HTS LabsQuality Assurance
Precision Diagnostics for Better Patient Outcomes
HTS LabsQuality Assurance
At HTS Labs, quality is at the core of everything we do. Our commitment to delivering precise, reliable, and timely diagnostics is underpinned by internationally recognized certifications, ensuring that our services meet the highest standards in healthcare diagnostics and data security.
ISO 15189 Accreditation
Our laboratories are accredited to ISO 15189, which sets the global benchmark for quality and competence in medical laboratories. This certification ensures that all aspects of our diagnostic services, from sample handling to final reporting, adhere to strict quality controls. By maintaining ISO 15189 accreditation, we guarantee that our clients receive the highest standard of diagnostic accuracy and reliability.
ISO 27001 Certification
Data security and patient confidentiality are paramount at HTS Labs. Our ISO 27001 certification demonstrates our rigorous approach to information security management. This certification ensures that we maintain robust systems to protect sensitive patient data, complying with GDPR and industry best practices. By achieving ISO 27001, we safeguard the integrity, confidentiality, and availability of all patient information.
ISO 9001 Quality Management
HTS Labs is proud to have achieved ISO 9001 accreditation, demonstrating our dedication to continuous improvement and operational excellence. This internationally recognised standard reflects our commitment to maintaining an efficient quality management system, delivering exceptional services, and ensuring the highest levels of customer satisfaction.
Pathology & Quality Governance Board
At HTS Labs, our Pathology & Quality Governance Board plays a crucial role in ensuring that our diagnostic services remain at the forefront of medical innovation and excellence. Comprising experienced medical professionals and industry leaders, our Clinical Advisory Board provides expert guidance on clinical best practices, regulatory compliance, and the integration of emerging technologies in pathology and diagnostics.
By collaborating closely with our advisory board, HTS Labs ensures that our services are not only scientifically sound but also aligned with the latest advancements in healthcare. Their insights help us maintain the highest standards of accuracy, reliability, and patient safety, while continuously improving the quality of care we provide to healthcare providers and their patients.
Patrick Clarke
CEO
Patrick is the CEO of HTS Labs, bringing over 20 years of experience in the medical and private pathology testing field. He holds a BSc. Hons in Science from Maynooth University. Before joining HTS Labs, Patrick served as Commercial Manager at MedLab Pathology, overseeing Sales, Customer Support, IT, and Logistics, and significantly growing the company’s revenue. He has also held operational roles at Eurofins and Biofact Pharma, contributing to business expansion in diagnostic laboratories. His career has focused on streamlining operations and driving growth across various healthcare and laboratory service sectors.
Cathal Farrell
Scientific Advisor
Cathal Farrell is a CORU Medical Scientist, a Fellow of the Academy of Clinical Science and Laboratory Medicine (ACSLM) and has recently completed his MBA from Dublin City University. He also serves as a member of the national Cellular Pathology Advisory Board with the ACSLM. Cathal has a BSc in Biomedical Science from DIT, an MSc in Healthcare Ethics and Law from RCSI, and is due to complete an MBA from DCU this year. He also trained in the London Regional Cytology Training Centre to attain competency in reading cervical cytology smears. Cathal is experienced in leading histopathology labs and in enabling them to achieve either ISO15189, or CAP accreditation.
Dr. Máire Lavelle
Medical Advisor
Dr. Máire Lavelle LRCP & SI MB BCh NUI FRCPath FFPath (RCPI) FRCPI is a Consultant Histopathologist and Lead Breast Histopathologist at University Hospital Limerick. A graduate of the Royal College of Surgeons in Ireland (2004), she completed specialist training in Histopathology in 2016. Dr. Lavelle has expertise in Breast Histopathology, including symptomatic and screening services, and is actively involved in education, training, and research. She is a Fellow of the Royal College of Pathologists and the Royal College of Physicians of Ireland and collaborates with the University of Limerick on AI and breast tissue biobanking. Dr. Lavelle also serves on national accreditation and pathology advisory groups.
Sinead Connolly
Quality Advisor
Sinead brings over 25 years of expertise in quality management and regulatory compliance. She has extensive experience working with ISO15189, ISO17025, and CAP standards, as well as EU Directives and Irish Statutory Instruments. Her work spans regulatory frameworks for tissues and cells, blood and blood products, and solid organs. Sinead’s deep knowledge of accreditation and compliance ensures operational excellence in healthcare and laboratory settings. She continues to provide guidance and oversight in these critical areas, contributing to the delivery of high-quality and compliant medical and scientific services.
