Verified Service Provider in Nigeria
Molecular Diagnostics Labs in Nigeria
Engineering Excellence & Technical Support
Molecular Diagnostics Labs solutions for Clinical & Diagnostic Labs. High-standard technical execution following OEM protocols and local regulatory frameworks.
Advanced PCR and Sequencing Capabilities
Leveraging state-of-the-art Polymerase Chain Reaction (PCR) and next-generation sequencing (NGS) technologies, our labs provide highly accurate and sensitive molecular diagnostics for infectious diseases, genetic disorders, and personalized medicine. We offer rapid turnaround times for critical diagnoses.
Rapid Pathogen Identification & Antimicrobial Resistance (AMR) Profiling
Our molecular platforms enable swift and precise identification of bacterial, viral, and parasitic pathogens directly from patient samples. Crucially, we offer integrated AMR profiling, guiding clinicians towards effective treatment regimens and combating the growing threat of antibiotic resistance in Nigeria.
AI-Powered Data Analytics for Public Health Insights
We integrate advanced bioinformatics and AI-driven data analytics into our molecular diagnostic workflows. This allows for the real-time tracking of disease outbreaks, identification of emerging pathogens, and provides invaluable insights for public health surveillance and policy-making across Nigeria.
What Is Molecular Diagnostics Labs In Nigeria?
Molecular diagnostics laboratories in Nigeria represent a critical and rapidly evolving segment of the healthcare infrastructure, focused on the identification and characterization of diseases through the analysis of biological molecules. These laboratories employ sophisticated techniques to detect genetic material (DNA and RNA), proteins, and other biomolecules present in patient samples. This allows for highly specific and sensitive detection of pathogens, identification of genetic predispositions to diseases, and monitoring of treatment efficacy. The services offered are indispensable for modern medical practice, moving beyond symptomatic diagnosis to a precise, molecular-level understanding of health and disease.
| Who Needs Molecular Diagnostics Services? | Typical Use Cases |
|---|---|
| Infectious Disease Control Programs: Public health agencies, hospitals, and clinics involved in managing outbreaks and endemic infectious diseases. | Diagnosis and management of infectious diseases: Rapid and accurate identification of viral (e.g., HIV, HBV, HCV, COVID-19, Ebola), bacterial (e.g., TB, typhoid), parasitic (e.g., malaria), and fungal pathogens. Antimicrobial resistance (AMR) testing. |
| Oncology Centers and Hospitals: Cancer treatment facilities and departments focused on personalized medicine and cancer screening. | Cancer diagnosis and management: Detection of cancer-specific mutations for targeted therapies, liquid biopsies for monitoring treatment response and recurrence, oncogenic virus detection (e.g., HPV, EBV). |
| Maternity and Reproductive Health Clinics: Obstetricians, gynecologists, and fertility clinics. | Prenatal screening and diagnosis: Detection of chromosomal abnormalities (e.g., Down syndrome), genetic disorders, and infections in pregnant women and fetuses. Carrier screening for genetic diseases. |
| Gastroenterology and Hepatology Departments: Specialists managing liver diseases and gastrointestinal disorders. | Hepatitis diagnosis and monitoring: Genotyping of Hepatitis B and C viruses, viral load quantification for treatment monitoring. |
| Neurology and Genetic Counseling Services: Neurologists and genetic counselors evaluating patients with suspected inherited neurological disorders. | Diagnosis of genetic disorders: Identification of mutations associated with inherited neurological diseases (e.g., Huntington's disease, muscular dystrophies), genetic predisposition testing. |
| Research Institutions and Universities: Academic and research bodies conducting biomedical research. | Biomedical research: Gene expression studies, population genetics, drug discovery and development, vaccine research. |
| Forensic Science Laboratories: Law enforcement agencies and forensic investigators. | Forensic identification: DNA profiling for criminal investigations, paternity testing, identification of unknown individuals. |
| General Practitioners and Primary Care Physicians: To facilitate early and precise diagnosis for referral or direct management. | Early diagnosis and risk assessment: Identifying specific conditions that require targeted intervention, thereby improving patient outcomes and reducing healthcare costs. |
Key Components of Molecular Diagnostics in Nigeria
- {"title":"Technological Platforms","description":"Utilization of advanced instrumentation for nucleic acid extraction, amplification (e.g., PCR, qPCR, isothermal amplification), sequencing (e.g., Sanger, Next-Generation Sequencing - NGS), and hybridization techniques (e.g., microarrays, FISH)."}
- {"title":"Assay Development and Validation","description":"Design, optimization, and validation of molecular assays for specific diagnostic targets, ensuring accuracy, sensitivity, and specificity according to international standards and local epidemiological data."}
- {"title":"Sample Processing and Analysis","description":"Collection, handling, storage, and processing of various biological samples (blood, urine, tissue biopsies, swabs, saliva) followed by quantitative or qualitative molecular analysis."}
- {"title":"Data Interpretation and Reporting","description":"Expert interpretation of complex molecular data by trained molecular biologists and bioinformaticians, leading to actionable diagnostic reports for clinicians."}
- {"title":"Quality Assurance and Control","description":"Implementation of rigorous internal and external quality control measures, proficiency testing, and adherence to Good Laboratory Practice (GLP) and ISO 15189 standards to ensure reliable results."}
Who Needs Molecular Diagnostics Labs In Nigeria?
Molecular diagnostics laboratories are crucial for advancing healthcare in Nigeria. They offer precise and rapid identification of diseases, enabling timely and targeted treatment, thereby improving patient outcomes and reducing the burden of infectious and chronic illnesses. Their services are essential for accurate disease screening, monitoring treatment efficacy, and facilitating personalized medicine approaches.
| Customer Type/Department | Key Needs/Applications | Specific Examples |
|---|---|---|
| Hospitals (Public & Private) | Infectious disease diagnosis (bacterial, viral, parasitic), cancer diagnostics, genetic testing, antimicrobial resistance profiling, prenatal screening, pathogen surveillance. | Infectious Disease Units, Oncology Departments, Obstetrics & Gynecology, Pathology Departments, Intensive Care Units (ICUs). |
| Research Institutions & Universities | Disease mechanism studies, drug discovery, epidemiological research, genetic research, development of new diagnostic assays. | Pathology & Microbiology Departments, Genetics Departments, Medical Research Institutes, Faculties of Medicine and Health Sciences. |
| Public Health Agencies | Epidemic surveillance, outbreak investigation, disease control programs, vaccine efficacy monitoring, food and water safety testing. | National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria Centre for Disease Control (NCDC), State Ministries of Health, Public Health Laboratories. |
| Clinical Laboratories | Complementary diagnostic services, advanced testing capabilities, referral services for complex cases, quality assurance. | Independent Diagnostic Laboratories, Hospital-based Clinical Laboratories. |
| Pharmaceutical & Biotechnology Companies | Clinical trial support, drug development, companion diagnostics, quality control of biological products. | R&D Departments, Clinical Research Organizations (CROs). |
| NGOs in Health Sector | Targeted disease intervention programs (e.g., HIV/AIDS, malaria, TB), community health screening, health advocacy. | Organizations focusing on specific diseases, maternal and child health NGOs, global health initiatives. |
| Individual Clinicians & Diagnostic Centers | Accurate and rapid diagnosis for patient management, specialized testing for complex cases, personalized treatment recommendations. | Private Clinics, General Practitioners, Specialists (e.g., Oncologists, Hematologists, Infectious Disease Specialists). |
Target Customers and Departments for Molecular Diagnostics Labs in Nigeria
- Hospitals (Public and Private)
- Research Institutions and Universities
- Public Health Agencies
- Clinical Laboratories
- Pharmaceutical and Biotechnology Companies
- Non-Governmental Organizations (NGOs) in Health Sector
- Individual Clinicians and Diagnostic Centers
Molecular Diagnostics Labs Process In Nigeria
Molecular diagnostics labs in Nigeria play a crucial role in identifying diseases at the molecular level, enabling precise diagnosis, prognosis, and treatment selection. The workflow typically begins with an initial inquiry or a doctor's request, followed by sample collection, transportation, laboratory testing, data analysis, and finally, reporting. This structured process ensures accuracy, efficiency, and patient safety.
