South Shore Laboratory Consultants

From the moment we engaged with SSLC, their expertise was apparent. Their regulatory insights were always spot-on and tailored to our needs, which brought clarity and confidence to what can otherwise feel like an overwhelming process.
We had the true honor to work directly with Amy Marciniak. What impressed us most was how Amy went the extra mile in everything she did. Whether it was diving into the specifics of our lab setup, explaining regulatory requirements in plain language, or walking our team through the steps with patience and understanding, she consistently delivered more than we expected. Her thoughtful teaching approach ensured that every member of our team felt aligned, informed, and empowered. She didn’t just deliver advice; she helped us understand the “why” behind it, which strengthened our confidence and clarity.

In short: SSLC embodies excellence in expertise, responsiveness, dedication, and collaboration. I wholeheartedly recommend SSLC to any organization looking for regulatory consulting support done with integrity and heart.

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.

We have been working with South Shore Laboratory Consultants for several years. We became associated with them when we were looking to become CLIA certified. Working with them was one of the best decisions we made. Coming from a Research and Development background, the steps needed to become CLIA were not obvious to us. SSLC and their staff made the transition for us possible, efficient, and painless. We continue to work with them and their support in maintaining our CLIA lab has been invaluable. They are professional, knowledgeable, and extremely helpful. I would highly recommend SSLC to anyone, without reservations, needing to gain an understanding of the function and requirements needed for running and maintaining a certified clinical lab. All I can say is “Thanks SSLC for all of your help and support”.

In late April/early May Northeastern University decided to set-up their own, MA licensed, CLIA certified COVID-19 testing lab. In so doing, we brought on SSLC to help us with the process.

SSLC, Joanne, and Liz, 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.

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.

I have worked with Joanne Lannon and the South Shore Laboratory Consultants (SSLC) team several times over the past 10 years. Starting up a CLIA lab to offer innovative genomic testing to physicians and patients is a monumental task. Knowing I have access to SSLC’s breadth of experience, I feel confident the lab would not only maintain compliance but exceed MA State License and CLIA certification requirements. In addition, I could lean on their experience to help grow the lab and obtain out-of-state licenses, and create an executable roadmap for NYS permitting and CAP Accreditation. I value the expertise of the SSLC team and highly recommend them to all of my colleagues.

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.

While SSLC has provided regulatory support for a number of large companies, we put them to the test of supporting a 7-person raw startup with virtually no clinical expertise. They took us from a standing start to a CLIA-certified lab in less than twelve months, an extraordinary accomplishment. They provided checklists of actions and reviews of results at every step of the way. They enabled us to design and execute a rigorous process that fits into our resource constraint and enabled us to sustainably meet our ongoing regulatory requirements with minimal burden on our scientific staff. I highly recommend them for startups embarking on an uncharted regulatory journey.

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.

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.

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.

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.

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.

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.

We have been working with SSLC for the past year to get our Boston lab certified as a high complexity CLIA lab. Joanne has been extremely professional, resourceful, and communicative guiding us through all the stages of this path and educating our team on all the different aspects of CLIA regulation.

Our customers demand high standards from Olink Proteomics and SSLC certainly helps us to deliver on that!

I have already recommended SSLC to many of our external colleagues and will keep doing so without any reservations. You make it so simple!

I cannot say enough about South Shore Lab Consultants and the support they provided us with our regulatory and licensure needs for the Clinical Specialty Lab.

Joanne and her team have been excellent in their support in providing advice, preparing for inspections, point on with their professionalism in assisting with connections to state organizations, and excellent at delivering clear and concise information regarding compliance.

I would like to extend a thank you to the team for all of their efforts and I highly recommend South Shore Laboratory Consultants to support your laboratory activities.

As a diagnostics R&D company looking to move into the clinical testing services space, the steep learning curve required to launch a new CLIA-approved lab seemed incredibly daunting. Yet the efficient and readily comprehensible approach taken by Liz, and the rest of the team at South Shore Lab Consultants, taught us more than I thought possible. Their professionalism and attention to detail coupled with their mentoring meant that we were incredibly well prepared for our (successful) inspection within a very short time after engaging with SSLC.

Despite the breadth of knowledge that SSLC has equipped us with, it brings us an incredible amount of reassurance to continue working with SSLC for their ongoing support and feedback to ensure that we maintain the high level of quality and compliance that they have helped us build. We only wish we’d found them sooner.

When I was tasked for the 3rd time with building a new clinical laboratory and taking it through the regulatory process, the first call I made was to SSLC. They had come through for me twice before and this time was no different. Thanks to their hands on approach, constant availability, and superior set of documentation, SSLC helped us obtain our CLIA and CAP licenses in very short order as well as facilitating the required applications for other state licensure. I highly recommend SSLC for any organization needing expert help in clinical diagnostic start up.

For the past 15 years, SSLC has guided EpigenDx from the initial consultation in setting up our CLIA-certified lab to CLIA, MA, and CA inspections and internal/external audits. Their thorough understanding of CLIA and various state regulations and hands-on approach helped us streamline our operations and improve our compliance. We highly recommend their services to any lab seeking expert CLIA consulting.

