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Page 36
Biochemistry & Molecular Biology Journal
ISSN: 2471-8084
Internat i ona l Conference on
Biotechnology, Biomarkers
& Systems Biology
M a r c h 0 4 - 0 5 , 2 0 1 9
Am s t e r d a m , N e t h e r l a n d s
Biotechnology, Biomarkers & Systems Biology 2019
The NHS will be a world-leading healthcare organization to predict and diagnose inherited and acquired disease, and to personalize
treatment and intervention. This program was designed to validate and quality manage the introduction of Blood Coagulum-
OMICS and verify genomic, viscoelastic, and proteomic predictive value for hemostasis and thrombosis.
Background:
In 2014, a Patient Blood Management program was overseen by a national governance representative, sponsored by
an anesthetic lead and edited by an MHRA inspector who stated “this program is suitable for the NHS”. In 2017, that program was
posted to the hemostasis and thrombosis, National External Quality Assurance Scheme and then to the British Blood Transfusion
Society, in the UK.
Study:
The conclusion read as “scientific specialists are now firmly planted in the realms of clinical effectiveness, interfacing
clinicians on the governance board. We must now accelerate the PBM Quality Assurance network to control risk from genomic
and proteomic explosions in personalized medicine. Quality assures our technological advances from end to end of the surgical
examination phase and control our pharmacological breakthroughs in support of healthcare clinicians.
Program Development:
On the 4th of July 2017, Professor Dame Sally, the Chief Medical Officer of the UK called on the NHS to
provide access to genomic sequencing, as standard. This followed studies that realised genome models to pre-empt a bleed
or thrombotic event. Meanwhile coagulation and fibrinolysis elasticity reference ranges to monitor a clinical event or target a
therapy are developing, at a time when coagulation proteomics have passed proof of concept.
Conclusion:
This second program on Blood Coagulum-OMICS was designed to stop the bleed and thrombotic event by improving
the predictive value in pre-examination and examination phases. A program for Blood Coagulum-OMICS is a minimum standard
for haemostasis and thrombosis and requires consideration by the International Organisation for Standardisation.
Biography
James Henry completed his Master of Science (Upper Merit)
in 2009 from Middlesex University U.Kin Molecular Pathology.
Also he completed his Master of Science (Distinct) in 2014
fromUniversity of Greenwich U.K in Patient Blood Management
Quality Systems. In 2014 a Patient BloodManagement program
was overseen by a U.K national governance representative,
sponsored by an anesthetic lead and edited by an MHRA
inspector who stated “this program is suitable for the NHS”. In
2017 that program was posted to the National External Quality
Assurance Scheme and then to the British Blood Transfusion
Society. In 2018, ISO published the “Quality of an organization —
Guidance to achieve sustained success”. The author of “Blood
Coagulum-OMICs” has developed a model for hemostasis and
thrombosis genomic pre-exams and a viscoelastic & proteomic
examination to improve predictive value in personalized and
regeneration medicine
.
jameshenrybms@hotmail.comA model and guide for Blood coagulum-OMICS
James Andrew Henry
Atlantis BMS Limited, UK
James Andrew Henry, Biochem Mol biol J 2019, Volume:5
DOI: 10.21767/2471-8084-C1-023
ISO. STD
REVISED
INTERNATIONAL ORGANISATION FOR STANDARDISATION: TITLE
10005
2005 QMS – Guidelines for Quality Plans
14155
2011 Clinical Investigation of Medical Devices for Human Subjects – GCP *
15189
2012 Medical Laboratories – Requirements for Quality and Competence
27001
2013 Information Security Management Systems - Requirements
13485
2016 Medical Devices – QMS – Requirements for Regulatory Purposes
31010
2009 Risk Management – Risk Assessment Techniques
18113
2009 Specific Requirements for Info. Supplied by the Manufacturer of IVD reagents
14791
2012 Risk Management for Medical Devices
22870
2016 Point of Care Testing (POCT) – Requirements for Quality and Competence
17043
2010 Conformity Assessment – General Requirements for Proficiency Testing
9000
2015 QMS – Fundamentals and Vocabulary
90011
2011 Guidelines for Auditing Management Systems
17011
2017 Conformity Assessment General Requirements for Accrediting Conformity
*Excludes IVD Medical Devices [This excludes viscoelasticity. An application to spectral
proteomics is unknown]
Table 1. List of ISO standards in a Blood Coagulum-OMICS program