SSLC can assist you through the regulatory process - to start up a COVID-19 testing laboratory or to add COVID-19 testing to your menu. We have worked successfully with universities, biotechnology companies, and independent clinical labs.
"SSLC, Joanne, Liz, and Glenn, were a pleasure to work with, knowledgeable in all parts of the process, and provided the documents and guidance necessary to achieve our certification. They were also great teachers for me during the process. From start to finish we were licensed and CLIA certified in approximately 8 weeks and there is no way we could have done this without the help and guidance of the SSLC team. I highly recommend their services to one and all." - Northeastern University Professor Jared Auclair
From our President and Founder...
Since 1988, South Shore Laboratory Consultants has provided clinical laboratory consulting services to laboratories seeking CLIA or CAP certification, MA and other state licensures. We have the expertise to facilitate all needs, from initial laboratory start-up through complete licensure, while ensuring continuous maintenance of your regulatory and quality systems. South Shore Laboratory Consultants has a 100% success rate for maintaining compliance with both CLIA, CAP and state regulations in our affiliated laboratories. We pride ourselves for working in a hands-on, friendly manner with the ability to interact successfully at both the laboratory and administrative levels.
Joanne B. Lannon, M.Ed., DLM(ASCP)
South Shore Laboratory Consultants, Inc.
Running a lab is complicated, demanding, and ever-evolving. We do our job so that you can do yours. We’ll make sure your lab operates in compliance with federal accreditation (CLIA), state licensures (MA, NY, CA, MD, PA, RI), as well as other accrediting agencies (CAP, The Joint Commission, A2LA:ISO 15189). That way, you can focus on what you do best - directing a high-performance laboratory while we handle the regulations.
We have decades of experience with independent labs that perform CLIA moderate and high complexity laboratory developed tests (LDTs) as well as those performing clinical trial tests. Our current and past clients include biotechnology, biopharmaceutical, and diagnostic testing companies.
In addition, we offer Point of Care Testing (POCT) auditing. POCT auditing is available for physician office labs and large multi-site hospital systems to ensure regulatory compliance and the highest quality of patient care. SSLC provides a comprehensive audit report with their findings and actionable recommendations to achieve continual regulatory readiness. We utilize CLIA, CAP, MA state and the Joint Commission guidelines to conduct our comprehensive audit.
Our expertise has grown with the technology in labs and we can help you specifically with your genetic testing, including Sanger and Next-Generation Sequencing.
As part of our ongoing support, we provide Quality Assurance Reviews throughout the year which are comprehensive audits of all required pre-analytic, analytic, and post-analytic laboratory operations using fixed quality monitors.
Our QA Reviews also ensure that the quality of your key systems such as QA, QC, Proficiency Testing, Equipment Maintenance, and Training/Competency records are always maintained at the highest level.
After the reports, we’ll be there for any corrective and preventative actions that may arise, including assistance with required Procedure Manual documentation: MA/CLIA /CAP/NY - compliant policy and procedural templates are provided. Let us know what you need and we can start working together today.
Whether you are interested in start-up services through completion of CLIA and Massachusetts state licensure, on-going oversight of your lab or consulting for special projects related to your laboratory, South Shore Laboratory Consultants is available to address your needs.
Joanne Lannon, President and Founder of South Shore Laboratory Consultants, has over 25 years of experience in laboratory medicine, and has provided consulting services to many types of clinical laboratories since 1988.
As one of the first laboratory consultants in the state of Massachusetts, she has used her vast experience to maintain an exceptional reputation within the industry. Joanne is always highly recommended by professionals in her field.
She has a Masters Degree in Education and is certified by the American Society of Clinical Pathologists as a Diplomate in Laboratory Management.
Director of Quality Assurance for South Shore Laboratory Consultants since 1993, Kathy Oates has worked in laboratory medicine for over 25 years.
Her past employment includes Supervisor of the Clinical Laboratory Program at the Massachusetts Department of Public Health.
Kathy is highly respected by her peers and well known by professionals throughout the industry. She is a Medical Technologist certified by the American Board of Clinical Pathologists and holds a Masters of Public Health from Boston University.
Glenn Bouchie is an ASCP Board registered Medical Technologist.
He has functioned as a Laboratory Manager, Senior Research Scientist, Principle Investigator, CAP Inspector, and Technical Supervisor with over 25 years of experience in method research and development, regulatory compliance, laboratory operations management, quality assurance, and process improvement in Research, Hospital, Clinical Diagnostic, Drug Development, and Life Sciences settings.
Elizabeth Mullady is an ASCP Board registered Medical Laboratory Scientist with a Masters degree in Health Care Administration. She has 15 years of experience in clinical laboratories, first as a technologist in the Infection Disease Diagnostic lab at Boston Children’s Hospital and then in the quality assurance and regulatory affairs field in a molecular genetics lab.
In her role as Director of Quality Assurance and Regulatory Affairs she was responsible to maintain the lab in a constant state of regulatory readiness while keeping the wheel of continual process improvement rolling. Elizabeth led the lab through the renewal of their CLIA certificate, gaining ISO 15189 accreditation, and securing licenses with Massachusetts, Rhode Island, Pennsylvania, Maryland, Florida, California, and New York State.
Kate Lannon is a board registered RN with a BS in Nursing from Villanova University and is certified as a CCRN. Kate has more than 15 years of nursing experience working as a cardiac critical care nurse and as a nurse in the electrophysiology lab at an academic medial center in Boston. In addition, Kate works per diem at a medical research institute documenting adverse events for clinical trials.
At SSLC, Kate is our Nurse Regulatory Consultant and assists our team with point of care (POC) test auditing.
Fill out the contact form below and we will get back to you as soon as possible.