A.O.No. 2021 -_0037_ Republic of the Philippines ANNEXE! Department of Health ASSESSMENT TOOL FOR LICENSING A GENERAL CLINICAL LABORATORY INSTRUCTIONS: 41. To propery filloutthis tool, the Licensing Officer shall make use of: INTERVIEWS, REVIEW OF DOCUMENTS, OBSERVATIONS and VALIDATION of findings. 2. If the corresponding items are present, available or adequate, place a ( on each of the appropriate spaces under the COMPLIED column or space provided alongside each corresponding item. If not, put an (X) instead. 3, The REMARKS colimn shall document relevant observations. 4, Make sure to fill-in the blanks with the needed information. Do not leave any items blank. Put N/A if Not Applicable. 6, The Team Leader shall ensure that all team members write down their printed names, designation and affix their signatures and indicate the date of inspection/monitoring, al at the last page of the tod. 6. The Team Leader shall make sure that the Head of the facilty or, when not available, the next most serior or responsible officer likewise affix his/her signature on the same aforementioned pages, to signify that the inspection/monitoring results were discussed during the exit conference and a duplicate copy also received, GENERAL INFORMATIO! Name of Facility: WH trea dy iu ~ FMerman mal vi ; a Complete Address: et em Au La-t tm eh Numbers Steet a Vonyos District 2 Matawan _fiby icbaliyiy FannelRenon —Vigreauien son. ¢h Contact Information; _ PALOANSAS% [04171824 31U4 Email Address: homalavm @ Weeigin Initial VM Renewal 01 Existing Leers. wah Datetssued: 1 Expiry Date: We Name of Ovmer or Governing Body (if corporation). Sinvise MicAta\ baw» Wwe Name of Head ofLaboratoy: DR: MALICEY Trey Classification According to: Ownership: © Government 5 Private Function: ical Pathology © Anatomie Pathology D Molecular Laboratory 1D stitution-based Specify Institut Sewice Capebity Primary ° testy Institutionai-Character; im Nominstitution Based © Secondary ©. Limited-Service Capability © Tertiary © Mobile Clinical 7 Donnrere copa cisa|COMPLIED minutes of meeting reflecting the date, time, attendance, agenda, and action taken signed end approved by head of laboratory * Supporting documents for evaluation and monitoring of activities such as_ records, logbooks, checklist of supplies, inspection report, purchasing or procurement and acceptance of supplies, etc, i CRITERIA: ‘INDICATOR/EVIDENCE 1. ORGANIZATION AND MANAGEMENT ‘The organization's management team provides leadership acts according to the organization's policies and has overall responsibility in ensuring effective and efficient operation of the organization| (clinical laboratory). 1. There is an Observe organizational » Updated organizational chart is ‘structure that posted/displayed in ‘ clearly reflects conspicuous area with the the line of names, latest pictures (at least authorities, passport size) and designation accountability, communication, interrelationship, hierarchy of functions and flow of referrals 2. The Document Review organization's ‘* Written vision, mission, and i mission, vision goals and ol ti shall be Observe accordance with | « Vision, mission, and goals, RA 4688 posted/displayed in a conspicuous area visible to clients 3. The organization | Document Review has a valid ‘Compilation of Clinical 7 DOH-LTO and Laboratory AOs, Reports of other pertinent Inspection/Monitoring documents Observe * Valid DOH-LTO posted in a conspicuous area visible to clients 4. There isa policy | Document Review and procedure ‘© Written policy on management ‘on management review : review * Compilation of documented AY ‘DOH-HFSRE-OOFOT-CLG-AT Resin: 00 patosF ——r r ‘CRITERIA !cINDIGATORIEVIDENCE: © |COMPLIED %. Therels policy | Document Review and procedure | + Written policy and procedure for handling for handling complaints/client 1 complaints and feedback client feedback '* Suggestion box visible to clients i ‘* Forms for complaints/ client i feedback ‘© Records of comptaints/ client feedback and actions taken. L il. HUMAN RESOURCE MANAGEMENT A. STAFF RECRUITMENT, SELECTION, APPOINTMENT AND RESPONSIBILITIES: 6. Thereis policy | Document Review and procedure | + Written policies and forhiring, procedures on hiring, orientation and ‘orientation and promotion of / promotion for all Personnel at all levels. levels of personnel 7. There is policy __| Document Review and procedure | « Written policies and ! on continuing procedures for staff programforstaff | development and training development + Proof of training through ! and training relevant certificates, memos, written reporis, budgetary allocations Interview ‘© Human Resources Management Officer! Personnel Officer &. Thereis policy __| Document Review and procedure | « Written policies and procedures for discipline, on discipline, suspension, | suspension, demotion and ‘termination of demotion and personnel at all evels termination of personnel at all levels. B. PERSONNEL 9. The dullesand | Document Review responsibilities | + Written job description or dues. shall be clearly and responsibilities of all| / stated laboratory personnel 10. There is an Document Review adequate * List. of Personnel with | number of designation qualified * Area of assignments indicated personnel with in the posted work schedule | / documented iPCOMPLIED. : TF : = CRITERIA“ |)” INDICATOR/EVIDENCE uk ‘training and signed and approved by head of ‘experience to laboratory ‘conduct/perform * There is a policy whenever : the laboratory there is an increase in procedures workload, there shall be a corresponding increase in the number of personnel + There is a policy on hiring or designating additional personnel as: + Proof of attendance + Proof of _ qualifications (please refer to specific igned by the head of the government facility, applicable (AO. # 92 s. 2003) 11. There is policy on the Document Review ‘© Proof of submission of datato implementation NDHRHIS of National Database of Human Resource for Health Information ‘System (NDHRIS) 72-Each personnel _| Document Review shail have a * Updated 201 files ofall 1 record of updated | laboratory personnel 201 files ‘A. The Head of the | Document Review Laboratory © Proof of supervisory visits. at (HOL) shall least once a week for physical have the overall | __ visit OR once a month physical | / supervisionon | visit with at least twice a week technical of. supervisory calls and/or procedures as video conferencing wellas onthe | © For HOL of hospital-based administrative clinical laboratory: supervisory laboratory physical visits of at least once a management week © Proof of qualifications: + Updated resume + PRC certificate and valid PRC ID + PSP Board Certificate + Certificate of Good Standing from PSP + Notarized employment contractCRITERIA INDICATORIEVIDENCE == | COMPLIED REMARKS. + Relovanttraining certificates (e.g., Molecular Pathology) + Annual medical certificate and proof of immunization (Hepatitis 8 and influenza) ‘Qualification of Head of Laboratory Certified CP _[ Certified AP ‘A. Clinical Laborator 4,_ Primar T 2. Seconda T 3. Tertiary T “4. Limited™ B. Anatomic Laborato C. Molecular Laborator 1. Genetics™* 2._Immunohematolo; L '3._Infectious L “Tt will depend on the limited services to be provided Remarks. **A pathologist or a licensed physician who is trained in the management, principles and methodology of these specialized services that are being provided shall head this type of laboratory CRITERIA INDICATOR/EVIDENCE | COMPLIED REMARKS: B. Registered | Document Review Medical * Proof of qualifications: ! Technologist + Updated resume (RMT) + PRC certificate and valid PRG ID (Atleast 1 + Relevant training certificates competent + Notarized employment RMT per contract assigned area) | «Annual medical certificate + Proof of immunization (Hepatitis B and Influenza) RMT staff with designated gssignments, as | Adtfonal proof of trainings applicable: rane acamcneotente 2. AFB microscopy] * Ceflete of traning on DSSM * Certificate of traning in 3. Bacteriology bacteriology (RITM and other RITM recognized institutions) 4, Malaria smear | * Celtficate of training in malaria smear (RITM) DOH FERS ORO AGAT ceiaat Siete5. Others. C. Biosafety and Biosecurity Officer (May be designated by the HOL) Document Review ‘© PRC certificate and valid PRC ID (RMT) © Certificate of training in Biosafety and Biosecurity (RITM and/or UP-NTCBB) Staffing Pattern for RMT Analysts 4. Clinical Laboratory for Clinical and Anatomic Pathology PRIMARY SECONDARY TERTIARY SERVICES ee pa ee shin_| shim | stin_| shin | shin | shin | shin | shin] shin Microscopy sf steer 0 [eine faethe ‘Hematology ete fet ea | atest Clinical Chemistry i Stas sce |e | seen) eee et immunology/Serology ; 7 1 ‘Microbiology ; | Histopathology 1 BFF relieven without TE(TTT raliever) Microbioto without Histopathot Total a@etratoveytor | 12(tt+tralever) | NERD tratoven tor ‘Government Faciltios Hospltal-Based Note: An increase in work Shall require a corresponding Increase in the number of personnel 2. Clinical Laboratory for Anatomic Pathology ~ At least one RMT per section 3, Clinical Laboratory for Molecular Pathology ~ Will depend on the services offered EB CRITERIA INDICATOR/ EVIDENCE COMPLIED REMARKS PHYSICAL PLANT, FACILITIES, AND WORK ENVIRONMENT. 13. There is Document Review program of ‘© Written policy and programfor | proper the proper maintenance and maintenance monitoring of physical plant and ‘and monitoring facilities of physical plant | « Proposed schedule for 1 and facilities preventive maintenance oe * Updated proof of actual implementation of maintenance as to structure, ventilation, lighting & water supply 7a. There are policy| Document Review guidelines on Local risk assessment reviewed is laboratory, at least annually biosafetyand | © Written protocols on taboratory | biosecurity biosafety and biosecurity Observe * Good Laboratory Practice that. includes use of Personal 7 1 (oma Base eatersCRITERIA INDICATOR / EVIDENCE REMARKS COMPLIED Protective Equipment and other precautionary measures 15. There isa policy | Document Review and procedure | Policy on disposal of wastes forthe proper that conformwith Healthcare 1 disposal of Waste Management Manual, waste and and RA No. 6969 hazardous/infect | » Notarized Memorandum of jous substances | Agreement (MOA) with , that shall infectious waste, toxic, and conformto the hazardous substances hauler standards set by the DOH Observe * Proof of proper management of wastes from point of generation, segregation (color-coded waste bins), disinfection, up to the final disposal NOTE: Please see the reference plan/physical plant (Annex Di and D2) Iv. EQUIPMENT /INSTRUMENTS: 16. Theres an jocument Review adequate ‘© List of available and functional number of laboratory equipment ! operational equipmentto | Observe provide the ‘All laboratory equipment and laboratory instruments are operational examinations that the laboratory is licensed for 77. There is Document Review program for * Regular schedule including calibration, frequency of preventive | / preventive maintenance and calibration maintenance | « Updated certificate of calibration ‘and repair for and maintenance of equipment / the equipment. | + Record of repair reports 78. There is Document Review contingency plan | « Written policy on contingency in case of plan in case of equipment | / ‘equipment breakdown breakdown V. REAGENTS AND SUPPLIES 79. There is an Document Review ‘adequate supply | * Quality records of supplies of properly Ireagents with expiration date, 1 stored and their usage/ consumption and inventoried disposal are available reagentsand | « Certificate of | Product supplies for the Reaistration __ from __FDA. f “77 ‘DOH-HFSRS-GOFOT cLGAT papreae apetorsCRITERIA ‘:INDICATOR/ EVIDENCE | COMPLIED REMARKS Taboratory including thereagents, supphes, examinations to | and equipment used for POCT be provided. and MCL Observe ‘* Availabilty and completeness of reagents