1. Patient Safety General Requirements

• Risk Management: Implement a risk management process to identify, assess, and control risks related to phlebotomy procedures.
• Informed Consent: Ensure patients are informed about the procedure and provide their consent.
• Identification: Verify the patient’s identity before performing the procedure.
• Infection Control: Follow infection control protocols to prevent cross-contamination and infection.

2. Use of Devices for Collection Equipment and Devices

• Selection of Devices: Use devices that are appropriate for the type of sample and the patient’s condition (e.g., pediatric, geriatric).
• Maintenance and Calibration: Ensure collection devices are properly maintained and calibrated according to the manufacturer’s instructions.
• Sterility: Use sterile devices and materials to prevent contamination.
• Disposal: Dispose of used collection devices safely and in accordance with local regulations.

3. Toilets Facilities

• Availability: Provide accessible and clean toilet facilities for patients.
• Hygiene: Ensure toilets are equipped with necessary hygiene supplies (e.g., soap, hand sanitizer, paper towels).
• Privacy: Maintain patient privacy in toilet facilities.

1. Laboratory Quality and Safety Requirements1. Internal Quality Control (Internal QC) - (AAC7)

• Purpose: To monitor the accuracy and precision of laboratory test results.
• Requirements:
  • Establish and maintain a robust internal QC program.
  • Use control materials appropriate for the tests being conducted.
  • Regularly review QC results and take corrective actions when needed.
  • Document all QC activities and outcomes.

2. External Quality Control (External QC) - (AAC7)

• Purpose: To ensure the accuracy and comparability of test results with external standards.
• Requirements:
  • Participate in external quality assessment schemes (EQAS) relevant to the tests performed.
  • Compare laboratory results with external standards and peers.
  • Review and address any discrepancies identified through external QC.
  • Maintain records of participation and results from external QC programs.

3. Test Surveillance (AAC7)

• Purpose: To continually monitor the performance of laboratory tests.
• Requirements:
  • Implement ongoing surveillance of test performance metrics.
  • Use statistical methods to analyze test data for trends and outliers.
  • Conduct regular reviews of test performance.
  • Adjust testing processes based on surveillance findings to ensure accuracy and reliability.

4. Safety Equipment (AAC8)

• Purpose: To protect laboratory personnel from potential hazards.
• Requirements:
  • Provide appropriate safety equipment such as gloves, goggles, lab coats, and face shields.
  • Ensure that safety equipment is easily accessible and in good working condition.
  • Conduct regular training on the proper use of safety equipment.
  • Maintain records of safety equipment inspections and maintenance.

5. Cross Contamination Prevention (AAC7)

• Purpose: To prevent contamination between samples and reagents.
• Requirements:
  • Design and implement protocols to avoid cross-contamination.
  • Use dedicated workspaces and equipment for different types of samples.
  • Train staff on techniques to minimize contamination risks.
  • Regularly audit practices to ensure compliance with contamination prevention protocols.

6. Biosafety Cabinets (AAC8)

• Purpose: To provide a controlled environment for handling biohazardous materials.
• Requirements:
  • Use biosafety cabinets appropriate for the risk level of the materials handled.
  • Ensure regular maintenance and certification of biosafety cabinets.
  • Train personnel on proper use and maintenance of biosafety cabinets.
  • Document all maintenance and certification activities.

7. Material Safety Data Sheets (MSDS) Available Onsite (AAC8)

• Purpose: To provide critical safety information about hazardous materials.
• Requirements:
  • Maintain up-to-date MSDS for all hazardous materials used in the laboratory.
  • Ensure MSDS are easily accessible to all laboratory staff.
  • Train staff on the information contained in MSDS and how to use them in case of emergencies.
  • Regularly review and update MSDS records.

8. Risk Analysis/Risk-Based Approach

• Purpose: To identify, evaluate, and mitigate risks associated with laboratory activities.
• Requirements:
  • Implement a systematic process for risk analysis and management.
  • Conduct regular risk assessments for all laboratory processes.
  • Develop and implement mitigation strategies for identified risks.
  • Document risk analysis activities and outcomes.
  • Continuously review and update risk management plans based on new information or changes in laboratory activities.

1. Radiation Safety and Screening Before Study (AAC 11c)

• Purpose: To ensure the safety of patients and staff by minimizing exposure to radiation.
• Requirements:
  • Conduct thorough screening to assess the necessity and appropriateness of the radiological study.
  • Evaluate patient history and previous exposures to avoid unnecessary radiation.
  • Use radiation dose management strategies to keep exposure as low as reasonably achievable (ALARA).

