Quality manual

5.3 Laboratory Equipment, Reagents and Consumables

Laboratory equipment includes hardware and software of instruments, measuring systems and laboratory information systems.
Reagents include reference materials, calibrators and quality control materials, consumables media, pipette tips, glass slides etc.
5.3.1 Equipment
5.3.1.1 General
The Department of Pathology is furnished with all items of equipment required for the provision of service, including primary sample collection, sample preparation, sample processing, examination and storage. Equipment is procured and managed as described in MP-GEN-0009 Procurement and Management of Equipment and

MP-GEN-0016 Management and Review of Contracts.
In the selection of equipment, it is endeavoured to take account of energy efficiency rating and future disposal, as outlined in ED-GEN-0136 HSE Procurement Policy and MP-GEN-0017 Procurement and Management of Equipment.
In cases where the laboratory needs to use equipment outside its permanent control, laboratory management ensures that the requirements of ISO 15189 are met.
The laboratory replaces equipment as needed to ensure the quality of examination results.
5.3.1.2 Equipment Acceptance Testing
To demonstrate capability of achieving the performance required and compliance with specifications relevant to the examinations concerned, each piece of equipment and test method is validated. This includes the Installation Qualification (IQ) and Operational Qualification (OQ), to ensure that the equipment is capable of achieving the performance required upon installation and in routine use.
Equipment that was in place prior to implementation of the Quality Management System is retrospectively validated, while all new equipment is validated prior to use. This is carried out as documented in VMP-GEN-0001 Validation Master Plan and LP-GEN-0009 Equipment Validation. LF-BT-0106 Blood Transfusion Instrument List details all equipment in use in the Blood Bank, LF-HAEM-0005 Haematology Instrumentation Index details the equipment in use in the Haematology Department. LP-BIO-0001 Operation and Maintenance of the Abbott Architect CI8200 Analyser details the use of the main analyser in the Biochemistry Department. QF-MIC-0002 Microbiology Instrumentation Index details the equipment used in the Microbiology Department.
VMP-GEN-0001 Validation Master Plan outlines the strategy for establishing, implementing and maintaining an effective calibration and maintenance programme. This ensures that instruments, equipment and systems in use in the Blood Bank, Haematology and Biochemistry are maintained, calibrated and re-qualified as required, thus ensuring fitness for use and maintenance of their validated state. As part of this plan, all equipment undergoes routine calibration and preventative maintenance at a minimum every 12 months and is carried out by external suppliers.
Decommissioning of equipment will be managed as per MP-GEN-0019 Management of Change Control to ensure that there is an end of life check performed before taking the unit out of use. A formal decommissioning plan for the equipment/system/ process will be required at the point of decommissioning. This is implemented through the VMP-GEN-0001 Validation Master Plan.
Once an item of equipment has been decommissioned, the equipment file relating to it is sent to Iron Mountain for storage and retained as defined in MP-GEN-0002 Management of Documentation, Preparation and Control.
Each item of equipment is labelled with:

• 
  An asset number
  
• 
  A supplier label to indicate the instrument’s maintenance status. This label includes the date of last Preventative Maintenance and due date for next Preventative Maintenance.
  
• 
  A label to indicate the instrument’s calibration status. This includes the date of calibration and due date for recalibration.
  

The equipment asset number and all data relating to calibration/maintenance of the item of equipment are defined on LF-BT-0006 Biannual/Annual Maintenance Form and LF-BT-0005 As Required Maintenance Form, LF-HAEM-0005 Haematology Instrumentation Index, LP-BIO-0001 Operation and Maintenance of the Abbott Architect CI8200 Analyser and QF-MIC-0002 Microbiology Instrumentation Index details the equipment used in the Microbiology Department.

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5.3.1.3 Equipment Instructions for Use
Equipment may only be used by trained and authorised personnel. The operation and maintenance of each piece of equipment is detailed in the relevant standard operating procedure which is available at point of use. Standard Operating Procedures and/or user manuals define the safety precautions to be adhered to when using equipment.
In addition, current instructions on the use, safety and maintenance of equipment, including any relevant manuals and directions for use provided by the manufacturer of the equipment is readily available.
The laboratory has procedures for safe handling, transport, storage and use of equipment to prevent its contamination or deterioration.
5.3.1.4 Equipment Calibration and Metrological Traceability
The validation of all equipment, as described in VMP-GEN-0001 Validation Master Plan and procedures relating to the operation and maintenance of individual pieces of equipment, ensures that equipment is stored and used in ways that prevent its contamination or deterioration.
Any item of equipment that has to be calibrated by the Medical Scientist is detailed in the relevant SOP. A print out of all calibration/correction factors are maintained and are checked for correctness after each change is made.
This procedure includes:

1. 
   Taking into account conditions of use and the manufacturer’s instructions
   

2. 
   Recording the metrological traceability of the calibration standard and the traceable calibration of the item of equipment
   

