Covid-19

Material and Device Management for Covid-19 Laboratories

The correct and safe use of materials and equipment in the laboratory, together with good microbiology practices, minimizes the possibility of personnel exposure to biological agents. It should be ensured that the equipment is taken into laboratory operation and used by preserving its safety features.

In the Material and Device Management department, the quality standards that must be applied in laboratories as well as in all departments of the hospital have been determined. According to these standards, the main elements in material and device management are as follows:

• Duties and responsibilities of personnel involved in material and device management
• Determining the need for materials and devices
• Supply of materials and devices
• Material prompts
• Storage of materials
• Transfer of materials
• Safe use of materials and devices
• Material and device inventory tracking
• Methods of intervention in dangerous situations that occur during the use of materials and devices
• Materials and devices of special quality, for special storage conditions or for use requiring special technical/expertise

Equipment Supply and Inclusion in Use

As with other laboratory equipment, during the procurement of the equipment to be used in the COVID-19 testing process, technical, safety, etc. properties must be defined. At the acceptance of the equipment, it should be inspected in terms of its predefined characteristics. The equipment should be placed in an area with the appropriate qualifications and size for safe use, taking into account the technical specifications and manufacturer's recommendations.

Equipment Registration

Equipment identification, manufacturer's name, model and serial number or other unique identification, supplier or manufacturer's contact information, user training certificates, and manufacturer's instructions should be documented.

Providing Training to Personnel on Equipment, Evaluation of Competence

Personnel training at the beginning of the device should be provided by the company and the training should be certified. The device usage competence of the personnel should be evaluated. Personnel must be authorized to use the featured equipment.

Preparation of Documentation Related to Equipment Use and Maintenance

In addition to simple but step-by-step operating instructions, the necessary function checkpoints, maintenance processes, and simple troubleshooting information for the equipment should also be documented.

Device Inventory Creation and Traceability

Although there is an institutional device inventory within the hospital, the laboratory should also have a device inventory within its own body, and care should be taken to ensure that the information is up-to-date and compatible with the hospital inventory. In addition, a device file must be created for each device. The device inventory should contain at least the following information:

• Device name
• Identification number (biomedical number or asset number) that identifies the device
• Serial number
• brand, model
• Current section
• Inventory of medical devices
• It should be traceable through the system defined by the Ministry. In addition, the calibration, maintenance, repair activities, and records of the devices should be traceable.

Covid-19 Equipment Use, Cleaning, Maintenance

A responsible person should be identified for the use and maintenance of each specific piece of equipment used in the COVID-19 testing process.

Laboratory technical personnel must have device usage training and certificates.

Safe working conditions (physical, electrical, climatic, electromagnetic etc. safety) must be provided.

Temperature-related devices should be monitored daily and recorded.

Daily air flow monitoring of biosafety cabinets should be performed and recorded.

Every equipment should have a cleaning and preventive maintenance program.

Electronic, mechanical, operational and functional checks of the equipment should be made periodically and when necessary.

Maintenance-repair records should be kept; troubleshooting activities should be recorded.

Controls and operations of the equipment should be regularly recorded in simple and well-organized charts.

These charts should include fields where the date, control results, acceptable performance limits, comment and the name of the inspector can be written.

Simple maintenance performed daily or in short periods in accordance with the maintenance program should be provided and documented by the personnel using the device, and comprehensive maintenance performed for six-month and longer periods should be provided and documented by the authorized service of the seller company or the technical services with which the institution has a maintenance agreement.

Instruction should be prepared in line with the manufacturer's recommendations regarding the maintenance that laboratory personnel can perform, personnel training should be completed and documented.

The date of opening on the reagents and kits used in the COVID-19 testing process should be written legibly and indelibly.

Outdated reagents should not be used.

Disposable consumables (pipette tips, gloves, plastic pipettes, etc.) should not be reused.

The new reagent (new product, new lot, homemade reagent) must be validated with the old reagent or reference material before use; verification should be done according to a documented procedure.

Calibration

The processes for device calibrations within the hospital are managed by the relevant technical units. In addition, each unit should have information about the maintenance and calibration processes and results of the devices subject to calibration within its own body and follow the process.

In the COVID-19 diagnostic laboratory, as in all laboratories, devices that have been calibrated and approved for use should be available.

Device calibrations should be done by organizations authorized by authorities.

The calibrations of the devices installed against the kit are made by the relevant manufacturer's technical service.

Reference device definition, reference values, reference error, measurement values, and measurement error should be included in the calibration report.

Calibration should be accepted if the measurement values ​​and measurement errors are within reference values ​​and error limits.

