ABOUT US

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.

SERVICES

Complete regulatory support

Running a lab is complicated, demanding, and ever-evolving. We do our job so that you can do yours. We’ll make sure you have all your documentation for both Federal Compliance (CLIA, CAP) and State Licensures (MA, NY, CA, FL, MD, PA, RI. That way you can focus on what you do best, directing a high-performing 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.

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.

New Lab Start-Up

Personnel Qualification

Support of Training and Competency

Equipment Evaluation and Validation

Assessment of Laboratory Efficiency & Organizational Issues

Complete quality assurance program

Labs are busy places with myriad moving parts. It can be easy to get a report and forget to follow up, or lose track of an ongoing issue. That’s why we’ll take you through every step of the process and provide ongoing support. We work with you from the start-up, to pre-inspection, to routine quarterly QA Reviews of the lab.

As part of our ongoing support, we provide consistent QA Reviews - 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 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.

OUR TEAM

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.


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Joanne B. Lannon, M.Ed., DLM (ASCP)

Founder & President

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.

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Kathleen R. Oates, MT (ASCP) MPH

Director of Quality Assurance

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.

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Glenn Bouchie, MT (ASCP)

Senior Regulatory Consultant

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.

TESTIMONIALS

  • Brian J. Strasnick, PhD, JD
    Commonwealth Laboratories Inc
    Executive Chairman, Commonwealth Diagnostics International

    "SSLC has provided invaluable assistance with all technical and regulatory aspects of setting up our two laboratories. Joanne Lannon and her staff have been extremely professional and competent in dealing with our staff and educating them on the proper regulatory and operational requirements of both moderate and high complexity labs. I have started and operated four laboratories in my career and have dealt with many consultants. SSLC has been among the best I have engaged through the years. I can recommend them without reservation to anyone setting up a new lab or making an existing lab better."
  • T Forcht Dagi, MD, DMedSc, DHC, FAANS, FACS, FCCM, FRCSEd
    MRT Labs, Inc
    Anglo Scientific, The Royal Institution, London and Boston

    "We needed a rapid, expert assessment of operations in a fully-licensed specialty laboratory with a view to the standard of practice, and an expansion strategy. SSLC was receptive, thoughtful, prompt, professional, expert and communicative.

    "Both from a laboratory operations and from a consulting perspective, they exemplified what one hopes to encounter. I recommend them without reservation."
  • Olga Pozdnyakova, MD, PhD
    Harbor Medical Associates, Brigham and Women's Hospital
    Clinical Laboratory Director for Harbor Medical Associates and Cancer Center Physician Diagnostic Laboratory, Weymouth, MA and Aushon Biosystems, Billerica, MA.

    “I have been working with South Shore Laboratory Consultants for the past four years as a medical director of five CLIA and CAP-certified labs.

    "SSLC’s expertise includes all aspects of the state regulations, licensing and clinical test developments from initial stages of laboratory registration to overseeing maintenance and growth of existing labs.

    "SSLC’s knowledge, assistance and input greatly improve patient care.”
  • Douglas A. Hamilton
    Metastat
    President and Chief Executive Officer of Metastat

    “Receiving the Massachusetts state license for our digital pathology laboratory is an important step for MetaStat.

    “Working alongside the experts at South Shore Consultants, MetaStat has developed quality systems and procedures to ensure our next generation diagnostic products meet and exceed the rigorous standards of clinical practice as required by our customers.”
  • Mark Kellogg, PhD, MT (ASCP), DABCC
    Claritas Genomics
    Clinical Laboratory Director, Claritas Genomics, Cambridge, MA and Boston Children’s Hospital, Boston, MA

    “South Shore Laboratory Consultants is the most professional group I have ever worked with. Their attention to detail and willingness to work hard so your lab (and you) look great is unparalleled.

    "I’ve worked in the laboratory profession for almost 30 years and Joanne, Randee and Kathy taught me more about quality processes and inspection preparation than I thought possible. I cannot imagine starting a laboratory or trying to perform our internal audits without their assistance.

