Embedded Files
NABL Manuals
- Quick list:
TAT, crtloal alert- not more than one hour
Quality assurance
MOU tor outsourced investigations
Spill management
Equipment / furniture maintenance
Immunisation of staff
Patients' rights-respect for value and belief
Cinicopathologioal meeting
Test reports
AMendment of Reports
Lab safety
PPE
BMW
Spill Mangement
Hazmet
Firs safety
Ensures quality of test results
- Turnaround Time (TAT):
Establish clear policies and procedures for determining and meeting TAT for various tests.
Regularly monitor TAT performance and take corrective actions if targets are not met.
Document and communicate TAT expectations to all relevant staff members.
Implement systems for rapid communication of critical results to healthcare providers within the specified time frame (e.g., not more than one hour).
- Quality Assurance:
Develop a comprehensive quality assurance program that includes regular internal audits, proficiency testing, and external quality assessment schemes.
Ensure that all laboratory processes are standardized and documented to maintain consistency and accuracy in test results.
Provide continuous training and education to laboratory staff on quality assurance principles and practices.
Implement corrective and preventive actions (CAPA) for addressing any deviations from quality standards.
- MOU for Outsourced Investigations:
Establish formal agreements (MOUs) with external laboratories or service providers for outsourced investigations.
Define the scope of work, responsibilities, quality assurance requirements, and communication channels in the MOU.
Regularly review and evaluate the performance of outsourced services to ensure compliance with quality standards.
- Spill Management:
Develop protocols for handling spills of hazardous materials in the laboratory environment.
Provide appropriate training to staff members on spill response procedures, including containment, cleanup, and disposal.
Maintain an inventory of spill response equipment and materials, such as absorbents, personal protective equipment (PPE), and spill kits.
Equipment/Furniture Maintenance:
Implement a preventive maintenance program for laboratory equipment and furniture to ensure optimal performance and longevity.
Schedule regular inspections, calibration, and servicing of equipment according to manufacturers' recommendations.
Keep detailed records of maintenance activities, including dates, service providers, and any issues identified.
Immunization of Staff:
Encourage and facilitate immunization of laboratory staff against relevant infectious diseases, as per national guidelines.
Maintain up-to-date records of staff immunization status and provide necessary vaccinations or boosters as required.
Educate staff members on the importance of immunization for their own protection and the prevention of transmission to patients.
Patients' Rights - Respect for Values and Beliefs:
Develop policies and procedures that ensure respect for patients' rights, values, and beliefs throughout the laboratory process.
Provide training to staff members on cultural sensitivity, confidentiality, and informed consent.
Establish mechanisms for patients to express their preferences regarding religious or cultural practices that may impact their healthcare experience.
Clinicopathological Meeting:
Organize regular multidisciplinary meetings involving clinicians, pathologists, and other relevant healthcare professionals to discuss complex cases and treatment strategies.
Document meeting proceedings, including case presentations, discussions, and recommendations for patient management.
Use clinicopathological meetings as an opportunity for continuous learning and quality improvement.
Test Reports:
Standardize the format and content of test reports to ensure clarity, completeness, and accuracy.
Include relevant information such as patient demographics, test results, reference ranges, interpretative comments, and any additional instructions.
Implement procedures for timely delivery of test reports to healthcare providers and patients, including electronic reporting options where available.
Amendment of Reports:
Establish protocols for handling requests for amendments or corrections to laboratory reports.
Document the reasons for amendments and obtain appropriate authorization from authorized personnel.
Ensure that amended reports clearly indicate the changes made and the date of the amendment.
Lab Safety:
Develop and enforce safety policies and procedures to minimize risks to staff, patients, and the environment.
Conduct regular risk assessments to identify hazards and implement control measures.
Provide comprehensive safety training to all laboratory personnel and ensure compliance with safety protocols at all times.
Personal Protective Equipment (PPE):
Provide appropriate PPE to laboratory staff based on the hazards present in the work environment.
Ensure proper fit, use, and disposal of PPE according to manufacturer recommendations and regulatory requirements.