For some parameters, it is possible to test the validity of the calibration. It is possible to do this with standard volume and weight sets for straws and balances.

There should be a calibration label showing the next calibration date on the devices.

There should be a defined plan for the calibration processes; When necessary, such as company recommendations, hospital needs, usage intensity, malfunction, and after-care, calibration should be done in a determined manner and frequency.

The laboratory should establish a monitoring method to follow the device calibration and maintenance process within its own body.

During device maintenance and calibration, precautions should be taken with PPE and attention should be paid to minimizing aerosol and droplet formation.

Consumable and Reagent Stock Management

There should be a staff member responsible for laboratory consumables and reagent management.

Delay in delivery of reagents, unsuitable conditions (eg unsuitable temperature), unsuitable specification, etc. should be recorded.

There should be a list of manufacturers and suppliers, suppliers should be evaluated. Having a product catalog can be helpful.

It may be useful to use suppliers in the national registration system.

The quantity received, lot number, quality control, supplier, acceptance date, storage conditions, expiry date / shelf life should be recorded and monitored

Consumable and reagent inspection and acceptance should be performed according to a documented procedure.

Acceptance and rejection criteria should be defined.

Reagents and consumables should be stored under appropriate conditions (temperature, humidity, etc.), storage conditions should be monitored. Reagent and consumable purchases should be recorded.

The usage rate of reagents and consumables should be monitored.

A system that accurately predicts the need for reagents and consumables should be established.

Minimum Equipment Requirements for COVID-19 Diagnostic Laboratories General Laboratory Equipment

The minimum general laboratory equipment required in a laboratory where COVID-19 PCR tests are applied and the minimum specifications of this equipment are given below.

Sample Acceptance Area

Computer

Barcode reader

Medical waste containers, disinfectant

Mixing Preparation Room (Clean room)

BGK-II

Centrifuge, microcentrifuge, vortex

Spin centrifuge (optional)

Refrigerator, freezer

Eppendorf tube, PCR tubes (500µl-1.5ml capped, polypropylene, DNAse RNAse-free)

Color-marked pipette set, DNAse RNAse-free filtered pipette tip

Medical waste containers, liquid waste containers, disinfectant

Extraction Room

BGK-II

Centrifuge, microcentrifuge, vortex

Refrigerator, freezer

Eppendorf tube, PCR tubes

Color-marked pipette set, DNAse RNAse-free filtered pipette tip

Medical waste containers, liquid waste containers, disinfectant

Amplification Room (Dirty Room)

RT-PCR device

spin centrifuge

Power source

Computer

Medical waste containers, liquid waste containers, disinfectant

Analysis and Reporting

Computer

Printer

Medical waste containers, disinfectant

Apart from these, autoclave, personal protective equipment, fire extinguisher and fire blanket, emergency kit, cleaning materials to be used only in the COVID-19 diagnostic test laboratory and UV lamps should also be in the laboratory. In order to ensure the proper and effective use of UV lamps, a lamp with at least 30W should be used on a 18-20 m2 floor area. Ceiling height can be calculated as 1.83W per square meter for 2.44 m. It is predicted that 67J/m2 radiation is sufficient for SARS-CoV-2.

In order to be used in sample transfer and storage processes, there should also be screw-capped cryotubes for sample storage, suitable tube spores, racks, cooling blocks, triple transport containers for sample transfer, nylon or flocked swabs, and viral transport medium.

Special Covid-19Laboratory Equipment

In addition to general laboratory equipment, there is also special laboratory equipment that can be used according to the working method and laboratory facilities. For example, in mixing preparation, it is useful to use a mixing cabinet to provide isolation from the environment, especially if sufficient space for a clean area cannot be provided.

Disinfectant

Disinfectants that comply with Environmental Protection Agency (EPA) criteria should be used in the laboratory environment.

Sodium hypochlorite

1,000 ppm (0.1%) for general surface disinfection

10,000 ppm (1%) for biological spill, disinfection of spills

Alcohol

 62-71%

Hydrogen peroxide

0.5%

Quaternary ammonium compounds

Phenol compounds

Benzalkonium chloride (0.05-0.2%) and chlorhexidine digluconate (0.02%); less effective than others.

Personal Protective Equipment

The minimum quantity and quality of PPE required for personnel working in laboratories where COVID-19 tests are carried out is stated below:

Uniform / lab coat: It should have long sleeves, narrow wrists if possible, long body, up to the knee.

Suitable respiratory mask: EU FFP2 or FFP3 (US N95 or N99)

Powder free gloves

Overalls / boxing shirt: It should be liquid-proof.

disposable apron

Bonnet

Overshoe

Glasses / visor

First aid kit (eye wash and bandage)

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