Address: Numberstreet Barangay/Municipality

ASSESSMENTTOOLFORLICENSINGABLOODSTATION

NameofBloodStation:

Address: NumberStreet Barangay/Municipality

Province/CityRegion

ContactNo./FaxNo./E-mailAddress:

Applicationfor:Initial

RenewalATONo:

DateIssued: ______ExpiryDate: ______

GENERALINFORMATION:

NameofOwnerorInstitution:

NameofHeadofBloodStation:

Classificationaccordingto:

Ownership: / Government / Private
InstitutionalCharacter: / Hospital-based / Nonhospital-based

Instructions:

(1)Encircle(+)ifitemindicatedispresent,and(-)ifitemindicatedisabsent/presentbutnon-functional. (2) Allitemswith(*)shallbe postedinaconspicuouslydesignatedarea.

(3)Thistoolmayserveasaguideforself-assessmentofthefacilityinpreparationforinspection/

monitoringvisits.

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STANDARDSANDREQUIREMENTS / REFERENCE / FINDINGS
ApplicationDocuments
•Documentary requirements properly filled up andvalid(refertoapplication)
•Certificatesandrequiredformsduly accomplishedandvalid(refertoapplication) / (+)(-) (+)(-)
1. MANAGEMENTREQUIREMENTS
1.1.ManagementResponsibility
TheBloodStationshallbemanagedeffectively and efficientlyandinaccordance withitsvision,mission,and objectives.
1.1.1. There shall be a continuing program on staff developmentandtraining.
1.1.1.1. Proofoftrainingthroughrelevantcertificates, memos,writtenreports,budgetary allocations, etc.
1.1.2. Thereshallbeapolicyforhiring,orientationand promotionforalllevelsof personnel.
1.1.2.1. Documented procedure/processonhiring, orientation andpromotionofpersonnel atall levels
1.1.3. Thereshallbeapolicyfordiscipline,suspension, demotionandterminationofpersonnelatall levels.
1.1.3.1. Documentedprocedure/processondiscipline, suspension, demotionandterminationof personnelatall levels / (+)(-)
(+)(-)
(+)(-)

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STANDARDSANDREQUIREMENTS / REFERENCE / FINDINGS
1.2.Manpower
TheBloodStationappointsandallocates personnel who aresuitablyqualified, skilledand/ortrainedtoassumethe responsibilities,authority,accountability, andfunctionsof theposition.
1.2.1. Theorganizationalchartshallbe clearlystructured.
1.2.1.1. Organizational chart* clearly structured indicating thenameswithpicturesand designation, reflectinglinesofauthority, accountability, communication,inter- relationship,hierarchy offunctionsandflowof referrals
1.2.2. Dutiesandresponsibilitiesshallbeclearlyspelled out.
1.2.2.1. Documenteddutiesandresponsibilitiesofall
BloodStationpersonnel / (+)(-)
(+)(-)
1.2.3. The Blood Station is headed by a duly licensed physicianand:
Forhospital-basedBloodStations:
•CertifiedinClinicalPathologybythePhilippine
Societyof Pathologists(PSP),OR
•Physician authorized to head the clinical laboratory ofthehospitalwheretheBlood Station islocated (inareas wherepathologists arenotavailable)
Fornonhospital-basedBloodStations:
•Physicianwithatleastthree(3)monthsformal traininginbasicbloodbankingrecognizedby theDOH-NVBSP,OR
•Physicianwithatleastone(1)yearonthejob experience inaBloodBank/Centerrecognized bytheDOH-NVBSP / (+)(-) (+)(-)
(+)(-) (+)(-)
1.2.4. Thereshallbeadequatenumberof qualifiedmedical technologistswhoshallworkonshiftstocovera
24-hour service proportional to the workload as determinedbytheheadoftheBloodStation.
1.2.4.1. Proofof training / (+)(-)

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STANDARDSANDREQUIREMENTS / REFERENCE / FINDINGS
1.2.5. TheBloodStationshalldesignateandtrainone(1) medicaltechnologistas a Quality AssuranceOfficer. Suchtrainingshallberecognized bytheDOH- NVBSP.
1.2.5.1. Proofof training / (+)(-)
1.3.PHYSICALFACILITIES/WorkEnvironment
Servicesareprovidedinanenvironment thatpromotes safety,hasadequate space,meetstheneedsofclients, serviceproviders andotherstakeholders,andconforms to thecurrentManualofStandardsissuedbytheDOH.
1.3.1. The Blood Station has adequate space for the conductofitsactivities.
1.3.1.1. Ocular inspection demonstrates adequate spacefortheequipment, furniture,storageof glassware, reagentsandsuppliesandthe activitiesof the BloodStationstaff
1.3.1.2.Work area accessible to Blood Station personnelonly / (+)(-)
(+)(-)
1.3.2.TheBloodStationshallbeadequately ventilated, well-lighted,clean,safeandfunctionalbasedonthe servicesitprovides.
1.3.2.1. Ocular inspection demonstrates good ventilation, lighting,cleanliness withnoriskof physicalandchemicalhazards / (+)(-)
1.3.3. Thereshallbe aprogramofpropermaintenanceand monitoringofphysicalplantandfacilities.
1.3.3.1. Documented program for the proper maintenance andmonitoringofphysicalplant andfacilities / (+)(-)
1.3.4. Thereshallbeapolicyonlaboratorybiosafetyand biosecurityand for the properdisposalofwasteand hazardous/infectioussubstancesthatshallconform tothestandardssetbytheDOH.
1.3.4.1. Documentedprocedure/processonlaboratory biosafety andbiosecurity andfortheproper disposalofwasteandhazardous/ infectious substances / (+)(-)