| Stage | Key Activities | Responsible Personnel | Critical Considerations |
|---|---|---|---|
| Inquiry/Requisition | Doctor's request for molecular testing, specifying suspected condition. | Referring Physician/Healthcare Provider | Accurate and complete clinical information, appropriate test selection. |
| Registration & Information Gathering | Patient data entry, clinical history documentation. | Lab Administrator/Receptionist | Confidentiality of patient information, accurate data entry. |
| Sample Collection | Collection of blood, swabs, bodily fluids, etc., as per protocol. | Phlebotomist/Nurse/Trained Technician | Correct sample type, sterile technique, proper labeling, patient comfort. |
| Sample Transportation & Handling | Secure packaging, maintaining cold chain (if required), timely delivery. | Courier/Laboratory Staff | Sample integrity, preventing contamination, adherence to biohazard guidelines. |
| Sample Reception & Quality Control | Logging samples, initial visual inspection, checking labels and integrity. | Laboratory Receptionist/Technician | Accurate logging, prompt identification of issues, rejection of unsuitable samples. |
| Sample Preparation/Extraction | Nucleic acid (DNA/RNA) isolation from sample. | Laboratory Technologist/Scientist | Use of validated kits/protocols, avoiding contamination, maximizing yield. |
| Molecular Assay (Testing) | Performing PCR, RT-PCR, NGS, etc., based on the test requested. | Laboratory Technologist/Scientist | Adherence to Standard Operating Procedures (SOPs), proper instrument calibration, running controls. |
| Data Analysis & Interpretation | Analyzing raw data, identifying positive/negative results, quantification. | Laboratory Technologist/Scientist/Bioinformatician | Accurate interpretation, comparison with reference standards, understanding assay limitations. |
| Quality Assurance & Validation | Reviewing QC data, validating results, ensuring accuracy and reliability. | Senior Technologist/Pathologist/Lab Manager | Independent verification, adherence to accreditation standards. |
| Report Generation & Delivery | Compiling and issuing the final report to the referring physician. | Laboratory Administrator/Pathologist | Clarity of reporting, timely delivery, secure transmission. |
Molecular Diagnostics Lab Process in Nigeria: Workflow from Inquiry to Execution
- Inquiry/Requisition: The process starts with a doctor or healthcare provider identifying a need for molecular diagnostic testing for a patient. This can be driven by suspicion of a specific infection (e.g., COVID-19, HIV, malaria), genetic disorder, or cancer.
- Patient Registration & Information Gathering: Upon receiving the request, the lab registers the patient. This involves collecting demographic details, clinical history, reason for testing, and referring physician's information.
- Sample Collection: Trained personnel collect the appropriate biological sample. The type of sample depends on the suspected condition and can include blood, urine, saliva, sputum, cerebrospinal fluid, tissue biopsies, or swabs.
- Sample Transportation & Handling: Samples are transported to the laboratory under specific conditions to maintain their integrity. This may involve maintaining a cold chain (refrigeration or freezing), using appropriate collection tubes (e.g., EDTA tubes for DNA), and proper labeling to prevent mix-ups.
- Sample Reception & Quality Control: Upon arrival, samples are logged into the laboratory information management system (LIMS). Initial quality checks are performed to ensure the sample is viable, properly labeled, and has sufficient volume. Any issues are documented, and the sample may be rejected.
- Sample Preparation/Extraction: Nucleic acids (DNA or RNA) are extracted from the collected sample. This is a critical step that removes inhibitors and isolates the genetic material for subsequent analysis. Various kits and protocols are used for this purpose.
- Molecular Assay (Testing): The extracted nucleic acids are subjected to specific molecular tests. Common techniques include:
- Polymerase Chain Reaction (PCR) and Real-Time PCR (RT-PCR): Used to amplify specific DNA or RNA sequences, detecting the presence or absence of pathogens or genetic mutations.
- Next-Generation Sequencing (NGS): Used for comprehensive genomic analysis, identifying multiple genetic variations or pathogens simultaneously.
- Genotyping: Used to determine specific genetic markers or variations.
- Viral Load Quantification: Measures the amount of viral genetic material in a sample, important for monitoring treatment efficacy (e.g., HIV, Hepatitis).
- Data Analysis & Interpretation: Raw data from the molecular assays are analyzed using specialized software. This involves identifying positive and negative results, quantifying levels (e.g., viral load), and comparing findings against established reference ranges or databases.
- Quality Assurance & Validation: Throughout the process, quality control measures are implemented. This includes using positive and negative controls with each batch of tests to ensure the assay is functioning correctly.
- Report Generation: A comprehensive report is generated detailing the findings, including the specific test performed, the results obtained, their interpretation, and any relevant clinical correlations. This report is often reviewed and validated by a pathologist or senior technologist.
- Result Delivery: The final report is securely delivered to the referring physician and, in some cases, to the patient directly, often electronically or via a secure portal. Follow-up consultation may be offered to discuss the results and implications.
