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Genova Diagnostics Quality Control Letter

Please NOTE: If your GP or endocrinologists refuses to acknowledge Genova Diagnostic’s Test Results, please copy out the Genova Diagnostics Quality Assurance to show them

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Genova Diagnositcs aim to maintain the highest quality of testing available. To this end, we follow a Quality Assurance Program that details activities and programs focused on ensuring the continuing high quality of test results. The following procedures are in place to assess all aspects of the laboratory including assessment of individual analytes, equipment, and staffing competency to ensure high standards are maintained.

Pre-analytical, analytical and post-analytical aspects of laboratory testing are evaluated through the QA program. The Office of Quality conduct a monthly Quality Probe initiative providing an evaluation of all three of these analytical aspects. This probe reviews the entire laboratory process from kit order/sample collection through result reporting and billing for a different product offering each month. The results of the monthly Quality Probes are reviewed by the Laboratory Director and evaluated for opportunities for improvement.

Proficiency testing is also a part of the quality assurance program, where we compare our test results with those of other laboratories. Proficiency challenges allow comparison of results for each analyte and afford the opportunity for peer comparison. There are over 5,500 individual proficiency challenges covered in over 100 separate events from 11 different providers performed by the laboratory annually. These challenges are reviewed by the laboratory administrative team and evaluated for trends or performance issues. Proficiency testing is one of the laboratory metrics monitored monthly for each analyte in each laboratory section. The most common independent EQA (external quality assurance schemes) Genova Diagnostics take part in the UK are NEQAS (National External Quality Assessment scheme), IMMQAS (Immunology Quality Assurance Assessments), and IBL International.

Laboratory staff competency and training is an integral part of quality laboratory testing. The competency of each laboratory staff member is evaluated every six months. In addition, members of the laboratory team are required to attend 8 hours of continuing education annually, 4 hours of which must be related to the technical performance of their job. Documentation of competency testing and training is another of the laboratory metrics evaluated monthly.

Genova Diagnostics Europe also has a QA system for documenting issues either customer or laboratory originated. This system affords the opportunity for review and documentation of remedial action or clarification. A report is compiled monthly and reviewed by management.

Evaluation of reported test results and assay procedures is crucial to ensuring quality in laboratory testing. Each laboratory assay procedure is reviewed annually by the laboratory section supervisor and the laboratory director. It is evaluated for accuracy and inclusion of pertinent updates.

Technical performance of each individual assay is reviewed monthly through review of quality control performance. IQC (Internal Quality Controls) are included with each batch of patient samples every time a test procedure is performed. A minimum of 2 levels of quality control is required for each analyte. Analytes requiring extensive pre-analytical processing generally include 2 additional process controls. The data from the quality controls is documented and evaluated prior to reporting of patient results, all IQC must pass before results are released. Approximately 1,140 quality control charts are reviewed monthly by the Scientific Director, Laboratory Director, Laboratory Operations Manager, Laboratory Manager and technical supervisors. These Levy-Jennings charts facilitate the evaluation of a particular assays performance over time. In addition, the applicability of established reference ranges for each assay procedure is confirmed annually through patient data review.

As part of the requirements for federal laboratory licensure and State of New York laboratory permit in the US, the laboratory undergoes scheduled inspections by the State of New York and the Centers for Medicaid and Medicare Services. These inspections are conducted by trained laboratory professionals and generally take several days to complete. Every aspect of laboratory operation is evaluated during these inspections including but not limited to: staff competency, assay validation and performance, result reporting and reference range applicability, and quality assurance initiatives. These inspections occur every two years, however, regulatory inspection readiness must be maintained at all times.

Together these quality initiatives ensure the delivery of a quality laboratory product to the customer.

Laboratory Licensure and Permits

The laboratory is licensed and accredited by the Centers for Medicaid and Medicare Services. Appropriate individual state permits are also maintained for the following states: New York, Maryland, Pennsylvania, Rhode Island, and Florida. Permit applications have been submitted to New Jersey and California. CPA is being worked towards in the UK.

Nigel Abraham, PhD, FIBMS is the Scientific Director. He is a graduate in haematology from St Georges Medical School London and went on to gain an MSc from the University of Surrey and later completed his PhD in Immunology. He is a fellow of the IBMS and a Chartered Scientist. His primary focus is research and development and delivery of Genova Diagnostics Europes Health Education program.

Eloise Britten BSc (Hons) MIBMS is the Laboratory Manager. She holds a Bachelor of Science in biomedical Science and is a member of the IBMS. She specializes in microbiology, parasitology and gynaecological pathology. She is currently completing her MSc in Clinical Nutrition with Immunology.

Amy L. Peace-Brewer, PhD, (D) ABMLI is the laboratory director. She is a board certified immunologist and has Certificate of Qualifications from the State of New York for the following areas: Diagnostic Immunology; Bacteriology; Clinical Chemistry; Endocrinology; Hematology (limited to fibrinogen and fecal lactoferrin) Mycobacteriology; Parasitology; Virology.

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