3. 
   Verifying the required measurement accuracy and the functioning of the measuring system at defined intervals
   

4. 
   Recording the calibration status and date of recalibration
   

5. 
   Ensuring that, where calibration gives rise to a set of correction factors, the previous calibration factors are correctly updated
   

6. 
   Safeguards to prevent adjustments or tampering that might invalidate examination results
   

5.3.1.5 Equipment Maintenance and Repair
The Department of Pathology has a documented programme of preventive maintenance which, at a minimum, follows the manufacturer’s instructions and the details are recorded on LF-BT-0006 Biannual/Annual Maintenance Form, LF-HAEM-0005 Haematology Instrumentation Index, QF-MIC-0002 Microbiology Instrumentation Index details the equipment used in the Microbiology Department and in the case of the analyser in the Biochemistry records are stored in Q-Pulse.
Equipment is maintained in a safe working condition through regular maintenance and calibration. Equipment maintenance includes examination of electrical safety, emergency stop devices where they exist and the safe handling and disposal of chemical, radioactive and biological materials by authorized persons. At a minimum, manufacturer’s schedules or instructions, or both, are used.
When equipment is found to be defective, it is taken out of service, clearly labelled as out of order and appropriately stored until it has been repaired and shown by calibration, verification or testing to meet specified acceptance criteria. A MF-GEN-0051 Out of Service Equipment Form is completed. The laboratory examines the effect of any defects on previous examinations and institutes immediate action or corrective action. These records are filed in the individual Equipment File, as described in MP-GEN-0009 Procurement and Management of Equipment.
The majority of pieces of equipment are stationary, however equipment such as centrifuges which may be transported for repair or service are packaged and transported according to manufacturer’s instructions, with decontamination documented on MF-GEN-0037 Decontamination Declaration Form.
Where defective equipment is to be returned for service or repair, to be serviced or repaired onsite or to be decommissioned, the instrument is cleaned as appropriate and MF-GEN-0037 Decontamination Declaration Form is completed as described in MP-GEN-0009 Procurement and Management of Equipment. A copy of MF-GEN-0037 Decontamination Declaration Form is retained in the equipment file.
The service engineer is given the completed LF-GEN-0037 Decontamination Declaration Form on arrival, is provided with adequate space for performing repairs and is provided with a laboratory coat and disposable gloves, as required.
When equipment is removed from the direct control of the Department of Pathology to be serviced or repaired, or is serviced or repaired on-site, the Department ensures that the equipment is checked and shown to be functioning satisfactorily before being returned to use, as described in MP-GEN-0009 Procurement and Management of Equipment. This is done by carrying out quality control testing, or maintenance/validation checks appropriate to the instrument, as described in the standard operating procedure relevant to the piece of equipment.
5.3.1.6 Equipment Adverse Incident Reporting
Adverse incidents and accidents that can be attributed directly to specific equipment is investigated and reported to the manufacturer and appropriate authorities as required. Where equipment is found to be defective, the incident is reported as a non-conformance and the effect of the defect on previous examinations is investigated, as described in QP-GEN-0005 Control of Non-Conformances.

Equipment is labelled to indicate the status of calibration and maintenance and the dates that recalibration and maintenance are due.

5.3.1.7 Equipment Records
Records are maintained for each item of equipment that contributes to the performance of examinations. These equipment records includes, but not limited to the following:

1. 
   Identity of the Equipment
   

2. 
   Manufacturer’s Name, Model and Serial Number or other Unique Identification
   

3. 
   Contact Information for the Supplier or the Manufacturer
   

4. 
   Date of Receiving and Date of Entering into Service
   

5. 
   Location
   

6. 
   Condition when Received [e.g. new, used or reconditioned]
   

7. 
   Manufacturer’s Instructions
   

8. 
   Records that Confirmed the Equipment’s Initial Acceptability for Use when Equipment is Incorporated in the Laboratory
   

9. 
   Maintenance Carried Out and the Schedule for Preventive Maintenance
   

10. 
    Equipment Performance Records that Confirm the Equipment’s Ongoing Acceptability for Use
    

11. 
    Damage to, or Malfunction, Modification or Repair of the Equipment
    

These records are maintained and are readily available for the lifespan of the equipment and up to 30 years in storage.

Table 6 - Equipment Records outlines the records maintained for equipment and their location.

