January 22, 2017

ACCREDITATIONS

Accreditation Status
 UKAS ISO 15189:2012. Offered ISO 15189:2012.
 Care Quality Commission  Registered to carry out the following activities: Diagnostic and Screening Processes , June 2017

Participant ID: 1-3839766903

Registered Manager: Mr Christopher Evagora

Responsible Individual: Mr Christopher Evagora

 NHS Digital (was Health and Social Care Information Centre)  Caldicott Guardian: Mr Christopher Evagora (8JP97); chris@pathognomics.com

Information Governance Lead: Mr Alec Hirst

IG Tool Kit Assessment:  21/09/2017 ; Version 14.1 (2017-2018), Score 66%Self Assessed Grade: Satisfactory . Reviewed Grade: Satisfactory

 Information Commissions Office  Registration Number: ZA224395
Health & Care Professions Council (HCPC) All biomedical scientists working in the department are registered

  • Christopher Evagora; BS48390
General Medical Council All reporting consultants are GMC registered and monitored on a yearly basis.
External Assurance Schemes
  • UKNEQAS Cellular Pathology (General)
  • UKNEQAS IHC (General)
  • Thermo Fisher QRS (processing)

General Information

What is Accreditation?

Accreditation is the formal recognition that an organisation is competent to perform specific processes, activities, or tasks (which are detailed in a scope of accreditation) in a reliable credible and accurate manner.  The provision of accreditation must:

  • be objective, transparent and effective;
  • use highly professional competent assessors and technical experts in all relevant fields;
  • use assessors (and subcontractors) that are reliable, ethical and competent in both accreditation processes and the relevant technical fields.

Accreditation delivers confidence in certificates and conformity statements. It underpins the quality of results by ensuring their traceability, comparability and validity.

 

Who is United Kingdom Accreditation Service (UKAS)?

The United Kingdom Accreditation Service is the sole national accreditation body recognised by the British government to assess the competence of organisations that provide certification, testing, inspection and calibration services. It evaluates these conformity assessment bodies and then accredits them where they are found to meet the internationally specified standard.

 

Medical Laboratory accreditation (ISO 15189)

UKAS provides accreditation to the internationally recognised standard ISO 15189:2012 Medical Laboratories – requirements for quality and competence.

UKAS ISO 15189 accreditation covers the following disciplines:

  • Clinical Biochemistry – Toxicology – Endocrinology
  • Haematology – Blood Transfusion
  • Microbiology – Virology – Parasitology – Serology – Mycology
  • Histopathology – Cytology – Mortuaries
  • Immunology
  • Genetics
  • Andrology

 

Health & Care Professions Council (HCPC)

They are a regulatory body who were set up to protect the public interests. They do this by constructing a registry of health and care professionals who meet certain standards in training, professional skills, behaviour and health relating to their roles.They regulate the following professions;

  • Arts therapists
  • Biomedical scientists
  • Chiropodists / podiatrists
  • Clinical scientists
  • Dietitians
  • Hearing aid dispensers
  • Occupational therapists
  • Operating department practitioners
  • Orthoptists, paramedics
  • Physiotherapists
  • Practitioner psychologists
  • Prosthetists / orthotists
  • Radiographers
  • Social workers in England
  • Speech and language therapists

 

General Medical Council (GMC)
The GMC is a public body that maintains the official register of medical practitioners within the United Kingdom. Its chief responsibility is ‘to protect, promote and maintain the health and safety of the public’ by controlling entry to the register, and suspending or removing members when necessary. It also sets the standards for medical schools in the UK. Membership of the register confers substantial privileges under Part VI of the Medical Act 1983. It is a criminal offence to make a false claim of membership.

 

Good Clinical Practice (GCP)

GCP is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights.