A.O. No. 2021 -_0037. Republic of the Philippines el Department of Health HEALTH FACILITIES AND SERVICES REGULATORY BUREAU ASSESSMENT TOOL FOR LICENSING A GENERAL CLINICAL LABORATORY INSTRUCTIONS: 1. To propery filroutthis too}, the Licensing Officer shall make use of: INTERVIEWS, REVIEW OF DOCUMENTS, OBSERVATIONS and VALIDATION of findings, 2. Ifthe corresponding items are present, available or adequate, place av") 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 column shall document relevant observations. 4, Make sure to fillin the blanks with the needed information. Do not leave any items blank. Put N/A if Not Applicable. 5, The Team Leader shall ensure that all team members write down their printed names, designation and affix their signatures and indicate the date ofinspection/monitoring, all atthe last page ofthe tod. 6. The Team Leader shall make sure that the Head of the facilty or, when not available, the next most senior 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 recelved. GENERAL INFORMATION: Name of Facility, Complete Address: Number& Street Barangay/Ditict ‘Municpalty/Gxy Province/Region Contact Information: E-mail Address: Initial tl Renewal tl Existing License ain Date Issued Expiry Date: Name of Owner or Governing Body (if corporation): Name of Head of Laboratory: - Classification According to ‘Ownership: 2 Government O Private Function: (Clinical Pathology 3 Anatomic Pathology 0. Molecular Laboratory Institutional-Character: Non-Institution Based 2 Institution-based Specify institution: Service Capabilty > Primary BGR Based Progam Secondary _ Limited-Service Capability © Tertiary 2. Mobile Ciinical Laboratory rH 4 ‘DOH HFSRB.GOA-CLG-AT "Revion 02 ‘Sett Paget ot 13CRITERIA INDICATOR/EVIDENCE Jeourueo : 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). 7. 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 accountabi communication, interrelationship, hierarchy of functions and flow of referrals 2. The Document Review organization's * Written vision, mission, and mission, vision goals and objectives shall be in 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 DOH- LTO and Laboratory AOs, Reports of other pertinent Inspection/Monitoring documents Observe + Valid DOH-LTO posted in a conspicuous area visible to clients @. There isa policy | Document Review and procedure | » Written policy on management ‘on management review review © Compilation of documented minutes of meeting reflectng the date, time, attendance, agenda, and action taken signed and 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. el) ‘OOH-HFSRE-GOFDI-GLG-AT Revs 0 if 2001 Papezor tsCRITERIA INDICATOR/EVIDENCE COMPLIED 5. There is policy and procedure for handling complaints and Glient feedback Document Review ‘+ Written policy and procedure for handling complaints/client feedback ‘+ Suggestion box visible to clients, + Forms for complaints/ client feedback Records of complaints/ client feedback and actions taken ll, HUMAN RESOURCE MANAGEMENT A. STAFF RECRUITMENT, SELECTION, APPOINTMENT AND RESPONSIBILITIES 6. There is policy and procedure Document Review ‘+ Written policies and for hiring, 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 program for staff development and training development and training ‘* Proof of training through relevant certificates, memos, written reports, budgetary allocations Interview © Human Resources Management Officer! Personnel Officer 8, There is policy and procedure for discipline, ‘suspension, demotion and termination of personnel at all levels Document Review ‘* Written policies and procedures ‘on discipline, suspension, demotion and termination of personnel at al levels B, PERSONNEL 9, The duties and responsibilities shall be clearly Document Review ‘* Written job description or duties 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 (DOW-HFSRE-GOFDT-CLGAT Revise OD toe Page Sot 13CRITERIA INDICATOR/EVIDENCE | COMPLIED training and experience to conduct/perform the laboratory procedures: signed and approved by head of laboratory ‘* There is a policy whenever there is an increase in workioad, 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 personnel) + Authority to practice signed by the head of the government facility, applicable (AO. # 92 s. 2003) 17. There is policy on the Document Review ‘© Proof of submission of data to implementation NDHRHIS of National Database of Human Resource for Health Information System (NDHRIS) 12. Each personnel | Document Review shall have a * Updated 201 files of all 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 physica have the overall supervision on technical procedures as well as on the administrative laboratory management visit OR once a month physical visit with at least twice a week of supervisory calls and/or video conferencing * For HOL of hospital-based clinical laboratory: supervisory physical visits of at least once a week + Proof of qualifications: + Updated resume + PRC certificate and valid PRC ID + PSP Board Certificate + Certificate of Good Standing fromPSP_ + Notarized employment contract (DOHFSRS-GOFDI-CLGAT otra Page dol 13CRITERIA INDICATOR/EVIDENCE ‘COMPLIED + Relevant training certificates (e.g., Molecular Pathology) + Annual medical certificate and proof of immunization (Hepatitis B and Influenza) Qualification of Head of Laboratory | Certified CP. » Certified AP. Remarks ‘A. Clinical Laboratory 4. Primary z 2._ Secondary 7 3._Tertiary 7 4._Limited™ ereaac ase B._ Anatomic Laboratory 1 C. Molecular Laborator 1._Genetios eae 2._Immunohematology 1 3._Infectious 1 “Tt will depend on the limited services to be provided “*A pathologist ora 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 assigned area) + Annual medical certificate + Proof of immunization (Hepatitis B and Influenza) CRITERIA INDICATOR/EVIDENCE ‘COMPLIED REMARKS B. Registered | Document Review Medical ‘+ Proof of qualifications: Technologist + Updated resume (RMT) + PRC certificate and valid PRC ID (Atleast 1 + Relevant training certificates competent + Notarized employment RMT per contract RMT staff with designated i Sssignments, as__| Additional proof of trainings applicable: a * Certificate of proficiency (SACCL) 2. AFB microscopy) + Certificate of training on DSSM (NTRL) 3. Bacteriology * Certificate of training in bacteriology (RITM and other RITM recognized institutions) 4, Malaria smear * Certificate of training in malaria smear (RITM) ‘DOH HFSRE-OORD-CLG-AT Revision 00 opty 2 Page Sot 135. Others C. Biosafety and Biosecurity Officer (May be designated by the HOL) Document Review ‘+ PRC certificate and valid PRC 1D (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 eo pee Tm) ae ae) oe ae suit_| sum | shin | sun | snin | shin | snin | shin_| shit Microscopy 1 1 1 1 1 1 1 1 Hematology 1 1 1 1 1 1 1 1 1 Clinical Chemistry 1 1 1 T 1 1 1 immunology/Serology 1 1 1 Microbiology 1 7 Histopathology 1 8 on fofeven without 2 (F i Televe) cron without Hist ct 9 (6+1 reliever) for 12(11+1rolover) | ME TIDe7rohever for Goverment Facilties Hospital-Based_ Note: An increase in worklos ‘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 CRITERIA til, PHYSICAL PLA! INDICATOR/ EVIDENCE NT, FACILITIES, AND WORK ENVIRONMENT REMARKS 13. There is program of proper maintenance and monitoring of physical plant and facilities Document Review ‘* Written policy and program for the proper maintenance and monitoring of physical plant and facilities + Proposed schedule for preventive maintenance Observe ‘Updated proof of actual implementation of maintenance as to structure, ventilation, lighting & water supply 14. There are policy Document Review guidelines on | « Local risk assessment reviewed laboratory at least annually biosafety and | «Written protocols on laboratory biosecurity biosafety and biosecurity Observe * Good Laboratory Practice that includes use of Personal ‘DOH HFSRB.GOFDI-.G-AT Revi 0D 06. $1201 Page or 13CRITERIA INDICATOR / EVIDENCE compuo | REMARKS Protective Equipment and other precautionary measures 15. There isa policy | Document Review and procedure | + Policy on disposal of wastes. for the proper that conform with Healthcare disposal of Waste Management Manual, waste and and RA No. 6969 hazardous/infect | Notarized Memorandum of ious 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) EQUIPMENT /INSTRUMENTS 16. There isan Document 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 17. There is Document Review program for + Regular schedule including calibration, frequency of |_ preventive preventive maintenance and calibration ‘maintenance + Updated certificate of calibraton and repair for and maintenance of equipment the equipment. | « Record of repair reports 78. Thereis| 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 Jreagents with expiration date, stored and their usage! consumption and inventoried disposal are available reagentsand |» Certificate of | Product supplies for the Registration from _FDA. wey DOnHFGRe- COROT LeAT Merge te thee Page ofaCRITERIA INDICATOR / EVIDENCE COMPLIED REMARKS laboratory including the reagents, supplies, ‘examinations to and equipment used for POCT be provided. and MCL Observe * Availability and completeness of reagents and supplies * Validate the expiration dates of reagents 20. The reagents | Document Review and supplies are stored under the «Records of temperature ‘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| Feagents and to 8°C) and freezers (-20°C to - supplies 30°C) 27. There is an Document Review appropriate * Material Safety Data Sheet storage (MSDS) available for all arealtechnique reagents/supplies and for flammable, accessible to all personnel at all combustible and | times hazardous chemical/reagen | 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 Document Review administrative | + All documented _ policies, policies & protocols, procedures