Molecular Diagnostics Labs Cost In Nigeria
Molecular diagnostics labs in Nigeria offer a range of services, crucial for accurate disease detection and management. The cost of these tests is influenced by several factors, including the specific test required, the technology employed, the location of the laboratory, and the associated consumables and reagents. The prices can vary significantly across different providers and geographic regions within Nigeria. Generally, more complex tests requiring advanced equipment and specialized reagents tend to be more expensive. Overhead costs for the laboratories, such as rent, staff salaries (highly skilled personnel are needed), and maintenance of sophisticated equipment, also contribute to the overall pricing structure. Furthermore, import duties and the fluctuating exchange rate of the Naira against major international currencies can impact the cost of imported diagnostic kits and reagents, thus influencing the final price of the molecular diagnostic tests.
| Diagnostic Test Category | Estimated Price Range (NGN) | Notes |
|---|---|---|
| Viral Load Testing (e.g., HIV, Hepatitis B & C) | 15,000 - 40,000 | Prices can vary based on the specific virus and platform used. |
| Pathogen Identification (e.g., Bacteria, Fungi) | 10,000 - 35,000 | Depends on the suspected pathogen and the breadth of the test panel. |
| Genetic Testing (e.g., Pharmacogenomics, Carrier Screening) | 30,000 - 100,000+ | Often involves more complex sequencing and analysis, with significant price variation. |
| COVID-19 PCR Testing | 15,000 - 30,000 | Prices have generally decreased with increased availability and competition, but can still vary. |
| HPV Genotyping | 12,000 - 25,000 | Specific to identifying high-risk and low-risk Human Papillomavirus types. |
| Tuberculosis (TB) GeneXpert | 18,000 - 35,000 | Detects TB and rifampicin resistance. Price influenced by cartridge cost. |
| Malaria Parasite Detection (Molecular) | 8,000 - 18,000 | More sensitive than microscopy for certain parasite types and identification. |
Factors Influencing Molecular Diagnostics Lab Costs in Nigeria
- Type of Test: Different molecular diagnostic tests have varying complexities and require different reagents and protocols.
- Technology Used: Advanced technologies like PCR (Polymerase Chain Reaction), sequencing, and real-time PCR often involve higher equipment and operational costs.
- Laboratory Location: Major cities and more developed regions might have higher operational costs, potentially reflecting in test prices.
- Consumables and Reagents: The cost of specialized kits, enzymes, primers, and other consumables is a significant driver.
- Import Costs & Exchange Rates: Fluctuations in currency exchange rates and import duties on diagnostic materials directly affect pricing.
- Overhead Expenses: Rent, utilities, skilled personnel salaries, and equipment maintenance contribute to the overall cost.
- Volume and Throughput: Larger labs with higher testing volumes might achieve economies of scale, potentially leading to slightly lower per-test costs.
Affordable Molecular Diagnostics Labs Options
Finding affordable molecular diagnostics labs is crucial for accessible healthcare. This involves understanding the pricing structures, exploring available discounts, and leveraging value-added services. Molecular diagnostics, while powerful, can be expensive. Therefore, identifying cost-effective options without compromising on quality is paramount for patients, healthcare providers, and research institutions. This guide will delve into strategies and options to achieve this, focusing on value bundles and cost-saving measures.
| Value Bundle Type | Description | Potential Cost Savings | Considerations |
|---|---|---|---|
| Comprehensive Genetic Panels | Bundles multiple genes or mutations related to a specific condition (e.g., hereditary cancer, cardiovascular risk, infectious disease panels). | Lower per-gene cost compared to individual gene testing; efficient for broad screening. | Ensure the panel covers the specific genes of interest; may include unnecessary tests for some patients. |
| Infectious Disease Panels | Combines testing for multiple common or co-infecting pathogens (e.g., respiratory panels, gastrointestinal panels, STI panels). | Faster diagnosis with a single sample; reduced lab processing time and cost per pathogen. | Accuracy for less common pathogens might be lower in broad panels; consider specific needs. |
| Therapeutic Drug Monitoring (TDM) Bundles | Packages for monitoring multiple drugs with similar therapeutic windows or patient populations. | Streamlined workflow for clinicians; potential for volume discounts from the lab. | Requires careful selection of drugs to bundle; patient adherence is key for accurate TDM. |
| Oncology Marker Bundles | Groups of molecular markers frequently tested together for cancer diagnosis, prognosis, or treatment selection. | Efficient profiling of cancer mutations; aids in personalized medicine approaches. | Ensure the bundle aligns with current treatment guidelines and the specific cancer type. |
| Screening Panels | Broad panels designed for initial screening of common genetic predispositions or health risks. | Cost-effective for large-scale population screening or initial risk assessment. | May require follow-up confirmatory testing for positive results; potential for overdiagnosis or unnecessary anxiety. |
Key Strategies for Affordable Molecular Diagnostics Labs
- Understanding Pricing Models: Different labs have varied pricing. Some offer per-test pricing, while others have tiered pricing based on volume or complexity.