Regularly assess the effectiveness of PPE programs and make adjustments as necessary.
Biomedical Waste Management (BMW):
Develop a comprehensive BMW management plan in accordance with local regulations and guidelines.
Segregate, collect, store, transport, and dispose of biomedical waste safely and responsibly.
Provide training to staff members on BMW handling procedures and ensure compliance with waste management protocols.
Hazardous Materials (Hazmat):
Identify and assess potential hazards associated with hazardous materials used or stored in the laboratory.
Implement appropriate control measures to minimize exposure risks, such as engineering controls, administrative controls, and PPE.
Provide training to staff members on the safe handling, storage, and disposal of hazardous materials.
Fire Safety:
Develop and implement fire safety protocols and evacuation procedures specific to the laboratory setting.
Install and maintain fire detection and suppression systems, including fire extinguishers, smoke detectors, and emergency lighting.
Conduct regular fire drills and training sessions for staff members to ensure preparedness in case of a fire emergency.
Ensuring Quality of Test Results:
Establish and maintain a quality management system that encompasses all aspects of the testing process, from pre-analytical to post-analytical phases.
Implement internal quality control measures to monitor the accuracy and precision of test results.
Participate in external quality assessment programs to benchmark performance and identify areas for improvement.
AAC 1 b,c
Suitable qualified personnel
Service in scope should be defined
AAC 6 a-j
Scope commensurate with services.
Adequate infrastructure and manpower. Qualified personnel
Documented procedures for collection, processing, etc
TAT.
Critical results (of outsourced investigations also) not more than one hour
Reported in a standardised manner. Signatures
Outsourced investigations report
Mechanism for recall / amendment of reports
Quality assurance of outsourced investigations
AAC 7 a-f
Quality assurance programme documented - ILQA - ELQA
Feedback from various stakeholders
Traceability of calibration records to national/international standards
Verification/ validation and LJ graphs / software validation/ surveillance / calibration/maintenance/Corrective and Preventive actions
Calibration of POC equipment also
CAPA
Clinico-pathological meeting
AAC 8 a-d
Documented lab safety programme
Documented policies & procedures for disposal of infectious & hazmat
Awareness of safety among employees Staff trained in safe practice Staff have safety equipment / fire extinguisher/dressing materials/etc.
Immunisation
Reagent storage.
PRE 4 d, g
HIV consent
HIC 2 c-f
Adequate & appropriate PPE
Hand hygiene facilities
Barrier nursing
HIC 3 a-g
Adhering hand hygiene guidelines
Use of PPE
Safe injection practice
HIC 4 a-f
Testing of water quality
Risk stratification matrix for frequency of cleaning
BMW handled appropriately & safely
Laundry and linen management
HIC 8 b, e
Occupational safety
Immunization policy
Implement work restrictions for staff with transmissible infections
Measures for blood and body fluid
FMS 3 e,f
Post exposure prophylaxis
HAZMAT
Spill management- Chemical spill
FMS 3 c
All Equipment are inventoried and log maintained / calibrated
FMS 4 c-f
PM labels on Equipment/calibration records/Refrigerator
FMS 7
Documented plan for handling fire and non-fire emergencies
Safe exit plan. Signage pertaining to fire exits
Open and easily accessible fire exits without any obstruction
Smoke detectors, fire alarms, fire alarm control panel etc. Fire exit, fire extinguishers, no smoking signs etc.
IMS 4 c
Test results are there in case sheets
Staff interview
Data collection for quality indicators to be verified:
PSQ 3a (2): Number of reporting error
PSQ 3a (3): Percentage of adherence to safety precautions by staff working in diagnostics
PSQ 4c (23): Waiting time for diagnostic
AAC 1b,c:
AAC 1b,c:
- Suitable Qualified Personnel:
Define qualification criteria for personnel involved in laboratory activities, including education, training, and experience.
Ensure that all staff members meet the specified qualification requirements for their respective roles.
Maintain records of staff qualifications, training, and competency assessments.
- Service in Scope Should Be Defined:
Clearly define the scope of services offered by the laboratory, including types of tests, specialties, and any limitations.