2. Informed Consent (AAC)

• Purpose: To obtain patient consent before administering contrast injections, moderate-to-deep sedation, or interventional procedures.
• Requirements:
  • Provide comprehensive information about the procedure, including risks, benefits, and alternatives.
  • Obtain and document informed consent from the patient or their legal representative.
  • Ensure the consent process is conducted in a manner that respects the patient’s rights and understanding.

3. Appropriate Investigations

• Purpose: To ensure that radiological investigations are justified and appropriate for the clinical indications.
• Requirements:
  • Review clinical indications and select the most suitable imaging modality.
  • Avoid unnecessary or redundant imaging studies.
  • Ensure investigations are aligned with current clinical guidelines and standards.

4. ALARA (As Low As Reasonably Achievable) - (AAC 11a)

• Purpose: To minimize radiation exposure to patients and staff.
• Requirements:
  • Implement policies and procedures to keep radiation doses as low as possible.
  • Use appropriate shielding, positioning, and technique factors.
  • Regularly review and update protocols to ensure adherence to ALARA principles.

5. MSDS (Material Safety Data Sheets) Available Onsite - (AAC 11)

• Purpose: To provide safety information about hazardous materials used in radiology.
• Requirements:
  • Maintain up-to-date MSDS for all contrast agents and chemicals.
  • Ensure MSDS are easily accessible to all staff.
  • Train staff on the information contained in MSDS and emergency procedures.

6. Employees with Appropriate Radiation Safety and Monitoring Devices - (AAC 11e)

• Purpose: To protect radiology staff from radiation exposure.
• Requirements:
  • Equip employees with personal dosimeters and other radiation monitoring devices.
  • Ensure proper usage and maintenance of these devices.
  • Regularly review dose records to monitor cumulative exposure.

7. Periodical Testing of Radiation Safety and Monitoring Devices - (AAC 11f)

• Purpose: To ensure the accuracy and functionality of radiation safety equipment.
• Requirements:
  • Conduct regular testing and calibration of radiation monitoring devices.
  • Maintain records of testing and calibration activities.
  • Address any issues identified during testing promptly.

8. Warning Signage - (AAC 11h)

• Purpose: To alert staff and patients to radiation hazards.
• Requirements:
  • Display clear and visible warning signs in areas where radiation is used.
  • Ensure signage meets regulatory and safety standards.
  • Regularly inspect and maintain warning signs.

9. Working Condition of Warning Lights - (AAC 11h)

• Purpose: To indicate the presence of active radiation sources.
• Requirements:
  • Ensure warning lights are functioning correctly and are clearly visible.
  • Regularly test and maintain warning lights.
  • Address any malfunctions immediately.

10. Training in Imaging Safety Practices and Radiation Safety Measures - (AAC 11g)

• Purpose: To ensure staff are knowledgeable and competent in radiation safety.
• Requirements:
  • Provide regular training on radiation safety, imaging practices, and emergency procedures.
  • Document all training activities and assess competency.
  • Keep staff updated on new safety guidelines and best practices.

1. Annual Review of LASA (Look-Alike, Sound-Alike) Medications

• Purpose: To reduce medication errors due to confusion between similar-looking or sounding medications.
• Requirements:
  • Conduct an annual review of the LASA medications used in the organization.
  • Implement strategies to minimize the risk of errors, such as distinct labeling, separate storage, and staff training.
  • Document the review process and any actions taken.

2. Storage of Medication (MOM 3b)

• Purpose: To ensure medications are stored under appropriate conditions to maintain their efficacy and safety.
• Requirements:
  • Monitor and control the temperature of refrigerators and rooms where medications are stored.
  • Ensure proper lighting, ventilation, and pest control in storage areas.
  • Regularly inspect storage conditions and maintain records of temperature and environmental conditions.

3. Medication Orders in Capital Letters (MOM 4g)

• Purpose: To improve the legibility of medication orders and reduce the risk of errors.
• Requirements:
  • Write all medication orders in capital letters.
  • Train staff on the importance of legible medication orders and standardize this practice across the organization.

4. Medicine Dispensing Procedure (MOM 5e, f)

• Purpose: To ensure accurate and safe dispensing of medications.
• Requirements:
  • Implement standardized procedures for labeling and verifying medications before dispensing.
  • Include details such as patient name, medication name, dosage, and administration instructions on labels.
  • Conduct verification checks to ensure the correct medication is dispensed.

5. Double-Checks for Selected High-Alert Medications

• Purpose: To prevent errors with high-risk medications.
• Requirements:
  • Implement double-check procedures for high-alert medications.
  • Ensure that two qualified individuals independently verify the medication before administration.
  • Document the double-check process.