I spend a lot of time working with early-stage diagnostic companies in the Boston area. The conversation inevitably turns to: Who do you recommend to help with getting your lab’s CLIA license? There is just one consistent answer: South Shore Laboratory Consultants – or simply South Shore when discussing over coffee. I first heard about Elizabeth Mullady and her colleagues when a colleague raved about working with them. That was a decade ago, and now there isn’t a CLIA lab where I know the team that hasn’t taken advantage of the deep expertise, tried-and-true processes, and excellent service that SSLC provides.

In my last role, we all appreciated the reassurance and systems SSLC brought to the company as we prepared for CLIA launch. We started with an empty lab and strong research results, added South Shore Laboratory Consultants’ guidance, and we achieved our CLIA license on time and on budget!

I strongly recommend South Shore Laboratory Consultants as the go-to for regulatory and CLIA lab operations consultants.

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.

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!

I cannot speak highly enough of South Shore Laboratory Consultants (SSLC). As a startup venturing into the complex world of clinical testing for our epiXact HAI services, SSLC helped DZD to efficiently navigate regulatory compliance to build our high-complexity testing laboratory. What sets SSLC apart is not just their expertise, but their unwavering professionalism and thoroughness. Their independent audits are conducted with exemplary precision, providing us with invaluable insights to enhance compliance and improve quality workflows. Joanne and Liz, in particular, have been exceptional in guiding us through the intricacies of CLIA licensing for our lab. Their professionalism, resourcefulness, and clear communication have been indispensable in every stage of the process. SSLC continues to be an integral consultation partner in our ongoing success and I highly recommend their services without hesitation.

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.

SSLC was the perfect partner for us. The firm offered an unparalleled level of depth and breadth of state and federal requirements – and helped us secure our CLIA license in record time. We’re incredibly grateful.

SSLC are experts in their field. They helped us take our lab from the R&D space into the CLIA world. This was a large change for our team, and SSLC took the time to speak with all our team members during this process. We heavily rely on their expertise in all matters of regulatory compliance. SSLC is available at a moment’s notice to help with any emergencies that arise. They are deeply trusted by the whole Akoya staff.

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 and her team 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.

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.

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.

As a laboratory director who has worked with South Shore Laboratory Consultants in multiple laboratories for over a decade, I can confidently say that SSLC is an outstanding partner in ensuring CLIA compliance and excellence. Their expertise, attention to detail, and commitment to quality and regulatory compliance assure that the laboratories they work with consistently meet and exceed the industry standards. I highly recommend their services to any laboratory striving for compliance and operational excellence.

South Shore Laboratory Consultants (SSLC) were instrumental in guiding us from our startup phase into growth. They helped us navigate Massachusetts state licensing, CLIA certification, and the New York State permitting process. Their on-site audits have been vital for maintaining our CAP Accreditation and ensuring ongoing compliance in all fifty states. I’d recommend them to any lab, at any stage of development.

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.

CDI has utilized SSLC’s services for many years in both setting up our laboratories and obtaining licensure at the state level through MassDPH and the federal level through CLIA. SSLC has also provided CDI with essential guidance on international clinical laboratory standards such as ISO 15189. In addition to preparing CDI’s laboratory for successful state and federal inspections, SSLC has seamlessly lead our team through various administrative changes and notification processes, including change of laboratory directors. SSLC has a knowledgeable team that provides professional, responsive, flexible, and seamless laboratory consulting services. We remain particularly impressed by how quickly SSLC’s team was able to understand the peculiarities of our lab and adapt to our organization’s needs. SSLC’s ability to engage with our people and guide us through critical processes has been invaluable to our team.

We approached SSLC early in the process of setting up our CLIA laboratory to deliver our novel biomarker assay to market. While we had significant scientific expertise inhouse, we lacked clinical laboratory and regulatory experience. SSLC walked us through the process of setting up and certifying our CLIA laboratory. This included identifying CLIA roles which could be filled by personnel already on staff and those which required us to look outside of our company.

As a start-up company, time and money are critical to our success. By partnering with SSLC, we easily recouped our monetary investment and shaved months off of the timeline. Their SOP package not only was easy to customize but SSLC was always available to answer questions as they arose and to review any SOP we needed.

One of the most significant payoffs of working with SSLC arose when we pivoted to COVID-19 testing just prior to opening our laboratory. SSLC provided the expertise we needed to execute the pivot and expedite our “go-live” timeline. Our partnership with South Shore Laboratory Consultants has proven to be one of the best investments we have made.

We have been working with South Shore Laboratory Consultants for several years. We became associated with them when we were looking to become CLIA certified. Working with them was one of the best decisions we made. Coming from a Research and Development background, the steps needed to become CLIA were not obvious to us. SSLC and their staff made the transition for us possible, efficient, and painless. We continue to work with them and their support in maintaining our CLIA lab has been invaluable. They are professional, knowledgeable, and extremely helpful. I would highly recommend SSLC to anyone, without reservations, needing to gain an understanding of the function and requirements needed for running and maintaining a certified clinical lab. All I can say is “Thanks SSLC for all of your help and support”.

Navigating the regulatory landscape while operating a clinical laboratory can be overwhelming. Last year 2 experienced laboratory supervisors retired, and we promoted 2 technicians to first-time general supervisors. The support, experience, and knowledge of South Shore Laboratory Consultants allow our laboratory to focus on testing samples and delivering accurate test results efficiently, while keeping us on track for CAP Accreditation. I love to see the smiles on the laboratory team after a successful audit, knowing we are in compliance is the best feeling, thank you!