- Negotiating Rates: For larger institutions or regular clients, negotiating bulk discounts or contracted rates is often possible.
- Exploring Value Bundles: Labs may offer packages of common tests or panels that are more cost-effective than individual testing.
- Leveraging Insurance and Reimbursement: Understanding your insurance coverage for molecular diagnostics is essential. Labs can often assist with pre-authorization and billing.
- Considering Referral and Outsource Options: For highly specialized or rare tests, it might be more cost-effective to use a referral lab with expertise and established pricing for that specific assay.
- In-house vs. Outsourced Decisions: For some healthcare facilities, evaluating the cost-effectiveness of setting up an in-house lab versus outsourcing specific tests is a critical financial decision.
- Comparing Turnaround Times and Quality: While cost is a factor, ensure that the affordable option still meets your required turnaround times and maintains a high standard of accuracy and reliability.
- Utilizing Technology and Automation: Labs that invest in efficient, automated workflows can often pass on cost savings to their clients.
- Seeking Transparent Fee Structures: Opt for labs that clearly outline their pricing, including any potential additional fees for consumables, shipping, or reporting.
Verified Providers In Nigeria
In Nigeria's rapidly growing healthcare landscape, identifying trustworthy and competent medical practitioners is paramount. 'Verified Providers' signifies a crucial layer of assurance for patients, indicating that these healthcare professionals have undergone rigorous credentialing and adhere to established standards of care. Franance Health stands out as a leading organization dedicated to this verification process. Their meticulous approach to credentialing ensures that the providers they endorse meet the highest benchmarks for medical expertise, ethical practice, and patient safety. This dedication to quality makes Franance Health-verified providers the superior choice for individuals seeking reliable and exceptional healthcare in Nigeria.
| Provider Type | Franance Health Verification Benefits | Why They Are the Best Choice |
|---|---|---|
| Specialist Doctors | Guaranteed expertise in their field, up-to-date knowledge, and proven track record. | Access to top-tier specialists for complex medical conditions, ensuring accurate diagnoses and effective treatment plans. |
| General Practitioners | Thorough vetting of general medical knowledge, diagnostic skills, and patient management capabilities. | Reliable primary care physicians who can address a wide range of health concerns with competence and a patient-centered approach. |
| Nurses and Allied Health Professionals | Verification of qualifications, practical skills, and commitment to compassionate care. | Skilled and dedicated nursing staff and allied professionals who support patient recovery and well-being across various healthcare settings. |
| Hospitals and Clinics | Ensures that facilities meet stringent standards for infrastructure, equipment, hygiene, and medical protocols. | Safe, well-equipped, and professionally managed healthcare institutions offering a comprehensive range of services with a focus on patient safety and positive outcomes. |
Why Franance Health Credentials Matter:
- Rigorous background checks and verification of medical licenses.
- Assessment of clinical experience and specialized training.
- Confirmation of adherence to ethical medical practices and patient care standards.
- Commitment to ongoing professional development and continuing education.
- Enhanced patient trust and confidence in the quality of care received.
Scope Of Work For Molecular Diagnostics Labs
This document outlines the Scope of Work (SOW) for Molecular Diagnostics Laboratories, focusing on the technical deliverables and standard specifications required for establishing and operating these facilities. It covers the essential components, processes, and quality assurance measures that define a functional and compliant molecular diagnostics laboratory.