6. Handling Narcotic Drugs (MOM 9a, b, c, d)

• Purpose: To ensure the secure handling, usage, and disposal of narcotic drugs.
• Requirements:
  • Use a lock and key system for storing narcotic drugs.
  • Maintain detailed records of usage, administration, and disposal of narcotics.
  • Conduct regular audits to ensure compliance with regulatory requirements.
  • Train staff on proper handling and documentation procedures.

7. Biosafety Cabinet

• Purpose: To provide a safe environment for handling hazardous medications and materials.
• Requirements:
  • Use biosafety cabinets when preparing hazardous medications.
  • Ensure regular maintenance and certification of the biosafety cabinets.
  • Train staff on the proper use of biosafety cabinets.

8. Verification of the Condition of Medical Supplies and Consumables Before Dispensing and Usage (MOM 13e)

• Purpose: To ensure the quality and safety of medical supplies and consumables.
• Requirements:
  • Inspect medical supplies and consumables for any signs of damage, contamination, or discoloration before dispensing.
  • Verify that packaging is intact and materials are in good condition.
  • Document the verification process and take corrective actions if any issues are identified.

1. Updating Hospital Infection Prevention and Control Programme (HIC 1b)

• Purpose: To ensure that infection prevention and control practices are based on the latest evidence and guidelines.
• Requirements:
  • Review and update the infection prevention and control program annually.
  • Incorporate new literature, infection trends, outbreak prevention mechanisms, and audit outcomes into the program.
  • Document the review process and any changes made to the program.

2. Infection Control Practices in High-Risk Areas (HIC 2a)

• Purpose: To implement specific infection control measures in areas with a higher risk of HAIs.
• Requirements:
  • Identify high-risk areas within the hospital (e.g., intensive care units, surgical wards).
  • Implement enhanced infection control practices, including increased surveillance, stricter isolation measures, and more frequent cleaning and disinfection.

3. Transmission-Based Precautions (HIC 2d)

• Purpose: To prevent the transmission of infectious agents between patients and healthcare workers.
• Requirements:
  • Implement appropriate personal protective equipment (PPE) based on the mode of transmission (e.g., contact, droplet, airborne precautions).
  • Train staff on the proper use of PPE and adherence to transmission-based precautions.

4. Adherence to Cleaning, Disinfection, and Sterilization Practices (HIC 2f)

• Purpose: To maintain a clean and safe healthcare environment.
• Requirements:
  • Follow standardized cleaning, disinfection, and sterilization protocols.
  • Ensure proper dilution factors and methodologies are used for cleaning and disinfection.
  • Regularly monitor and audit cleaning practices to ensure adherence to protocols.

5. Antibiotic Policy Documentation (HIC 2g)

• Purpose: To promote rational antibiotic use and reduce the risk of antibiotic resistance.
• Requirements:
  • Document and communicate hospital policies on antibiotic use.
  • Implement strategies for antibiotic stewardship, including guidelines for prescribing, monitoring, and reviewing antibiotic therapy.

6. Adherence to Housekeeping Procedures (HIC 2l)

• Purpose: To maintain cleanliness and hygiene in patient care areas.
• Requirements:
  • Ensure proper terminal cleaning, including blood and body fluid cleanup.
  • Implement procedures for cleaning and disinfecting isolation rooms and other high-risk areas.
  • Train housekeeping staff on proper cleaning techniques and infection control measures.

7. Adherence to Laundry and Linen Management Process (HIC 2i)

• Purpose: To prevent the spread of infections through contaminated linens.
• Requirements:
  • Follow established procedures for handling, laundering, and storing linens.
  • Ensure proper segregation of contaminated and clean linens to prevent cross-contamination.

8. Adherence to Kitchen Sanitation and Food-Handling Issues (HIC 2j)

• Purpose: To prevent foodborne illnesses and contamination of food supplies.
• Requirements:
  • Maintain high standards of sanitation in the hospital kitchen and food preparation areas.
  • Train kitchen staff on proper food handling, storage, and hygiene practices.
  • Implement monitoring and auditing processes to ensure compliance with food safety regulations.

9. Water Quality (HIC 2k)

• Purpose: To ensure the safety and cleanliness of water used in patient care and hospital facilities.
• Requirements:
  • Regularly test and monitor water quality, including temperature, pH, and microbial content.
  • Implement water treatment measures as needed to maintain quality standards.

1. Air Conditioning Plant and Equipment Maintenance

• Purpose: To maintain optimal indoor air quality and temperature control.
• Requirements:
  • Regular maintenance of air conditioning plants and equipment.
  • Inspection and cleaning of AC ducts, filters, and air handling units (AHUs) to prevent contamination and improve air quality.