are procedures for signed and approved by the provision of head of laboratory laboratory ‘+ Guidelines in the operation and services andfor | maintenance of the laboratory the operation including policy on security of and supplies, specimens and maintenance of confidentiality of records the laboratory | » Laboratory services. and corresponding prices are accessible to the public 23. The technical | Document Review procedures of | « Documented and updated services policies and procedures of provided by laboratory services in each of the sections/areas. Revision 00 Otto Page Bot 13 HH aaCRITERIA INDICATOR/ EVIDENCE eourues __ REMARKS each section are | » Documented policies, protocos, available and guidelines in the operation and maintenance of the laboratory ‘A. Communication and Records 24. There are Document Review procedures forthe| » Documented procedures for receipt and receipt and performance of performance of laboratory tests, laboratory tests 25. There are Document Review procedures for | * 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 original/digita examinations of signature with PRC ID No. of the ‘specimens: head of the laboratory and the A. shall bearthe | RMT analysts . name of the | © Updated records of result pathologist or | —_(logbooks/ electronically stored designated data with back up) including associate entry, releasing & endorsement who shall be records. responsible |» There is a policy guideline on forthe the use of authenticated reliability 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 that/those person(s) 27. There are Document review procedures for | * Documented procedures for reporting of reporting of workload, quality workload, quality control, inventory control, etc. control, * Updated reports and documents inventory (hard or soft copy with back up) control, etc. * Worksheets/machine print out per section as proof of actual performance DOHHFSRG-OOFOTGLG-AT erent Paar28. There is a Document review | procedure for * 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 isa | 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 (OC# 705.1996) | and/or | ‘competent | professional =| ‘organizations | B. Quality Assurance 30. There is a policy | Document review on Quality * Documented Interal QAP Assurance including Internal Quality Program (QAP) Control and Continuous Quality and Continuous Improvement Quality ‘© Updated Quality Control reports Improvement | conducted per tests and filed accordingly | + Availability of /—_reference | materials and appropriate | teagents & equipment used + Resuitsfindings of Quality Assurance audits / assessments There is a proof | Document review of participation in| * Documented procedure in the ExtemalQAP actual. performance of EQAP {EQAP) that may | activities be administered | « Certificate of Performance in by a designated EQAP with passing rate NRL or other local and international EQAP approved by the DOH C. Referral or Outsourcing of Laboratory Tests even 00 nen ape tot 13CRITERIA INDICATOR/ EVIDENCE COMPLIED REMARKS: 32. There is a policy on referral and ‘outsourcing of examinations Document Review * Documented procedures on referral and outsourcing of examinations to other DOH licensed clinical iaboratory * Records of |-—_outsourced examinations (in the event of machine breakdown) * Notarized Memorandum of ‘Agreement * DOH-LTO of referral testing laboratory VI POINT OF CARE TESTING (POCT) 33. There is a policy on POCT Document Review * Documented list of POCT operators, ‘machines, 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. Vill, MOBILE CLINICAL LABORATORY 34, There is a policy ‘on Mobile Clinical Laboratory Document Review ‘+ Documented Procedures on + Collection of specimens + Processing of specimens ‘* Land Transportation Office Registration (proof of ownership) + File of Memorandum of ‘Agreement between the clinical laboratory and the facility where the mobile activity is conducted DONHFSRS.GORI-CLGAT Page Hof 13Republic of the Philippines Department of Health HEALTH FACILITIES AND SERVICES REGULATORY BUREAU Name of Facility Date of inspection: RECOMMENDATIONS: For Licensing Process tl For Issuance of License to Operate as: Validity from to issuance depends upon compliance to the recommendations given and submission of the a following within days fromthe dale of inspection. tl Non-issuance. Specify reasons: | Inspected by: PentedName Senature PostionDesignaon Received by: Printed Nam Position/Designation: ~ 4 ‘DOH HFERS.GORDT-CLG-AT % Page 120113Republic of the Philippines Department of Heaith HEALTH FACILITIES AND SERVICES REGULATORY BUREAU Name of Facility Date of Monitoring RECOMMENDATIONS: For Monitoring Process 1 Issuance of Notice of Violation. tl Nom-issuance of Notice of Violation. t1 Others. Specty: Monitored by: _ Senate Postion/Designation Received by: Signature: Printed Name: Position/Designation: Date: yy ‘DOHHFSR.GOFDT-LG-AT % Pope ido 13