    "I look forward to continued assistance from South Shore Laboratory Consultants, knowing that our mission to provide high quality laboratory results is their mission also.”
  • John Curran, PhD, MBA
    Foundation Medicine
    Director of the Clinical Laboratory, Foundation Medicine, Inc., Cambridge, MA

    “There is a tremendous amount of work involved in building a lab, developing and validating assays, and preparing documentation in order to pass initial State and Federal inspections. South Shore Laboratory Consultants was instrumental in navigating me through that inspection process, allowing me to focus on the lab and assay.

    "If I ever need to repeat the process, the first call I'll make is to Joanne and Kathy.”
  • Kathy Behrens Wilsey, PhD
    KEW, Inc.
    Founder/CEO, KEW Group Inc., Cambridge, MA

    “We were referred to Joanne from another clinical laboratory who worked with South Shore Laboratory Consultants in preparing for MA State and CLIA licenses. Joanne and her team exhibited the Regulatory, Quality, and Compliance leadership we needed as a start-up company. Thanks to SSLC, we were able to pass inspection and obtain our MA State license in a very short period of time.

    "SSLC is a very professional, capable and dedicated team. We definitely plan to continue our relationship with South Shore Laboratory Consultants.”
  • Scott Evans, MBA, COE
    MERSI
    Chief Operating Officer, Massachusetts Eye Research and Surgery Institution, Cambridge, MA

    “We have worked with South Shore Laboratory Consultants for close to 10 years. They have consistently managed the regulatory compliance of our CLIA-certified clinical and pathology laboratories in a thorough and professional manner, and with the highest attention to detail.

    "SSLC has helped us to navigate the complexities of the state licensure process, as well as successfully overseeing all of our inspections.

    "I highly recommend SSLC for all your laboratory consulting needs.”
  • Alan E. Pontes, Executive Director
    Truesdale Medical
    The Truesdale Clinic, Inc.

    "SSLC has proven to be a great benefit in assisting our laboratory personnel by allowing them to focus on the day to day management of the laboratory."
  • Peter Martens, MD
    South Shore Internal Medicine
    Laboratory Director, South Shore Internal Medicine Associates, Milton, MA

    "Joanne Lannon has provided expertise in overseeing not only the technical aspects of the lab including reagents and instruments, but also compliance with quality regulations, both state and federal."
  • Charles G. Thornton, M.B.A., Ph.D., RAC
    OpGen
    Vice President of Quality & Regulatory Affairs, OpGen

    “The professionalism and thoroughness with which SSLC conducted our independent audit was outstanding. It has enabled us to focus on the details, processes and workflows that will allow us to improve compliance and efficiency.

    "It is a rare pleasure to work with consummate professionals with extensive knowledge and experience.”
  • Scott Tomlins, MD, Ph.D
    Strata Oncology
    Department of Pathology, University of Michigan Medical School

    "As a startup trying to rapidly enter the clinical testing area, SSLC was able to rapidly get us on the right path. Their insight into lab startup, compliance and connections were invaluable in our efforts to build out a high complexity testing laboratory.

    "SSLC was the right choice for us!"
  • Raaj Venkatesan
    Exosomedx
    Vice President of Regulatory Affairs and Quality, Exosome Diagnostics, Inc.

    “Joanne and her staff at South Shore Lab Consultants are an all-star team who guided us through the improvement of our existing Quality Management System. Their experience and expertise helped us complete a successful CLIA inspection and licensing in an effective, expeditious and efficient manner.

    “We had a previous team of consultants from outside the state of Massachusetts who had set up an ineffective Quality Management System. South Shore Lab Consultants were able to come in, perform a gap analysis, suggest corrective actions, and conduct follow-up audits to give us an effective Quality Management System compliant to both State and Federal CLIA regulations.

    “They carried out a very effective set of mock audits to prepare our Quality Management System for the CLIA inspection. In addition, they coordinated the scheduling of the inspection and facilitated the conduct of the inspection.

    “As a result, our Quality Management System is sustainable for compliance and for future accreditations/certifications.

    “They were not looking for short term assignments, but rather sought to understand the business needs and give us a long term sustainable approach to compliance in line with business needs.