and supplies ‘+ Validate the expiration dates of reagents 20. The reagents | Document Review and supplies are © Records of temperature storedunderthe | — monitoring as follows: required + Room temperature reading conditions with + Refrigerator and freezer ‘adequate temperature reading storage facilities such as Observe refrigerators for | © Monitoring of room temperature perishable + Temperature of refrigerators (2°C| reagents and to B°C) and freezers (-20°C to- supplies 30°C) 21. There is an Document Review ‘appropriate ‘* Material Safety Data Sheet storage (MSDS) available for all | / area/technique reagents/supplies and for flammable, accessible to all personnel at all combustible and | times hazardous chemicareagen | Observe ts ‘* Organized per section with National Fire Protection Association (NFPA) Label or its equivalent VI. ADMINISTRATIVE AND TECHNICAL POLICIES AND PROCEDURES 22. There is an ‘administrative policies & procedures for provision of laboratory services and for the operation and maintenance of the laboratory Document Review * All documented policies, protocols, procedures are signed and approved by the head of laboratory ‘+ Guidelines in the operation and maintenance of the laboratory Including policy on security of supplies, specimens and confidentiality of records * Laboratory services. and corresponding prices. are accessible to the public 23, The technical procedures of services provided by Document Review © Documented and updated policies and procedures of laboratory services in each of the sections/areas. Rovio 09 74 d ‘DOH-HFSRS-OOPOT-CLG-ATCRITERIA. “ANDIgATOR EVE ce COMPLIED each section are | » Documented policies, protocols, / available and guidelines in the operation and maintenance of the laboratory ‘A, Communication and Records 24. There are Document Review proceduresforthe] « Documented procedures for receipt and receipt and performance of | / performance of laboratory tests laboratory tests 5. There are Document Review proceduresfor | Documented procedures for reporting of reporting of results of laboratory | / results of tests laboratory tests | » Documented procedures for the validation of laboratory results prior to reporting 26. The laboratory | Document Review reports on «Laboratory report forms bearing various the name and originaldigita | / examinations of signature with PRC ID No. of the ‘specimens: head of the laboratory and the A. shall bearthe | RMT analysts name ofthe | * Updated records of resut pathologistor | (logbooks/ electronically stored designated data with back up) including associate entry, releasing & endorsement whoshallbe | records. responsible | « There is a policy guideline on forthe the use of authenticated | / rellabliity of electronicidigital signature that the results is in accordance with the E- B, The reports commerce law shall also * Documented policy —_for | bear the Laboratory Information System, name of the if available RMT(s) who. performed the examinations and duly ‘signed by thavthose person(s) ‘27, There are Document review procedures for » Documented procedures for Teporting of reporting of workload, quality | / workload, quality control, inventory control, etc. control, ‘* Updated reports and docurrents inventory (hard or soft copy with back up) | / control, etc. * Worksheets/machine print out per section as proof of actual | performance DOn-HFERG- COROT GLOAT "Revie 0 sagt28. There is a Document review procedurefor |» Documented procedures for reporting and reporting and analysis of analysis of incidents, adverse events, etc. incidents, * Compiled of written reports with adverse events, | — resolutions and other related process. 