| Category | Technical Deliverables | Standard Specifications/Requirements | Notes |
|---|---|---|---|
| Laboratory Design and Infrastructure | Layout plans, biosafety levels (BSL), HVAC systems, waste management systems, cleanroom facilities (if applicable). | Adherence to BSL-2 or BSL-3 standards as per CDC/WHO guidelines. Adequate air changes per hour (ACH), negative pressure for containment areas, HEPA filtration. Segregated areas for pre-amplification and post-amplification. Secure sample storage. | Crucial for preventing contamination and ensuring personnel safety. |
| Equipment and Instrumentation | List of essential equipment (e.g., PCR machines, sequencers, liquid handlers, centrifuges, biosafety cabinets, refrigerators/freezers). | Validated, calibrated, and maintained instruments. Specific throughput requirements based on expected sample volume. Compatibility with chosen assays and workflow. Automated systems for reproducibility. | Investment in high-quality, reliable equipment is paramount. |
| Reagents and Consumables | Procurement strategy for certified and validated reagents, kits, and consumables. | Use of FDA-approved or CE-marked reagents where applicable. Traceability of all reagents. Strict inventory management and expiry date tracking. Bulk purchasing agreements. | Ensures accuracy and reproducibility of test results. |
| Workflow and Process Development | Detailed Standard Operating Procedures (SOPs) for sample reception, processing, nucleic acid extraction, amplification, detection, data analysis, and reporting. | Optimization of each step for efficiency and minimal error. Validation of all assay protocols. Turnaround time (TAT) targets. | Defines the operational backbone of the lab. |
| Quality Management System (QMS) | Implementation of a robust QMS including internal and external quality control (QC) procedures, proficiency testing (PT), corrective and preventive actions (CAPA), documentation control. | Adherence to ISO 15189, CLIA, or CAP guidelines. Regular internal audits. Participation in accredited PT programs. Documented validation of all analytical procedures. | Guarantees the reliability and accuracy of test results. |
| Information Technology (IT) and Data Management | Laboratory Information Management System (LIMS), secure data storage, backup procedures, network infrastructure, cybersecurity measures. | Configurable LIMS for sample tracking, result entry, reporting, and billing. Compliance with HIPAA/GDPR for patient data. Regular data backups and disaster recovery plan. | Essential for efficient operations and data integrity. |
| Personnel and Training | Defined roles and responsibilities, training matrix, competency assessments, continuing education programs. | Qualified personnel (e.g., medical technologists, molecular biologists, lab technicians) with appropriate certifications. Documented training on SOPs, equipment, and safety protocols. Regular competency evaluation. | Skilled personnel are critical for laboratory success. |
| Regulatory Compliance and Accreditation | Understanding and adherence to relevant local, national, and international regulations (e.g., FDA, EMA, CAP, CLIA). Accreditation readiness. | Obtaining necessary licenses and permits. Maintaining compliance with evolving regulatory requirements. Documentation for accreditation surveys. | Ensures legal operation and trustworthiness of the lab. |
Key Components of a Molecular Diagnostics Laboratory SOW
- Laboratory Design and Infrastructure
- Equipment and Instrumentation
- Reagents and Consumables
- Workflow and Process Development
- Quality Management System (QMS)
- Information Technology (IT) and Data Management
- Personnel and Training
- Regulatory Compliance and Accreditation
Service Level Agreement For Molecular Diagnostics Labs
This Service Level Agreement (SLA) outlines the guaranteed response times for critical issues and the minimum uptime for the molecular diagnostics laboratory's IT infrastructure and core testing platforms. The objective is to ensure the reliability and availability of services essential for patient care and research.
| Service/System | Critical Issue Response Time | Critical Issue Resolution Time | Major Issue Response Time | Uptime Guarantee |
|---|---|---|---|---|
| Core Testing Platforms (e.g., PCR, NGS sequencers, automated sample prep) | 15 minutes | 4 hours (or to agreed workaround) | 1 hour | 99.9% |
| Laboratory Information Management System (LIMS) - Core Functions (sample tracking, accessioning, result entry) | 15 minutes | 3 hours (or to agreed workaround) | 1 hour | 99.9% |
| Data Storage & Archiving (critical patient data) | 30 minutes | 8 hours | 4 hours | 99.95% |
| Network Connectivity (internal lab network, access to EMR) | 10 minutes | 2 hours | 1 hour | 99.9% |
| Ancillary Systems (e.g., instrument printers, non-critical workstations) | 1 hour | 24 hours | 4 hours | 99.0% |
Definitions
- Critical Issue: An event that prevents or significantly impairs the operation of a core molecular diagnostic testing platform or the primary LIMS (Laboratory Information Management System), leading to an inability to process patient samples or report critical results.
- Major Issue: An event that degrades the performance of a testing platform or LIMS but does not completely halt operations, or affects a non-critical system.
- Minor Issue: Any issue that does not fall under Critical or Major, including cosmetic problems, minor feature malfunctions, or general performance slowdowns.
- Response Time: The maximum time allowed from the initial reporting of an issue (via designated channels) to the first acknowledgment and commencement of investigation by the IT support team or platform vendor.
- Resolution Time: The maximum time allowed from the initial reporting of an issue to its full resolution and restoration of service. This may involve workarounds for Critical Issues.
- Uptime Guarantee: The minimum percentage of time that a specified service or system is operational and accessible during a defined period.
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