    “Needless to say, we will be using them for our clinical laboratory’s compliance needs. We highly recommend South Shore Laboratory Consultants to other clinical laboratories.”
  • Peter A. Grape MD, FACC
    Harbor Medical Associates
    CEO, Harbor Medical Associates, South Weymouth, MA

    “We started our independent laboratory at Harbor Medical Associates about 20 years ago under the direction of South Shore Laboratory Consultants, and they have been directing and advising us ever since. Under their tutelage we have seen steady growth both in our volume and variety of services.

    "Initially CLIA certified, we became CAP certified 4 years ago with their assistance and direction. We now service over 500 patients daily and do so in an efficient and accurate manner.

    "They regularly survey all of our laboratory services and make certain we maintain the highest of standards as well as comply with all regulatory guidelines.

    "I can honestly say we would not be where we are today with respect to our laboratory services without their direction and advice.

    "I am extraordinarily proud of the service we provide our patients and I do not believe we could have achieved such high standards without the assistance of South Shore Laboratory Consultants.”
  • David Margulies, MD
    Q-State Biosciences
    Executive Director of the Gene Partnership at Children’s Hospital Boston, Boston, MA (Formerly President and CEO of Correlagen Diagnostics, Inc., Waltham, MA)

    "Joanne assisted Correlagen through the many phases of a start-up clinical genetics testing company: initial laboratory start-up with MA & CLIA licensing, change of location, many changes in staffing, and a growing test menu.

    "In addition, she guided us through the licensing application/inspection process, which yielded us a total of 9 licenses, including CAP and New York State.

    "South Shore Laboratory Consultants are true professionals and always worked in a highly collaborative manner with our staff. I would certainly work with Joanne and South Shore Laboratory Consultants again, and have passed her name onto many colleagues.”
  • Stephen Lyle, MD, PhD
    KEW, Inc.
    Clinical Laboratory Director for: KEW Group, Cambridge, MA, Beckman Coulter Genomics, Inc., Danvers, MA, and Eutropics Pharmaceuticals, Inc., Cambridge, MA

    "I have worked with South Shore Laboratory Consultants on 7 successful CLIA lab projects over the past 9 years. Joanne and her team have an encyclopedic knowledge of the state regulations for CLIA and Massachusetts, as well as NY, FL, CA, MD, PA and RI.

    "They allow the Laboratory Director to focus on the science and assay development for clinical testing."
  • Michael Cardone, PhD
    Eutropics
    Co-founder/President/CEO, Eutropics Pharmaceuticals, Inc., Cambridge, MA

    “South Shore Laboratory Consultants has been a tremendous help for our small biotech start-up, providing guidance and support during the CLIA certification process of our in-house laboratory developed test.

    "From test development to inspection, and all the documentation in between, Joanne Lannon and her team’s experience and knowledge of the Massachusetts State and Federal regulations were invaluable to the success of our clinical program.

    "Plus, their continuing quality assurance program reassures us that our program will remain reliable and robust.”
  • Joseph Repp, MBA
    Beckman Coulter Genomics
    Vice President/General Manager, Beckman Coulter Genomics, Danvers, MA

    “We are extremely pleased with the services provided by South Shore Laboratory Consultants to earn CLIA certification.

    "Working closely over the past two years, we received our MA, CLIA, MD, PA, and RI licenses.

    "They are assisting us in obtaining the remaining 4 - CAP, CA, FL, and NY. We used South Shore Laboratory Consultants as a start-up clinical laboratory service, and we continue to use them to assist us in growing and maintaining our licensing and quality systems."
  • Michael Laposata, MD, PhD
    Mass General Hospital
    Pathologist In-Chief/Laboratory Director, Vanderbilt University School of Medicine, Nashville, TN

    "South Shore Laboratory Consultants systematically tackled all the issues in my laboratory at Massachusetts General Hospital. The inspections were amazingly successful and the staff had nothing but praise. I would recommend South Shore Laboratory Consultants highly to anyone who needs help for an inspection."
  • Clayton M. Sparks, Operations Manager
    CVS
    CVS Caremark

    "I found Ms. Lannon to be professional, timely in her responses, and able to remain current on all regulations.

    "In addition, SSLC provided research on various regulations and was able to initiate and secure the appropriate contact in the states of MA, PA, and the District of Columbia that enabled our clinic services to open on strict timelines."

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