1. Laboratory equipment Dr. W. Huisman Cairo, November 21th 2012

2. 5.3 Laboratory equipment In third edition somewhat revised: 5.3 Laboratory equipment, reagents and consumables I will follow third edition because it is somewhat clearer. No essential differences compared to valid second edition

3. Laboratory equipment (general) Requirements for selection connected to required performance Adequate function after installation and validation of this function Standard Operating Procedure Record of its function-which aspects are important Operation by competent personell How to handle defective incidents Computing system- see laboratory information system

4. Laboratory equipment in relation with external service supplies Policies for selection of equipment Record of supplier Policies of placing into service (validation) Inventory of supplies Chapter 5.3 strongly connected to 4.6 (2 e edition)

5. Laboratory equipment in relation with LIS Annex B Laboratory Information system (LIS) Not just an annex, essentials also a requirement of 5.3.11 (2 e edition) and part of standard in edition 3 Protection of data Validation of software Access (confidentiality) Backup

6. 5.3.1 Equipment 5.3.1.1 General Procedure and documentation for selection, purchasing and management Laboratory shall be furnished with all equipment needed Laboratory shall replace equipment as needed to ensure quality 5.3.1.2 Equipment acceptance testing Before use verify that equipment is capable to comply with requirements Installation validation by manufacturer Operational validation by laboratory and/or manufacturer Each item shall be uniquely labelled

7. 5.3.1 Equipment 5.3.1.3 Equipment- Instruction for use Equipment shall de operated at all times by trained and authorized personnel (records of training and competence) Instructions for use, safety, maintenance including manuals and directions for use Laboratory shall have procedures for safe handling, transport, storage and use of equipment to prevent contamination or detoriation

8. 5.3.1 Equipment 5.3.1.4 Equipment calibration and metrological traceability Documented procedures for calibration Manufacturer’s instructions Records of metrological traceability to a reference material or reference procedure ( if possible traceable to the highest order, demands can differ between accreditation bodies, and also responsibility for the manufacturer) Records of calibration status and date of calibration If correction factors needed calibration updated Safeguard to prevent adjustments

9. 5.3.1 Equipment 5.3.1.4 Calibration and traceability When impossible or irrelevant other means for providing confidence shall be applied Use of certified reference material Examination or calibration by another procedure Mutual consent standards or methods Important role of professional organisations Joint Commission on Traceability in Laboratory Medicine Providers of External Quality Control Materials Role of professionals

10. 5.3.1 Equipment 5.3.1.3 Traceability Real problem for users that our results are different between laboratories (and sometimes even within laboratories when using different instruments) Patients move often between laboratories This indicates need to inform the users about used methodology and sometimes need to make it quite clear in the reports. Especially related to tumour markers

11. 5.3.1 Laboratory Equipment 5.3.1.5 Equipment maintenance and repair Documented programme of preventive maintenance When defective: taken out of order and labelled. Take care it is not used Examine effect of defects on previous examinations and start immediate action and/or corrective action After repaired or moved: control funcioning Decontaminate before repair 5.3.1.6 Equipment adverse incident reporting Shall be investigated and reported to manufacturer and appropriate authorities

12. 5.3.1 Equipment 5.3.1.7 Equipment records Records shall be maintained for each item of equipment that contributes to its performance Records shall include Identity, manufacturer’s name, model serial number, contact information, date of receiveing and date entering in operation, location, condition when received, manufacturer’s instructions,installation and operational validation records, maintenance schedule en its records, performance records, damage,malfunctioning, repair and modification

13. 5.3.2 Reagents and consumables 5.3.2.1 General Documented procedures for reception, storage acceptance testing and inventory management 5.3.2.2 Reception and storage Laboratory shall store according manufacturer’s instructions If received elswhere laboratory shall verify their competence 5.3.2.3 Acceptance testing Verify each change including new lot before use 5.3.2.4 Inventory management Inventory control system established Separation between inspected and uninspected reagents and consumables

14. 5.3.2 Reagants and consumables 5.3.2.5 Instructions for use Instructions for use shall be readily available 5.3.2.6 Adverse incident reporting Shall be investigated and reported to manufacturer and appropriate authorithies 5.3.2.7 Records Records maintained for each reagent and consumable that contributes to performance. These include: Identity, name manufacturer and batch code, contact information, date of receive,expiry, putting into service, condition when received, manufacturer’s instructions, records for initial acceptance (validation), performance records For in house methods reference to persons related to preparation

15. 4.6 External services and supplies Laboratory shall have documented procedure for selection and purchasing Laboratory shall select and approve supplier based on requirements A list of selected and approved suppliers shall be maintained Purchasing information shall describe the requirements Laboratory shall monitor performance of supplier

16. 5.10 Laboratory Information Management (3 e edition) 5.10.1 General Access to data needed to provide service Procedure for confidentiality of patient information 5.10.2 Authorities and responsibilities Authority and responsibility shall be defined, including maintenance and modifications Authority and responsibility defined of all personell who use the system regarding: Access patient data, entering patient data and examination results, change patient data or examination results, authorize the release of examination results and reports

17. 5.10 Laboratory Information Management 5.10.3 Information system management System used for collection, processing, recording, reporting, storage or retrieval of examination data shall be Validated by supplier and verified by laboratory before use, and after any changes Documented and documents available Protected from anauthorized use Safeguarded Environment according manufacturer’s instructions Integrity of data secured Data protection

18. 5.10 Laboratory information management 5.10.3 Information system management Laboratory shall verify that the results of examination are accurately reproduced, and available to the intended receiver of information Laboratory shall have documented contingency plan to maintain services in the event of downtime or failure When contracted outside laboratory management responsible that all requirements are fulfilled