Document the scope of services in written policies and procedures for reference by staff and stakeholders.
Regularly review and update the scope of services as needed to reflect changes in technology, resources, or organizational priorities.
AAC 6a-j:
AAC 6a-j:
- Scope Commensurate with Services:
Ensure that the laboratory's scope of activities aligns with its defined services and capabilities.
Regularly assess and review the laboratory's scope to ensure it remains appropriate and relevant.
Document any expansions or modifications to the scope of services and communicate them to relevant stakeholders.
- Adequate Infrastructure and Manpower:
Assess and ensure the availability of adequate physical infrastructure, including facilities, equipment, and space, to support laboratory operations.
Determine staffing requirements based on the workload, complexity of tests, and service demands.
Maintain an appropriate ratio of qualified personnel to workload to ensure timely and accurate testing.
- Documented Procedures for Collection, Processing, etc.:
Develop and maintain documented procedures for all laboratory processes, including sample collection, processing, analysis, and reporting.
Ensure that procedures are standardized, validated, and accessible to all staff members.
Regularly review and update procedures to incorporate best practices and quality improvements.
- Turnaround Time (TAT):
Establish target turnaround times for different types of tests based on clinical significance and operational feasibility.
Monitor TAT performance regularly and implement measures to minimize turnaround delays.
Communicate TAT expectations to staff and stakeholders and provide feedback on performance.
- Critical Results (of Outsourced Investigations Also) Not More Than One Hour:
Define critical results criteria and establish protocols for rapid communication of critical results to healthcare providers.
Ensure that critical results from outsourced investigations are communicated within the specified time frame.
Document critical result reporting procedures and regularly audit compliance with the one-hour timeframe.
- Reported in a Standardized Manner:
Standardize the format and content of laboratory reports to ensure consistency, clarity, and accuracy.
Include essential information such as patient demographics, test results, reference ranges, interpretive comments, and signatures.
Implement procedures to verify the accuracy and completeness of reports before release.
- Outsourced Investigations Report:
Establish agreements with external laboratories or service providers for outsourced investigations, including requirements for reporting.
Review and approve outsourced investigation reports to ensure quality and compliance with standards.
Document procedures for handling and integrating outsourced reports into the laboratory's records.
- Mechanism for Recall/Amendment of Reports:
Develop protocols for recalling or amending laboratory reports in the event of errors, discrepancies, or patient safety concerns.
Implement mechanisms for identifying and investigating report discrepancies and initiating corrective actions.
Maintain records of report recalls, amendments, and associated corrective actions.
- Quality Assurance of Outsourced Investigations:
Establish quality assurance processes to monitor and evaluate the performance of external laboratories or service providers.
Conduct regular assessments of outsourced investigation quality, including proficiency testing and audit activities.
Provide feedback and guidance to outsourced providers to address any identified deficiencies and improve quality.
AAC 7a-f:
AAC 7a-f:
- Quality Assurance Programme Documented - ILQA - ELQA:
Document the laboratory's quality assurance program, including policies, procedures, and quality objectives.
Implement internal quality control (ILQA) and external quality assessment (ELQA) programs to monitor and improve performance.
Ensure that quality assurance activities are documented, tracked, and reviewed regularly for effectiveness.
- Feedback from Various Stakeholders:
Solicit feedback from patients, healthcare providers, and other stakeholders on laboratory services and performance.
Use feedback mechanisms such as surveys, suggestion boxes, and complaint management systems to capture stakeholder input.
Analyze feedback data to identify areas for improvement and implement corrective actions as needed.
- Traceability of Calibration Records to National/International Standards:
Maintain calibration records for laboratory equipment and instruments, including traceability to national or international standards.
Conduct regular calibrations and performance verification checks to ensure accuracy and reliability.
Document calibration procedures, results, and any adjustments made during the process.
- Verification/Validation and LJ Graphs/Software Validation/Surveillance/Calibration/Maintenance/Corrective and Preventive Actions:
Verify and validate laboratory methods, equipment, and software to ensure accuracy, reliability, and compliance with standards.