25. There is a Document review documented ‘+ Documented procedure for the procedure on retention of records which the retention of follows standards promulgated documents, by the DOH records, slides, | © Compiled laboratory tests and specimens results, whether logbook or of the clinical electronically stored laboratory which shall follow standards promulgated by the DOH (DC# 70s, 1998) professional organizations B. Quality Assurance 30. There is a policy on Quality ‘Assurance Program (QAP) ‘and Continuous Quality Improvement Document review * Documented intemal QAP including Internal Quality Control and Continuous Quality Improvement ‘* Updated Quality Control reports conducted per tests and filed accordingly + Availability of reference materials and appropriate Teagents & equipment used * Resultsffindings of Quality Assurance audits / assessments Bi. There is a proof of participation in Extemal QAP (EQAP) that may be administered bya designated NRL or other local and international EQAP approved by the DOH Document review ‘© Documented procedure in the actual performance of EQAP activities ‘+ Certificate of Performance it EQAP with passing rate C. Referral or Outsourcing of Laboratory TestsCOMPLIED, 32. There isa policy on referral and outsourcing of examinations Document Review * Documented procedures on referral and outsourcing of examinations to other DOH licensed clinical laboratory «Records of outsourced ‘examinations (in the event of machine breakdown) * Notarized Memorandum of Agreement + DOH-LTO of referral testing laboratory Vil. POINT OF CARE TESTING: (poct), 33. There is a policy on POCT Document Review * Documented list of POCT operators, machin instruments and kits + Documented procedure on the conduct of periodic assessment by representatives fromthe top management, clinical laboratory, clinical departments ‘and nursing service, to evaluate the policy of the clinical laboratory on POCT. NIA ‘vi. MOBILE: ‘GLINICAL LABORATORY. ‘34. There isa policy ‘on Mobile Clinical] » Documented Procedures on Laboratory Document Review + Collection of specimens + Processing of specimens © Land Transportation Office Registration (proof of ownership) * File of Memorandum of ‘Agreement between the clinical laboratory end the facility where the mobile activity Is conducted NIA PHT onHFsRE coma eLo-T "ae ofitsRepublic of the Philippines Department of Health HEALTH FACILITIES AND SERVICES REGULATORY BUREAU Name of Facily: i= Prtrisen Dio nosis ~ MSvermayi wt Date of Inspection: RECOMMENDATIONS: For Licensing Process tl For Issuance of License to Operate as: Validity from to Issuance depends upen compliance to the recommendations given and submission of tho a following within days fromthe date of inspection. 01 Non-issuance. Specify reasons: Inspected by: hich Nactine ABun-fi Qe Ponts Super e Printed Namo signature PstlonDesgnston Received by: Signature: Printed Name: Position/Designation: Dat ‘DOM-HFGRS-GOROL-CLG-AT ‘Roisin: 09 aaa page tearRepublic of the Philippines Department of Health HEALTH FACILITIES AND SERVICES REGULATORY BUREAU Name of Facility: Vilred sin Olagnedstus = Boner mal Warglonn Date of Monitoring: RECOMMENDATIONS: For MonitoringProcess tl Issuance of Notice of Violation 11 Nomissuance of Notice of Violation. tl Others. Specty: Monitored by: Jit Naciiny §- Burs ib Banc Gapenitnrr Usinatine Printed Nome Pslon/Designstion Received by: Signature: Printed Name: Position/Designatio Date: DonnFeRo-coro: OAT rover 68 espe dartsRepublic of the Philippines Department of Health A.O. No. 2021 -_0037 ANNEX B2 HEALTH FACILITIES AND SERVICES REGULATORY BUREAU EQUIPMENTINSTRUMENTS/GLASSWARE/SUPPLIES/REAGENTS PER AREA OF _ACTIVITY/SERVICE CAPABILITY OF GENERAL CLINICAL LABORATORY (Place a Von spaces provided before each iter if available ‘and ifnot or NA for Not Applicable} ACTIVITY. SERVICES® | GLASSWARE AND SUPPLIES REMARKS: 70% Alcohol ZCottons Tourniquet Facet Blood Capillary Tubes Extraction L Labeling Materials Test Tubes T Sterle Medica tepe ‘TSyringo and Neodle-eny gauge ‘SPECIMEN (Crplation bat) COLLECTION 4 Puncture Proof Sharps Container Applicator Stick X_ Specimen container wi cover or Other Body ‘Screw Cap (cml) Fluids (Urine, Stool, Sputum, | x_ Sterile Screw Cap Specimen ete.) Container, if applicable “x. Plastic ealibrated