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STANDARDSANDREQUIREMENTS / REFERENCE / FINDINGS
1.4.EQUIPMENT
Allequipmentandinstruments necessaryforthesafeand effective provision ofservicesareavailableandare properlymaintained.
1.4.1. There is an adequate number of operational equipment toprovidetheBloodStationprocedures theBloodStationis licensedfor.
1.4.1.1. EquipmentlistedavailableintheBloodStation
1.4.1.2. Provisionforpersonalprotectiveequipment / (+)(-) (+)(-)
1.4.2. There is a program for calibration, preventive maintenanceandrepairfortheequipment.
1.4.2.1. Recordofscheduleofcalibrationand maintenanceof equipment
1.4.2.2. Recordofreportsofpreventivemaintenance andrepair / (+)(-) (+)(-)
1.4.3. Thereshallbeacontingencyplanincaseof equipmentbreakdown, especially ofBloodStation coldstorageequipment.
1.4.3.1. Documented contingency plan in case of equipmentbreakdown / (+)(-)
1.5. REAGENTSANDSUPPLIES
Allreagentsandglasswaretobeused bythebloodstation shallbebasedontheminimumrequirement forsensitivity andspecificity oftestingreagentsaswellasthetesting proceduresasrecommendedbythetechnicalcommittee oftheNVBSP(forhospital-basedBS).
1.5.1. Thereisanadequatesupplyofproperlystoredand inventoriedreagentsandsupplies.
1.5.1.1. Quality recordsofreagents/ supplies,their usage/ consumption and disposal are available / (+)(-)
1.5.2. There are adequate storage facilities such as refrigeratorsforperishablereagentsandsupplies.
1.5.2.1. Temperaturemonitoringrecords / (+)(-)

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STANDARDSANDREQUIREMENTS / REFERENCE / FINDINGS
1.6. REPORTINGANDRECORDSMANAGEMENT
There shall be a system of reporting and recording of storedandissuedbloodandbloodproducts.
1.6.1. There shall be a documented procedure for reporting andrecording ofstoredandissuedblood andbloodproducts.
1.6.1.1. Logbooks/ recordsofstoredandissuedblood andbloodproducts
1.6.2. There shall be a documented procedure for retention ofrecords whichshallfollowstandards promulgated bytheDOHand/orcompetent professionalorganizations.
1.6.2.1. Fileof retainedrecords
1.6.3. Thereshallbeadesignatedareaforstorageof records.
1.6.3.1. Storageareaadequateforrecordkeeping
2. TECHNICALREQUIREMENTS
2.1. Administrative/TechnicalProcedures
Thereshallbeasystemforstorage,provision,andproper issuanceofsafeandtestedbloodandbloodproducts.
2.1.1. Thereshallbeapolicyonstorageandissuanceof bloodandbloodproducts.
2.1.1.1.Documented qualityprocedures forproper storage,andissuance ofbloodandblood products
2.1.1.2. Recordson storageand issuanceof bloodand bloodproducts
2.1.2. Thereshallbeapolicyforcompatibilitytestingfor hospitalbasedBS.
2.1.2.1. Documented quality procedures for compatibilitytesting
2.1.2.2. Recordsof resultsforcompatibilitytesting / (+)(-)
(+)(-)
(+)(-)
(+)(-) (+)(-)
(+)(-) (+)(-)

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STANDARDSANDREQUIREMENTS / REFERENCE / FINDINGS
2.2. QUALITY ASSURANCEPROGRAM
The Blood Station shall put into practice quality a assuranceprogram.
2.2.1. There shall be a policy on Quality Assurance
ProgramandContinuousQualityImprovement.
2.2.1.1. DocumentedInternal Quality Assurance ProgramincludingInternalQuality Control and ContinuousQualityImprovement
2.2.1.2. Results/findingsofQualityAssuranceaudits/
assessments / (+)(-)
(+)(-)

LISTOFEQUIPMENT/INSTRUMENTS

BLOODSTATION

I.NON-HOSPITAL-BASEDBS

1.Air-conditioningunit

2.Autoclave

3.Automaticemergencylight

4.Computerwithprinter,UPS,AVR(optional)

5.Fireextinguisher

6.Generator

7.Refrigerator

7.1 Bloodbankrefrigeratorcontrolledat2-60C withtemperature recorderandalarmsystem,andAVR

8.Thermometer

8.1 Laboratorythermometer

8.2 Roomthermometer(optional)

II.HOSPITAL-BASEDBS

Allthosestatedaboveplus:

1.Agglutinationviewerforcompatibilitytesting

2.Serologicalcentrifuge

3.Waterbathat 37°C

Republic of the Philippines

Department of Health

HEALTH FACILITIES AND SERVICES REGULATORY BUREAU

NameofFacility :

Date of Inspection:

RECOMMENDATIONS:

For Licensing Process:

[ ]For issuance of Authority to Operate asBlood Station.

Validity from to

[ ]Issuance depends upon compliance to the recommendations given and submission of the

following within days from the date of inspection:

[ ]Non-Issuance: Specify reason/s.

Inspected by:

Printed Name / Signature / Position/Designation

Received by:

Signature

Printed Name

Position/Designation

Date

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NameofHealth Facility :

Date of Monitoring:

RECOMMENDATIONS:

For Monitoring Process:

[ ]Issuance of Notice of Violation

[ ]Non-issuance of Notice of Violation

[ ]Others (Specify)

Monitored by:

Printed Name / Signature / Position/Designation

Received by:

Signature

Printed Name

Position/Designation

Date

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