Use LJ (Levey-Jennings) graphs or other statistical tools for monitoring and interpreting quality control data.
Implement surveillance programs to detect and prevent errors, deviations, or non-conformities.
Perform regular maintenance, calibration, and corrective/preventive actions to maintain quality and compliance.
- Calibration of POC Equipment Also:
Include point-of-care (POC) equipment in the laboratory's calibration and maintenance program.
Ensure that POC devices are calibrated, verified, and maintained according to manufacturers' recommendations and regulatory requirements.
Provide training to staff members on proper POC equipment use, maintenance, and quality control procedures.
- CAPA:
Implement a systematic process for identifying, investigating, and resolving non-conformities and quality issues.
Document corrective and preventive actions (CAPA) taken in response to quality incidents, deviations, or audit findings.
Monitor the effectiveness of CAPA measures and make adjustments as needed to prevent recurrence.
AAC 8a-d:
AAC 8a-d:
- Documented Lab Safety Programme:
Develop and maintain a comprehensive laboratory safety program that addresses potential hazards, risks, and emergency procedures.
Document safety policies, procedures, and protocols for handling hazardous materials, spills, accidents, and emergencies.
Ensure that all staff members are trained in laboratory safety practices and procedures.
- Documented Policies & Procedures for Disposal of Infectious & Hazmat:
Establish protocols for the safe handling, storage, and disposal of infectious materials and hazardous waste generated in the laboratory.
Document procedures for waste segregation, packaging, labeling, and transportation in compliance with regulatory requirements.
Provide training to staff members on waste management practices and ensure proper disposal procedures are followed.
- Awareness of Safety Among Employees:
Promote a culture of safety awareness and compliance among all laboratory staff members.
Conduct regular safety training sessions, drills, and workshops to reinforce safety practices and procedures.
Encourage active participation and feedback from employees in improving safety measures.
- Staff Trained in Safe Practice:
Ensure that all laboratory staff members receive comprehensive training in safe work practices, including handling of hazardous materials, use of personal protective equipment (PPE), and emergency response.
Document training records and periodically assess staff competency in safety procedures.
PRE 4d, g:
PRE 4d, g:
- HIV Consent:
Obtain informed consent from patients before conducting HIV testing or handling HIV-related specimens.
Provide clear information to patients about the purpose of HIV testing, potential risks and benefits, confidentiality, and their rights.
Document patient consent in accordance with legal and ethical requirements.
HIC 2c-f:
HIC 2c-f:
- Adequate & Appropriate PPE:
Provide appropriate personal protective equipment (PPE) to laboratory staff based on the hazards present in the work environment.
Ensure that PPE is properly fitted, maintained, and used according to manufacturer instructions and safety protocols.
Regularly assess PPE needs and provide training on its proper selection, use, and disposal.
- Hand Hygiene Facilities:
Ensure the availability of hand hygiene facilities, including sinks, soap, water, and hand sanitizer, in the laboratory area.
Promote hand hygiene practices among staff members and visitors to prevent the spread of infections.
Monitor and maintain hand hygiene facilities to ensure accessibility and functionality.
- Barrier Nursing:
Implement barrier nursing practices to prevent the transmission of infectious agents between patients and healthcare workers.
Provide training to staff members on barrier nursing techniques, including the use of personal protective equipment (PPE) and isolation precautions.
Regularly assess and reinforce adherence to barrier nursing protocols to minimize the risk of healthcare-associated infections.
HIC 3 a-g:
HIC 3 a-g:
- Adhering Hand Hygiene Guidelines:
Promote and enforce adherence to hand hygiene guidelines recommended by health authorities, such as the World Health Organization (WHO).
Provide education and training to staff on proper hand hygiene techniques, including the use of soap and water or alcohol-based hand sanitizers.
Monitor compliance with hand hygiene protocols through regular audits and feedback mechanisms.
- Use of PPE:
Ensure that appropriate personal protective equipment (PPE) is available and used correctly by staff according to the nature of the task and potential hazards.
Provide training on the selection, use, and disposal of PPE, including gloves, masks, goggles, and gowns.