2. Seepage Leading to Fungal Colonization

• Purpose: To prevent fungal growth and contamination due to water seepage.
• Requirements:
  • Identify and repair sources of water seepage to prevent fungal colonization.
  • Conduct regular inspections of building structures for signs of water damage and mold growth.

3. Working Condition of Fire Safety Equipment (FMS 1b)

• Purpose: To ensure readiness for fire emergencies and protect occupants from harm.
• Requirements:
  • Regular inspection and testing of fire safety equipment such as fire extinguishers, fire alarms, and sprinkler systems.
  • Prompt repair or replacement of faulty equipment to maintain operational readiness.

4. 24-Hour Availability of Potable Water and Electricity (FMS 2f)

• Purpose: To ensure continuous access to essential utilities for patient care and facility operations.
• Requirements:
  • Ensure uninterrupted availability of potable water and electricity 24 hours a day.
  • Implement backup systems or contingency plans to mitigate disruptions in service.

5. Calibration of Equipment (FMS 3e)

• Purpose: To maintain the accuracy and reliability of medical and laboratory equipment.
• Requirements:
  • Establish a schedule for the calibration of all equipment according to manufacturer recommendations and regulatory requirements.
  • Document calibration activities, including dates, results, and any adjustments made.

6. Handling, Storage, Distribution, and Usage of Medical Gases (FMS 5b)

• Purpose: To ensure the safe and reliable supply of medical gases for patient care.
• Requirements:
  • Adhere to guidelines for the handling, storage, distribution, and usage of medical gases.
  • Implement safety measures to prevent leaks, contamination, and mix-ups.
  • Train staff on proper procedures for handling and using medical gases safely.

7. Availability of Alternate Source of Medical Gases in Case of Failure (FMS 5d)

• Purpose: To maintain continuity of care in the event of a failure in the primary medical gas supply.
• Requirements:
  • Have contingency plans in place for the availability of alternate sources of medical gases (e.g., vacuum, compressed air) during emergencies or equipment failures.

8. Storage and Handling of Hazardous Material (FMS 7b)

• Purpose: To ensure the safe storage and handling of hazardous materials to protect staff and patients from harm.
• Requirements:
  • Implement procedures for the safe storage and handling of hazardous materials.
  • Provide appropriate training to staff on the proper handling and disposal of hazardous materials.
  • Maintain records of hazardous materials usage, storage, and disposal.

1. Warning Signage in Bilingual Language (FMS 1b)

• Purpose: To ensure clear communication and safety instructions are accessible to all patients, staff, and visitors.
• Requirements:
  • Display warning signage in at least two languages, including the local language and an additional widely understood language.
  • Ensure signage is clear, legible, and positioned in visible locations.

2. Assisted Toilets with Grab Bars (COP 10c/FMS 1b)

• Purpose: To provide safe and accessible restroom facilities for patients with mobility issues.
• Requirements:
  • Equip assisted toilets with grab bars to support patients with limited mobility.
  • Ensure grab bars are securely installed and regularly inspected for safety.

3. Wheelchair with Safety Belts (Patient Transport Procedure) (FMS 1b)

• Purpose: To ensure the safe transport of patients within the facility.
• Requirements:
  • Provide wheelchairs equipped with safety belts to secure patients during transport.
  • Train staff on the proper use and maintenance of wheelchairs and safety belts.

4. Trolley with Side Rails (Patient Transport Procedure) (FMS 1b)

• Purpose: To prevent patient falls and injuries during transport.
• Requirements:
  • Use trolleys with side rails for transporting patients.
  • Regularly inspect and maintain trolleys to ensure side rails are functional and secure.

5. Working Condition of Bed Rails / Call Bells

• Purpose: To ensure patient safety and prompt response to patient needs.
• Requirements:
  • Regularly inspect and maintain bed rails to ensure they are functional and safe.
  • Ensure call bells are in working condition and accessible to patients at all times.

6. Open Electrical Wires

• Purpose: To prevent electrical hazards and ensure safety.
• Requirements:
  • Regularly inspect the facility for exposed or open electrical wires.
  • Promptly repair or replace damaged wiring to eliminate safety risks.

7. Visitors Education

• Purpose: To educate visitors on facility policies, infection control practices, and safety procedures.
• Requirements:
  • Provide clear and concise educational materials for visitors.
  • Ensure visitors are informed about hand hygiene, restricted areas, and emergency procedures.

8. Exposed / Opened Biomedical Waste (BMW)

• Purpose: To prevent exposure to hazardous waste and ensure proper disposal.
• Requirements:
  • Ensure all biomedical waste is properly contained and not exposed or left open.
  • Train staff on proper segregation, handling, and disposal of biomedical waste.