loop and other necessary materials, f applicable | Non-Mercurial Thermometer: (Reem ‘tran tiga) OTHER Refrigerator (samples/reagents) EQUIPMENT 7 Fro Extinguisher (Cen 6) | Z spins EQUIPMENTT SERVICES INSTRUMENT / (REAGENUE, eS. GLASSWARE/SUPPLIES ical Microscopy Supplios / Slides Tost tubes rom) Zcover Sips TTest Tube Rack Larplicatr sticks Urine Strips ‘4 parameter Manual Z10- parameter URINALYSIS: YZ Clinical Centrifuge 2,000 omy Controls {Z Microscope (einocular Norms Eempoine) Z Patniege — Automated | ~_Stip Reader Utne Analyzer ay DOSSHFSRE GAT Arex ace Page tetEQUIPMENT? ‘SERVICES INSTRUMENT / REAGENTS: REMARKS GLASSWAREISUPPLIES |_ “So ofErin) Seeenemen WETSMEARFOR | Supplies ‘Trichomonas L Slides ‘Test tubes (1000 a Cover Slips: LNormal Saline Test Tube Rack Spun STOOL ANALYSIS. | —¥ Applicator slicks ‘Lugot’s todine L Microscope (rocuer Eemgouna) PREGNANCY TEST | / Pregnancy test kt FECAL OGGULT BLOOD. L Occult blood test kt ‘Special Taste: For — | odeaa Ws Tar DOH identifies endemic areas only(e.,, Kato Katz, ‘Schistosomiasis, Malaria smear, Faria ‘smear, rapid plasma regain for syphilis) Hematology —Manuat , ~_Spectrophotometer ors | RagoNCeOON,, HEMOGLOBIN quivalent Hemoglobin) —-Cuvettestast tubes L Sahivmicropipette £ Standard L Manual tomato Cenuge HEMATOCRIT Hematocrit Reader Capillary Tube Sealer a Manual ZRBC Diuent RED BLOOD CELLS | ""/ Microscope ‘Other reagent (©pional) Compound) a Peta Shaker ware BLOOD eG misoppete | -LW8CDIvent ea “LCounting Chamber w! vuareercour | Hic wee / micropipette Z (@santtve) SL Pet Dish (enero) | “Platelet vont — - Hennral J ~, Differential Counter eee DIFFERENTIAL Slides Baring Kt ‘COUNT Z Staining Glasses ee Zwierescope iioeior Compound) ye 4 ‘DOBNFERE-CLGAT Amana ReonEQUIPMENT SERVICES INSTRUMENT / REAGENTIS REMARKS GLASSWARE/SUPPLIES | Ts Not of xrta) bees s/c “Z Diwonts lyse = Gteanse Solution compere BLoo | __ Automates other Reagents couNT TU Hematotogy Analyzer Controls ated Zio T,Serotage offs equrvarent Clee ibes 4 Normal Satine FonwaRD AND | / Manual Sone en REVERSE ABO imo GROUPING ANDRN | + semi-automated machine | reagents (D)TYPING cue | > 1 Blood Typing Metos) a 4. Automated ‘ailtional Services for Secondary Calegory COAGULATION | _X Coagulation Machine “Coagulation STUDIES ~for E Calbrated Pipettes Reagents hospitalbased | “x Cuvettes orite equivalent | __Contols Clinical Chomistry ROUTINE: Blood Glucose (ras/ Res/ocTT) Total Cholesterot Triglycerides: HDL Blood Urle Acid Blood Creatinine Blood Urea Nitrogen “Refrigerator (ample ard ‘epaent) £ Clinical Centrifuge Water Bath or its equivalent 4 Coliorated Pipette tips @ Other Pipates Timer Lcuvettes Test Tubes T Test Tubes Rack ipeties Manual T Spectrophotometer ots ‘quivatont — Automated T_ Chemistry Analyzer Ldistod Water Standard Gaitrator Controls ‘Normal Zrsmasge io Reagents ee Zcreatinine Wes L Ora! Guicose Tolerance Drink ‘Additional Services for Sacondary Category ELECTOLYTES (Na, KCl) —Manuat Automated Analyzer “_ Standard! Calibrator Controls — Noma SPatetoge py fen ‘eats, SoestEQUIPMENT7 aeN REAGENTS REMARKS SERVICES INSTRUMENT / GuAINSTRUMENT! | ctuensectomin | _ (antiyinecnnend “£ Tost Reagents ast Ie at ES ZAs Ee anal Sarda Tor Tari ODOT ther Clea aaa Chemisty Zainater Examinations _X Manual ARTERIAL BLOOD ltd Bone 8 7, ARTES ape) ctor | woihatamated Aneyzer | Palace poaplicees mia __ Test Reagents ‘ramunology / Serology ae ZFeuttobes Test Tubes Rack = Stenderd! “ZGless Pcs aa # gasie serococte |ZPwatue Rib Shears T Toothed Forceps EWeiching Seale Molecular Pathology Z Disiied Water Indes Sess Ciincal Centrtuge XL Retigerator “pcr ‘<_Other Machines/Equipman! Supplies Test Reagents Note: These are the list of minimum requirements as to equit ire media, supplies & glassware’s, Additional services are acceptable provided that appropriate items mentioned with technical procedures, na available, if necessary. (Please use additional sheet of paper, if needed.) DO HFSRO-CLEAT Area ayant eieere