Conduct regular assessments of PPE usage and availability to address any deficiencies.
- Safe Injection Practice:
Implement and enforce safe injection practices to prevent healthcare-associated infections and needlestick injuries.
Provide training to staff on proper injection techniques, including needle safety, aseptic procedures, and single-use equipment disposal.
Monitor adherence to safe injection practices through audits and observation.
HIC 4 a-f:
HIC 4 a-f:
- Testing of Water Quality:
Conduct regular testing of water quality in the healthcare facility to ensure safety and compliance with regulatory standards.
Monitor parameters such as microbiological contamination, chemical pollutants, and pH levels.
Take corrective actions in case of water quality deviations and maintain records of testing results.
- Risk Stratification Matrix for Frequency of Cleaning:
Develop a risk stratification matrix to determine the frequency and intensity of cleaning and disinfection activities in different areas of the healthcare facility.
Consider factors such as patient population, type of services provided, and potential infection risks.
Review and update the cleaning schedule based on changes in risk factors or emerging infectious threats.
- BMW Handled Appropriately & Safely:
Establish protocols for the safe handling, segregation, collection, storage, and disposal of biomedical waste (BMW) generated in the healthcare facility.
Ensure compliance with regulatory requirements for BMW management, including proper labeling, packaging, and transportation.
Provide training to staff on BMW handling procedures and implement monitoring mechanisms to ensure adherence.
- Laundry and Linen Management:
Develop procedures for the safe handling, laundering, and storage of healthcare facility linens to prevent cross-contamination and infection transmission.
Ensure that laundry processes meet hygiene standards and guidelines for infection control.
Monitor and audit laundry practices to maintain quality and compliance with established protocols.
HIC 8 b, e:
HIC 8 b, e:
- Occupational Safety:
Implement occupational safety measures to protect healthcare workers from workplace hazards and injuries.
Conduct risk assessments to identify occupational health risks and implement control measures to mitigate them.
Provide training, resources, and support to promote a safe work environment and prevent occupational injuries and illnesses.
- Immunization Policy:
Develop and implement an immunization policy for healthcare workers to protect them from vaccine-preventable diseases.
Ensure that all staff members receive appropriate vaccinations and boosters according to national immunization guidelines and occupational health requirements.
Maintain immunization records and provide access to vaccination services.
- Implement Work Restrictions for Staff with Transmissible Infections:
Establish protocols for managing healthcare workers with transmissible infections to prevent the spread of disease to patients and colleagues.
Provide guidance on work restrictions, including temporary reassignment, leave, or modified duties, based on the nature of the infection and public health recommendations.
Ensure confidentiality and non-discrimination in the management of staff health issues.
- Measures for Blood and Body Fluid:
Implement standard precautions for the handling of blood and body fluids to prevent exposure to infectious agents.
Provide training on safe work practices, personal protective equipment (PPE) use, and post-exposure protocols.
Establish procedures for the prompt assessment, management, and reporting of blood and body fluid exposures.
FMS 3 e,f:
FMS 3 e,f:
- Post Exposure Prophylaxis:
Develop protocols for the management of occupational exposures to bloodborne pathogens, including post-exposure prophylaxis (PEP) administration.
Ensure timely access to PEP treatment and follow-up care for healthcare workers who experience potential exposures.
Provide education and training on the importance of reporting exposures and seeking medical evaluation promptly.
- HAZMAT:
Identify hazardous materials (HAZMAT) used or stored in the healthcare facility and implement appropriate handling, storage, and disposal procedures.
Provide training to staff on the safe use of hazardous substances, emergency response protocols, and the use of personal protective equipment (PPE).
Conduct regular inspections and risk assessments to minimize the risk of exposure to hazardous materials.
- Spill Management - Chemical Spill:
Develop protocols for the safe management of chemical spills in healthcare facilities, including containment, cleanup, and disposal procedures.
Provide training to staff on spill response protocols, including hazard identification, evacuation procedures, and use of spill kits.
Maintain an inventory of spill response equipment and materials and conduct regular drills to ensure readiness.
