📄 NQAS Assessor's Guide for Integrated Public Health Laboratory (IPHL) Version Number: Name of the Laboratory Date of Assessment

NQAS Assessor's Guide for Integrated Public Health Laboratory (IPHL) Version Number: NQAS/IPHL-2024/00 Name of the Laboratory Date of Assessment Name of the Assessor Name of Assessee Type of Assessment Internal/State/National Name of State/UT NQAS Scorecard Overall Score of IPHL Area of Concern wise score Service Provision 50% Patient Rights 50% Inputs 50% Support Services 50% Clinical Services 50% Infection Control 50% Quality Management 50% 50% Outcome 50% Major Gaps Observed 1 2 3 4 5 Strengths/Good Practices 1 2 3 4 5 Recommendations/Opportunities for improvement 1 2 3 4 5 Assessor's Guide for IPHL Reference No. Area of Concern and Standards Score in % Area of Concern - A Service Provision StandardA1 FacilityProvides IntegratedDiagnosticLaboratory Servicesas per mandate 50% StandardA2 Facilityprovide support servicesto linked spokes 50% Area of Concern - B Patient Rights StandardB1 The serviceprovided at facilityare accessibleand affordable 50% StandardB2 The serviceprovided at facilityare acceptable 50% StandardB3 The facilityhas defined framework for ethicalmanagementincludingdilemmasconfronted during delivery of servicesat public health facilities. 50% Area of Concern - C Inputs StandardC1 The facilityhas infrastructurefor deliveryof assured services,and availableinfrastructuremeets the prevalent norms 50% StandardC 2 The facilityensures the physical safety of the infrastructure. 50% StandardC3 The facilityhas establishedProgrammefor fire safety and other disaster 50% StandardC4 The facilityhas adequatequalifiedand trainedstaff, requiredfor providing the assured servicesto the current case load 50% StandardC 5 Facilityensures reagentsand consumablesrequiredfor assured list of services 50% StandardC 6 The facilityhas equipment& instruments requiredfor assured list of services. 50% StandardC7 Facilityhas a defined and establishedprocedurefor effectiveutilization,evaluationand augmentation of competenceand performanceof staff 50% -- 1 of 31 -- Area of Concern - D Support Services StandardD1 The facilityhas establishedProgrammefor inspection,testing and maintenanceand calibrationof Lab 50% StandardD2 The facilityhas defined proceduresfor storage, inventory managementand dispensing of consumables and reagents 50% StandardD3 The facilityprovides safe, secureand comfortableenvironmentto staff, patients and visitors. 50% StandardD4 The facilityhas establishedProgrammefor maintenanceand upkeep of the facility 50% StandardD5 The facilityensures 24X7 water and power backup as per requirementof servicedelivery,and support servicesnorms 50% StandardD6 The facilityensures support to all linked labs as per servicemandate 50% StandardD7 Facilityhas defined and establishedproceduresfor FinancialManagement 50% StandardD8 Facilityis compliantwith all statutory and regulatoryrequirementimposed by local, state or central 50% StandardD9 Roles & Responsibilitiesof administrativeand clinicalstaff are determinedas per govt. regulationsand standards operatingprocedures. 50% StandardD10 Facilityhas establishedprocedurefor monitoring the quality of outsourced servicesand adheresto contractualobligations 50% Area of Concern - E Clinical Services StandardE1 The laboratoryhas defined proceduresfor registrationof Patients at the laboratory 50% StandardE2 Facilityhas establishedmechanismfor referrallinkagesto maintaincontinuity of services 50% StandardE3 The facilityhas establishedand defined procedurefor pre-testingactivities 50% StandardE4 The facilityhas establishedand defined procedurefor testing activities 50% StandardE5 Laboratory has defined and establishedprocedurefor the post testing processes 50% StandardE6 The facilityhas establishedmechanismfor internaland externalvalidationof testing procedures 50% StandardE7 Facilityhas defined and establishedproceduresfor maintaining,updating of patients’ clinicalrecords and their storage 50% StandardE8 The facilityhas defined and establishedproceduresfor EmergencyServicesand DisasterManagement 50% StandardE9 Facilityprovides National health program as per operational/ClinicalGuidelines 50% Area of Concern - F Infection Control StandardF1 Facilityhas infectionpreventioncontrol program and proceduresin place 50% StandardF2 Facilityhas defined and Implementedproceduresfor ensuring hand hygienepracticesand antisepsis 50% StandardF3 Facilityensures standard practicesand materialsfor Personal protection 50% StandardF4 Facilityhas standard Proceduresfor processingof equipmentsand instruments 50% StandardF5 Physical layout and environmentalcontrol of the laboratoryensures infectionprevention 50% StandardF6 Facilityhas defined and establishedproceduresfor segregation,collection,treatmentand disposal of Bio Medicaland hazardous Waste. 