Laboratory User Handbook (Property of The Scientists Laboratory Ltd. Laboratory User handbook TSL-GEN-MP003 Version1.1, Effective from: March 2021 Author: Niru Banduvula, Approver: Dr Peter Timms). The Scientists Laboratory Ltd (TSL) is a limited company registered in England and Wales. Company Registration No. 11539757; Registered office address: Unit 16 Bourne Court, Southend Road, Woodford Green, London - IG8 8HD. Page 1 of 32 DOCUMENT REVIEW HISTORY The review history to this document is recorded here. Version Review Action Description Page no. Reviewed by No. Date Inclusion of Consultant Microbiologist/ 6 Niru 1.1 Inclusion 1 Mar 2021 Virologist to the user manual Banduvula 1.1 Inclusion Specimen and request form labelling 13 Niru 1 Mar 2021 criteria for TEST TO RELEASE specimens Banduvula 1.1 Inclusion Self-swabbing instructions as Appendix 1 28 Niru 1 Mar 2021 Banduvula Version Approved by: (Dr Peter Timms) (Property of The Scientists Laboratory Ltd. Laboratory User handbook TSL-GEN-MP003 Version1.1, Effective from: March 2021 Author: Niru Banduvula, Approver: Dr Peter Timms). The Scientists Laboratory Ltd (TSL) is a limited company registered in England and Wales. Company Registration No. 11539757; Registered office address: Unit 16 Bourne Court, Southend Road, Woodford Green, London - IG8 8HD. Page 2 of 32 I. Table of Contents II. About the Laboratory ............................................................................................................................ 4 III. Laboratory Policy.............................................................................................................................. 5 IV. About this Handbook ........................................................................................................................ 5 V. Laboratory location, opening hours & Key contacts. .......................................................................... 5 A. Location of the laboratory ................................................................................................................ 5 B. Opening times ................................................................................................................................... 6 C. Staff / Key Contacts .......................................................................................................................... 6 D. Contact information: ......................................................................................................................... 7 VI. Laboratory services information ..................................................................................................... 7 A. Guidance on Collection, handling & transportation of specimens ................................................ 7 1. Transportation of specimens ....................................................................................................... 7 2. Packaging requirements .............................................................................................................. 8 3. Specimen Collection & handling ................................................................................................10 B. Requesting tests ..............................................................................................................................13 1. Specimen and request form labelling criteria ..........................................................................13 2. Specimen and request form labelling for SARS COV2 (Covid-19) TEST TO RELEASE ..........14 3. Laboratory criteria for accepting / rejecting specimens .........................................................15 C. Test repertoire ................................................................................................................................16 1. Referral of work: .........................................................................................................................16 2. Turnaround times: .....................................................................................................................16 3. Abbreviations used in test table: ...............................................................................................16 4. Test index: ...................................................................................................................................17 D. Factors affecting the assays: ..........................................................................................................27 E. Reference values: ............................................................................................................................27 F. Patient confidentiality & Data protection: ....................................................................................27 G. Additional Services: ........................................................................................................................27 H. Quality Assurance: ..........................................................................................................................27 I. Accreditations: ................................................................................................................................27 J. Results & reports: ...........................................................................................................................28 K. User feedback & complaints procedure: .......................................................................................28 L. Pricing: .............................................................................................................................................28 M. Payment for Services: .....................................................................................................................29 VII. Appendix 1 – Self-swabbing Instructions for COVID-19 (TSL-POS-001a) .........................................30 (Property of The Scientists Laboratory Ltd. Laboratory User handbook TSL-GEN-MP003 Version1.1, Effective from: March 2021 Author: Niru Banduvula, Approver: Dr Peter Timms). The Scientists Laboratory Ltd (TSL) is a limited company registered in England and Wales. Company Registration No. 11539757; Registered office address: Unit 16 Bourne Court, Southend Road, Woodford Green, London - IG8 8HD. Page 3 of 32 II. About the Laboratory The Scientists Laboratory Ltd (TSL) is a private blood testing/ diagnostic health check laboratory founded by a team of Biomedical Scientists with a passion for improving health and wellbeing through innovation. Laboratory provides service to private General practitioners, Urgent treatment centres (UTC), Occupational health screening, remote medical service companies, direct public and other private health companies running preventative health services in the UK. The main objectives of The Scientists Laboratory are: o To enable people to manage their overall health & wellbeing in a proactive manner by showing the impact of their lifestyle on their overall health and help them manage chronic medical conditions through regular blood testing. o Provide discreet postal blood testing service that is convenient, timely, easy to use and insightful. o To provide highly efficient and quality diagnostic service and reduce healthcare burden on current systems. o To add value to the local clinics and primary care service providers through their specialist knowledge and exceptional team ethics. o To maintain lasting relationships with customers based on mutual respect, trust, care, and open mindset. o To provide results with in 4hrs for urgent referrals and 24hrs for non-urgent specimens. o To use advanced and secure cloud-based API (Application program interface) technology-based platforms to provide seamless results transfer. The Laboratory provides a comprehensive analytical, advisory services to its users. Staff employed in laboratory provide the vital scientific expertise to aid its customers (Clinicians and other health care professionals) in the interpretation of laboratory investigations, in addition there is a major role in supporting research and development, teaching & training. The Laboratory has a test repertoire which comprises all commonly requested tests of Biochemistry and Haematology. Any tests requested outside the repertoire are referred to external labs. Due to the current Covid-19 pandemic, the laboratory has expanded its services to testing of SARS-COV-2 (Both RT-PCR & antibody) to cater for a variety of clientele from private GPs/clinicians, travel industry and film/media productions. The laboratory is currently registered with UKAS (registration number 21132) and working towards accreditation to ISO15189:2012; laboratory participates in all appropriate external (Property of The Scientists Laboratory Ltd. Laboratory User handbook TSL-GEN-MP003 Version1.1, Effective from: March 2021 Author: Niru Banduvula, Approver: Dr Peter Timms). The Scientists Laboratory Ltd (TSL) is a limited company registered in England and Wales. Company Registration No. 11539757; Registered office address: Unit 16 Bourne Court, Southend Road, Woodford Green, London - IG8 8HD. Page 4 of 32 quality assurance schemes to ensure that the quality of results produced by the laboratory is on par with and comparable to other UK laboratories. III. Laboratory Policy The Scientists laboratory team ensure that the laboratory functions to the highest clinical & administrative criteria and for Quality & compliance, follows International ISO15189:2012 medical laboratory