) :a)FundamentalsofBiosafetyandBiosecurity ,whichshallcoverBiologicalRiskAssessment ,MitigationControls(engineering,practice sandprocedures,administrative),PersonalP rotectiveEquipment,specimentransport,was temanagement,decontaminationanddisposal, andEmergencyResponses(biologicalspilldri ll),ANDb) staffshallundergofittestingforrespirator withatleast95% ,newtechniquesandtechnologies, , thefollowingactivities:a)Specimenrecepti on;b)Virusinactivationand nucleicacidextraction(Pre-PCR);c)Reagent storageandhandling;d)PCR;ANDe) the floorplanchecklistforconstructingaCOVID- 19testinglaboratoryshallbe usedasreferencesinconstructingthetesting laboratory.

5 (ANNEXD1andANNEXD2).Controlledandadequat eventilationwith theprescribedairchangesperhourshallbemai ntainedfor instrumentsappropriateand consistenttothedesignatedareas.(Pleasere fertoAnnexA AssessmentToolforLicensingaCOVID-19testi nglaboratory) , beadocumentedinventoryofequipment,suppli es, servicesdeliveredtopatientscomplywiththe standardsin theAssessmentToolforLicensingaCOVID-19te stinglaboratory(ANNEXA) ,whichshallinclude,butnotlimitedto,Polic iesonBiosafetyandBiosecurity;properuseof PersonalProtectiveEquipment;SpecimenStor age,TransportandDisposal;WasteManagement ;EmergencyResponseSystem(accidents,medic alemergencies,spills,naturaldisasters,fa cilitycontainment)..Acopy(softorhardcopy )ofRITMB ioriskManagementOfficeInterimBiosafetyGu idelinesforLaboratoriesHandlingandTestin gSARS-COV-2(COVID-19) ,and theNationalExternalQualityAssessmentSche me(NEQAS)givenbyRITM.

6 [ ,recording,reportingandreleasingofthepat ient sresults,in adherencetoRepublicAct( ) DataPrivacyActof2012 11332also knownasthe MandatoryReportingofNotifiableDiseasesan d HealthEventsofPublicHealthConcernAct . ,transport, (EB)andDOHR egionalEpidemiologicSurveillanceUnit(RES U). theenvironmentissafe for itspatientsandstaff, ,and thatonlyauthorizedpersonnelshallbe 6969knownas ToxicandHazardousSubstancesandNuclearWas tesAct andotherrelatedpolicyguidelinesand/oriss uance( ). shallhaveaNotarizedMemorandumofAgreement (MOA) Incaseofequipmentbreakdownduringthe actualprocessingofspecimens,thesamplesha llbeimmediatelytransported(instrictadher encetotheguidelinesforspecimenhandlingan dtransport)toanotherCOVID-19testinglabor atory, ,the (3) ,verifiedbyaseniortechnologist, linelistformatbelow:Nameof COVID-19 TestingLaboratory:Date ofReport:HEALTHSPECIMENLABIDPATIENTNAME| AGE|SEXFACILITYTYPEPCRRESULTCOVIDID-XXXX |DelaCruz,Juan40 MHospitalANPS/OPSSARS-CoV-2viralRNAdetec tedCOVIDID-XXXX|Cruz,Gabriella60 e-mailedtothefollowing:a)b) )d) ) DOH-PTCshallbeaprerequisitein ) ,andspecialtyhospitals.]

7 Completeapplications( , GuidelinesinSecuringaDOH-PTC )shall beprocessedaccordingtotheCitizen )Onceapproved,thefacilityownerscan (DOH-LTO)1)Filingofcompleteapplicationre quirements,whethermanualoronline, ,andspecialtyhospitals; ) (ANNEXE); ; ,includingphotocopiesofvalidPRCidentific ationcard,validCOVID-19proficiencytraini ngcertificatefromRITM,andcopyofcertifica tesofallnecessarytrainings; ,reagents,andsupplies; (CPR)fromFoodandDrugAdministrationfor allequipment,reagentsandsupplies; ; ,acopyofNEQAS,CertificateofPerformancewi thPASSING results, )Afterevaluationofthesubmitteddocumentsf ortechnicalcompletenessandcorrectness,th eassignedteamfromHFSRB/CHD-RLED shallscheduleaninspectiondate,in coordinationwiththeteamfromRITM oritsdulyrecognized/authorized3 )ProcessforInspection(initialorrenewal)s hallfollowSectionVI. ,knownas RulesandRegulationsGoverningtheNewClassi ficationofHospitalsandOtherHealthFacilit iesinthePhilippines and theQualityManagementSystem(QMS) )RITM oritsdulyrecognized/authorized3" )TheDOH-LTOaCOVID-19testinglaboratorysha llbe issuedonlyafter ) )ProcessingfromapplicationtoissuanceofDO H-LTOshallbeaccordingtothe Citizen ,forbothhospital-basedandnon-hospital-ba sedCOVID-19testinglaboratory,shallbevali dforone(1) ,2019,titled GuidelinesontheAnnualCut-offDatesforRece iptofCompleteApplicationsforRegulatoryAu thorizationsIssuedbytheDepartmentofHealt h.