Table 6: Equipment Records

Record ID	Record Description	Record Location
a.	Identity of equipment	Asset Number label is located on each piece of equipment. LF-BT-0106 Instrument List for Blood Transfusion LF-HAEM-0005 Haematology Instrumentation Index and in the case of Biochemistry they are stored on Q-Pulse.
b.	Manufacturer’s name, equipment type, make, model and serial number.	Equipment Module in Q-Pulse and Equipment file
c.	Manufacturer’s contact person and telephone number.	Equipment file.
d.	Date of receipt and putting into service.	Equipment file.
e.	Current location.	LF-BT-0106 Instrument List for Blood Transfusion LF-HAEM-0005 Haematology Instrumentation Index and in the case of Biochemistry they are stored on Q-Pulse.
f.	Conditions when received e.g. new, used or reconditioned.	Equipment file.
g.	Manufacturer’s instructions/ manual	Equipment file or at the point of use whichever is appropriate.
h.	Equipment performance records	Validation of Equipment – Equipment file Calibration of Equipment – Equipment file
i.	Maintenance carried out and planned for the future	Preventative Maintenance of Equipment – Equipment file Future calibration and maintenance plan in LF-BT-0006 Biannual/Annual Maintenance Form LF-HAEM-0005 Haematology Instrumentation Index and in the case of Biochemistry they are stored on Q-Pulse
j.	Damage, malfunction, modification and repair	Equipment file.
k.	Predicted replacement date	Replacement date requirements for Equipment are identified in the LF-BT-0005 As Required Maintenance Form. Expiry dates of reagents and products are indicated on the label of the product.

It is the responsibility of the Quality Co-ordinator and the Acting Chief Medical Scientist to ensure that all the relevant documentation is obtained and maintained for each piece of equipment.

It is also the responsibility of the Quality Co-ordinator and Acting Chief Medical Scientist to ensure that validation, calibration and maintenance are kept up to date and carried out in accordance with the relevant plan. This activity is aided through the use of LF-BT-0006 Biannual/Annual Maintenance Form, LF-HAEM-0005 Haematology Instrumentation Index, QF-MIC-0002 Microbiology Instrumentation Index details the equipment used in the Microbiology Department and in the case of Biochemistry they are stored on Q-Pulse

5.3.2 Reagents and Consumables

1. 
   General
   

• 
  The Department of Pathology has documented procedures for the reception, storage, acceptance testing and inventory management of reagents and consumables. All reagents and consumables undergo Quality Assurance testing prior to use in examinations. This is implemented through the procedure for batch acceptance of reagents MP-GEN-0013 Management of Materials. LP-HAEM-0012 Batch Acceptance of Reagents in Haematology, LP-BIO-0007Batch Acceptance of Reagents, Calibrators, Q.C. and Consumables and LP-MIC-0065 Batch Acceptance in Microbiology.
  

2. 
   Reagents and Consumables – Reception and Storage
   

The laboratory is the sole receiving facility for reagents and consumables and it has adequate storage and handling capabilities to maintain purchased items in a manner that prevents damage or deterioration.

The laboratory stores received reagents and consumables according to the manufacturer’s specifications.

3. 
   Reagents and Consumables – Acceptance Testing
   

Each new formulation of examination kits with changes in reagents or procedure, or a new lot or shipment is verified for performance before use in examinations as per MP-GEN-0013 Management of Materials.

Consumables that can affect the quality of examinations are verified for performance before use in examinations.

4. 
   Reagents and Consumables – Inventory Management
   

The laboratory has inventory control systems for reagents and consumables.

The systems for inventory control segregate uninspected and unacceptable reagents and consumables from those that have been accepted for use as per MP-GEN-0013 Management of Materials.

5. 
   Reagents and Consumables – Instructions for Use
   

Instructions for the use of reagents and consumables, including those provided by the manufacturers are available to staff as required.

5.3.2.6 Reagents and Consumables – Adverse Incident Reporting
Adverse incidents and accidents that can be attributed directly to specific reagents or consumables are investigated and reported to the manufacturer and appropriate authorities, as required in accordance with QP-GEN-0008 Complaints Procedure.
5.3.2.7 Reagents and Consumables – Records
Records are maintained for each reagent and consumable that contributes to the performance of examinations as per LP-BT-0002 Monitoring of Materials in Blood Transfusion, LP-HAEM-0012 Batch Acceptance of Reagents in Haematology, LP-BIO-0007 Batch Acceptance of Reagents, Calibrators, Q.C. and Consumables and LP-MIC-0065 Batch Acceptance in Microbiology.

These records include but not limited to the following:

1. 
   Identity of the reagent or consumable
   

2. 
   Manufacturer’s name and batch code or lot number
   

3. 
   Contact information for the supplier or the manufacturer
   

4. 
   Date of receiving, the expiry date, date of entering into service and, where applicable, the date the material was taken out of service
   

5. 
   Condition when received [e.g. acceptable or damaged]
   

6. 
   Manufacturer’s instructions
   

7. 
   Records that confirmed the reagent’s or consumable’s initial acceptance for use
   

8. 
   Performance records that confirm the reagent’s or consumable’s on-going acceptance for use are logged on the Internal Quality Control Logs in each department
   

Where the laboratory uses reagents prepared in-house, the records includes, in addition to the relevant information above, reference to the person or persons undertaking their preparation and the date of preparation.