50% Area of Concern - G Quality Management StandardG1 The facilityhas defined mission, vision, values, quality policy and objectives, and preparesa strategic plan to achievethem 50% StandardG2 The facilityhas establishedorganizationalframework for quality improvement 50% StandardG3 The facilityhas documented, implementedand updated Standard OperatingProceduresfor all key processes and support services 50% StandardG4 The facilityhas establishedinternal& externalquality assuranceprogrammesfor laboratoryfunctions 50% StandardG 5 The facilityseeks continualimprovementby practisingQuality method and tools 50% StandardG6 The facilitymaps its key processesand seeks to make them more efficientby reducingnon value adding activitiesand wastages 50% StandardG7 The facilityhas defined, approved and communicatedRisk Managementframework for existing and 50% StandardG8 The facilityhas establishedproceduresfor assessing, reporting,evaluatingand managing risk as per Risk ManagementPlan 50% StandardsG9 The facilityhas establishedsystem for patient and employeesatisfaction 50% Area of Concern - H Outcome StandardH1 The facilitymeasuresProductivity Indicators and ensures compliancewith State/Nationalbenchmarks 50% StandardH2 The facilitymeasuresEfficiencyIndicators and ensure compliancewith State/Nationalbenchmarks 50% StandardH3 The facilitymeasuresClinicalCare & Safety Indicators and ensure compliancewith State/National 50% StandardH4 The facilitymeasuresServiceQuality Indicators and ensure compliancewith State/Nationalbenchmarks 50% -- 2 of 31 -- National Quality Assurance Standards Version Number: NQAS/IPHL-2024/00 Assessor's Guide for Integrated Public Health Laboratory (IPHL) Reference No. Measurable Element Checkpoint Compliance Assessment Method Means of Verification Remarks Area of Concern - A Service Provision Standard A1 Facility provides Integrated Diagnostic Laboratory Services as per mandate ME A1.1 Facility provides comprehensive set of Laboratory services Availability of Haematology services 1 SI/RR Hb%, TC, DC, Platelet, CBC, ESR, BG & Rh typing, Blood cross matching, Peripheral blood film, Reticulocyte count, AEC, Fibrinogen degradation products, D-Dimer, Coobs test direct & indirect with titre, Sickling test for screening of sickle cell anaemia, rapid sickle cell test, DCIP test for screening HbE hemoglobinopathy, G6PD enzyme deficiency, Prothrombin time (PT) & International Normalised Ratio (INR), Activated partial thromboplastin time, Mixing study for Factor Deficiency & inhibitors Haemophilia, Haemoglobin electrophoresis, HPLC, Serum Electrophoresis & free light chain assay, Availability of Biochemistry services 1 SI/RR GTT, S.Bilirubin (Total, Direct & Indirect), S.Creatinine, Blood urea, SGOT, SGPT, S.Alkaline Phosphatase, S.Total protein, S.Albumin & AG ratio, S.Globulin, S.Total cholesterol, S.Triglycerides, VLDL, HDL, LDL, GGT, Uric acid, S.Amylase, S.Iron, S.Total Iron binding capacity, S.LDH, HbA1C, CRP, S.Electrolytes, S.Ionised Calcium, Atrterial blood gas test, Urinary protein, Urine for microalbumin, creatinine & protein, Thyroid profile, Ferritin, Troponin-I/ Troponin-T, S.PSA, CSF & body fluid analysis Availability of Microbiology services 1 SI/RR Wet mount & gram stain for RTI/STD, KOH mount for fungal microscopy, Slit skin smear, Gram staining for clinical specimen, Throat swab for Diphtheria, Stool hanging drop for Vibrio Cholera, Blood/body fluid culture, Urine/other cultures, Diphtheria culture, Culture of stool, Bacterial identification & AST Availability of Cytology services 1 SI/RR FNAC, Pap smear, CSF & body fluid counts cytology Availability of Histopathology services 1 SI/RR Histopathology, Tissue biopsy Availability of Clinical Pathology services 1 SI/RR UPT, Urine test for pH, specific gravity, leucocyte esterase, glucose, bilirubin, urobilinogen, ketone, protein, nitrite, Urine microscopy, Stool for ova, cyst & occult blood, Semen analysis Availability of Serology services 1 SI/RR RPR/VDRL, HIV 1 & 2, Widal, Leptospirosis, Typhus, Measles, Leishmaniasis, Bacterial meningitis, PCR for influenza, COVID-19 & emerging infectious diseases Availability of Water culture test services 1 SI/RR Culture for coliforms & RDTs to support outbreak investigation, Mic