FMS 3 c:
FMS 3 c:
- All Equipment are Inventoried and Log Maintained/Calibrated:
Maintain an inventory of all equipment used in the healthcare facility, including medical devices, instruments, and machinery.
Document equipment details, including make, model, serial number, and location, in a centralized inventory system.
Implement a schedule for equipment calibration, maintenance, and servicing, and keep detailed records of these activities.
FMS 4 c-f:
FMS 4 c-f:
- PM Labels on Equipment/Calibration Records/Refrigerator:
Label medical equipment with preventive maintenance (PM) schedules and due dates to ensure timely servicing and calibration.
Maintain calibration records for equipment, including dates of calibration, results, and any adjustments made.
Ensure that refrigerators and other temperature-controlled storage units are monitored and calibrated regularly to maintain proper temperature settings.
FMS 7:
FMS 7:
- Documented Plan for Handling Fire and Non-Fire Emergencies:
Develop comprehensive emergency response plans for managing fire and non-fire emergencies in the healthcare facility.
Include protocols for evacuation, shelter-in-place, medical emergencies, hazardous material spills, and other potential incidents.
Communicate emergency procedures to staff through training sessions, drills, and signage.
- Safe Exit Plan. Signage Pertaining to Fire Exits:
Ensure that fire exits are clearly marked with appropriate signage and kept unobstructed at all times.
Develop and communicate evacuation routes and procedures to staff, patients, and visitors.
Conduct regular fire drills to practice evacuation procedures and assess staff readiness.
- Open and Easily Accessible Fire Exits Without Any Obstruction:
Maintain clear access to fire exits by keeping pathways and exits free from obstructions, clutter, or storage.
Ensure that emergency exit doors are unlocked, operable, and equipped with panic hardware for easy egress.
Regularly inspect and maintain fire exit routes to ensure compliance with safety regulations.
- Smoke Detectors, Fire Alarms, Fire Alarm Control Panel, etc.:
Install and maintain smoke detectors, fire alarms, and fire alarm control panels in accordance with fire safety regulations.
Test smoke detectors and alarms regularly to ensure proper functioning and sensitivity.
Provide training to staff on fire alarm activation procedures and evacuation protocols.
IMS 4 c:
IMS 4 c:
- Test Results are There in Case Sheets:
Ensure that all test results are accurately recorded and documented in patient case sheets or electronic health records.
Implement procedures for verifying and validating test results before entry into patient records to prevent errors or omissions.
Maintain confidentiality and security of patient information in accordance with privacy regulations.
- Staff Interview:
Conduct interviews with staff members to assess their knowledge, skills, attitudes, and compliance with quality and safety protocols.
Use structured interview techniques and standardized assessment tools to gather information consistently.
Provide feedback to staff based on interview findings and identify opportunities for improvement or training.
Data Collection for Quality Indicators to Be Verified:
Data Collection for Quality Indicators to Be Verified:
PSQ 3a (2): Number of Reporting Error:
PSQ 3a (2): Number of Reporting Error:
Collect data on the number of reporting errors, including mislabeling, transcription errors, and documentation discrepancies.
Analyze reporting error trends over time to identify root causes and implement corrective actions to prevent recurrence.
Provide feedback to staff on the importance of accurate reporting and documentation.
PSQ 3a (3): Percentage of Adherence to Safety Precautions by Staff Working in Diagnostics:
PSQ 3a (3): Percentage of Adherence to Safety Precautions by Staff Working in Diagnostics:
Monitor staff adherence to safety precautions through direct observation, audits, and self-assessment surveys.
Establish performance indicators and benchmarks for safety compliance and track progress over time.
Provide ongoing education and training to promote a culture of safety and reinforce adherence to safety protocols.
PSQ 4c (23): Waiting Time for Diagnostic:
PSQ 4c (23): Waiting Time for Diagnostic:
Measure waiting times for diagnostic services from patient arrival to test completion and result reporting.
Identify factors contributing to delays in diagnostic testing and implement process improvements to reduce waiting times.
Communicate waiting time expectations to patients and manage their expectations through effective communication and scheduling practices.
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