8 " ,uponfilingtheapplication, ,standardsand technicalassistancetostakeholder, issueDOH-LTOforCOVID-19testinglaboratori esbasedinlevels2and3generalhospitals, (RITM) the referencelaboratoryforCOVID-19testingrec ognizedbytheWorldHealthOrganization(WHO) & authorize3" Regulation,Licensing,and EnforcementDivision(CHD-RLED) issueDOH-LTOCHD-RLED sfornon-hospitalbasedCOVID-19testinglabo ratoriesand for COVID-19testinglaboratoriesbasedin Suspension/Revocation/CeaseandDesistOrde rissuedonCOVID-19testinglaboratoriesas needformoreCOVID19testinglaboratories:a) TheDOH-PTCapplicationshallbe waivedforexistingfacilitiesand shallsubmitan asbuiltfloorplan,in )All initialapplicationshallbe ,renewalforCOVID-19testinglaboratoriesin basedin )ThetechnicalassistancedonebyDOH,RITM oritsdulyrecognized/authorized3" ,compliancetotherecommendationsdonethen , )Thelaboratoriesalreadyassessedbytheteam fromHFSRB/CHD-RLED sareadvisedtoapplyforaDOH-LTO, )Teamtoconductinspectionormonitoringshal lcomefromHFSRBandRITM oritsdulyrecognized/authorized3" ,foundtobeviolatinganyprovisionoftheseru lesandregulations,relatedissuances,and otherapplicablepolicyguidelines,shallbep enalizedundertheexistinglaws, ,orinhis/herabsenceorunavailabilityorwhe ndelegated,the DirectorIIIofHFSRB,may,withinten(10) daysafterreceiptofthenoticeofdecision,fi leanoticeofappealtotheheadofthe HealthRegulationTeam(HRT).

9 Allpertinentdocumentsand recordsoftheapplicantshallthen be ,ifstillcontested,maybebroughton afinalappealtotheSecretaryofHealthwhosed ecisionshallbe issuanceis declaredunconstitutionalorrenderedinvali dbyanycourtoflaworcompetentauthority, effectimmediately.' ,MD, ,theLicensingOfficershallmakeuseof:INTER VIEWS,REVIEWOFDOCUMENTS, ,availableoradequate,placea{ ,putan(X) TeamLeadershallensurethatallteammembersw ritedowntheirprintednames,designationand affixtheirsignaturesand indicatethedateofinspection/monitoring,a llatthe lastpageof TeamLeadershallmakesurethat theHeadofthefacilityor,whennotavailable, thenext mostseniororresponsibleofficerlikewiseaf fixhis/hersignatureonthesameaforemention edpages,tosignifythattheinspection/monit oringresultswerediscussedduringtheexitco nferenceanda duplicatecopyalsoreceived.|.GENERALINFOR MATION:NameofFacility:Address:(Number&St reet)(Barangay/District)(Municipality/Ci ty)(Province&Region)Telephone/Fax :Initial:Renewal:ExistingLicenseNo:DateI ssued:ExpiryDate:NameofOwnerorGoverningB ody(ifcorporation):NameofHeadofLaborator y:ClassificationAccordingto:Ownership:__ Government__PrivateFunction:__COVID-19 TestingLaboratoryInstitutional-Character :_Hospital-Based__Non-hospital-basedServ iceCapability:|Add-onservicetoGeneralCli nicalLaboratory___LimitedServiceCapabili tytoCOVID-19 TestingDOH-COVID19-LTO-ATRevision.}

10 0004/07/2020 Page1of13 'smanagementteamprovidesleadership,actsa ccordingtotheorganization'spoliciesand has overallresponsibilityfor theorganization'soperation,and thequalityofits servicesanditsresourcesOrganizationalStr ucture/ChartObserve ,visionandobjectivesshallbein accordancewithRA4688 DocumentRevieweWrittenvision,mission,and goalsObserveeVision,mission,andgoalsdisp layedina conspicuousareavisibletoclientsLicenseto operateand otherdocumentsDocumentReview CompilationofClinicalLaboratoryAOs,Repor tofInspection/MonitoringObserveeValidDOH -LTOpostedinaconspicuousareavisibletocli entsAdministrativeandtechnicalmonitoring andEvaluationactivitiestoassessmanagemen tandorganizationalperformanceDocumentRev ieweSupportingdocumentsforevaluationandm onitoringofactivitiessuchasrecords,logbo oks,checklistofsupplies,inspectionreport ,purchasingorprocurementandacceptanceofs upplies, ConductofDocumentReview Compilationofminutesofregularstaffmeetin gsmeeting(reflectingthedate,time,heldatl easttwiceayear]attendance, |DocumentReviewcomplaintsand clientfeedbackeWrittenprotocolforhandlin gcomplaints/clientfeedback.)


Related search queries