South Shore Laboratory Consultants
Our goal is the success of your laboratory
REGULATORY CONSULTING
Extensive Experience
QUALITY ASSURANCE AUDITING
Thorough Understanding
COMPLIANCE SOLUTIONS
Problem-Solving
Clinical Laboratory Consulting Services
Where Quality Meets Compliance
Since 1988, South Shore Laboratory Consultants (SSLC) has excelled in offering clinical laboratory consulting services, assisting labs in achieving CLIA certification, CAP accreditation, and State licensures, while providing continuous maintenance of regulatory and quality systems.
SSLC prides itself with its hands-on, friendly approach, effectively engaging with clients at both laboratory and administrative levels.
With a 100% success rate in compliance with regulations, our clients can rely on an expert partner to guide them throughout the process.
Services
Regulatory Compliance
New Lab Start Up
Lab Licensing Applications: CLIA, CAP, and State Licensure
Expert Regulatory Interpretations
Provide 50+ Policy and SOP Templates
Personnel Credentialing
LDT to IVD Transition
Regulatory Compliance
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Start up lab implementation
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Assistance with completing all required licensure applications.
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Federal CLIA
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Lab Accreditation: CAP, COLA
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Required In-State and Out-of-State applications, including NYS
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Expert regulatory interpretations
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Provides CLIA/CAP/NYS compliant policy and procedural templates
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Credential and personnel record review
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Review of initial equipment maintenance program
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Review assay validation for compliance with CLIA parameters
Quality Assurance
Provide Complete Quality Management Plan (Policy)
Internal Auditing
Identification of Non-Compliance with Best Practices for Improvement
Optimize Laboratory Operations
Continuous Improvement Support
On-site External Audit Support
Quality Assurance
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Structured audit plan including a review of pre-analytic, analytic, and post-analytic laboratory operations
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Audit of QA, QC, Proficiency Testing, Equipment Maintenance, and Training/Competency records
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Identification of non-compliance and recommendations for best practices
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In addition to non-compliance, opportunities for improvement are identified
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Provides report of detailed audit activities
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Continuous improvement support
Compliance Solutions
Customized Compliance Strategies
Expedite Inspection Plans of Correction
Offer Aid with CAPAs
Facilitate Communication with Regulatory Bodies
Project-Based Support
Tailored Gap Analysis
Compliance Solutions
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Inspection Preparation
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Custom Gap Analysis
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Offer customized compliance strategies
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Expedite inspection Plan of Corrections
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Offer aid with corrective and preventative actions
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Assist in all certification changes
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Facilitate communication with and submissions to regulatory bodies
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Assistance in overcoming the current state of non-compliance
We help clinical labs get started efficiently and effectively. SSLC provides comprehensive solutions to set your lab up for continued success. Don’t see what you’re looking for? Reach out and we can discuss a plan to fit your needs.
The SSLC Approach
Direct Communication, Strategic Planning, Seamless Execution
COMPLIMENTARY INITIAL CONSULTATION
Meet with us to discuss your objectives and our scope of services.
OUTLINE GOALS AND OBJECTIVES
Identify the lab’s regulatory goals and timeline.
FORMALIZE AGREEMENT
Develop a cooperative partnership to work towards accomplishing your goals.
EXECUTION PLAN
Collaborate with staff to achieve necessary licensures and certifications.
CONTINUED QA AND REGULATORY SUPPORT
Ensure continued compliance with all required regulatory standards through continued oversight and routine audits.
What Makes SSLC Unique
Experienced, Collaborative, Responsive, Trusted
Extensive industry EXPERIENCE at the bench, as lab supervisors, and as regulatory assessors.
Offer individualized hands-on approach through our collaborative RELATIONSHIPS. We become a part of your team working towards a collective goal.
Prioritize prompt and attentive COMMUNICATION through comprehensive responses to all our clients.
Known for our REPUTATION of proven success, our clients confidently refer us to their colleagues and repeatedly engage our services whenever they transition to new ventures.
Proven Results
SSLC is the pioneer regulatory consulting firm for clinical laboratories in Massachusetts. With the most established legacy and top-tier expertise it has grown to service laboratories throughout the US and internationally.
We cultivate long-term relationships, returning clients, and customer loyalty.
We quickly adapt to the ever-changing regulatory landscape.
We successfully lead our clients through countless State Audits, CLIA Surveys, CAP Inspections, and NYS surveys.
We reduce unexpected costs proactively by ensuring compliance.
Our Clients
Real Experiences, Real Results
Massachusetts General Hospital
Michael Laposata, MD, PhD, Pathologist In-Chief/Laboratory Director
University of Massachusetts, Amherst
Peter H. Reinhart Ph.D. Director, IALS and Clinical Professor, BMB
Northeastern University
Prof. Jared Auclair, PhD, Associate Dean of Professional Programs and Graduate Affairs, Director of the Biopharmaceutical Analysis and Training Lab (BATL), Technical Supervisor Life Science Training Center (LSTC)
Foundation Medicine
John Curran, PhD, MBA, Director of the Clinical Laboratory
Thomas Mullen, FACMG, PhD
Clinical Laboratory Director
Exosome Diagnostics, Inc
Raaj Venkatesan, Vice President of Regulatory Affairs and Quality
Travera, Inc.
Clifford Reid, PhD, Founder and CEO
Beckman Coulter Genomics
Joseph Repp, MBA, Vice President and General Manager
Stephen Lyle, MD, PhD
Clinical Laboratory Director
OpGen
Charles G. Thornton, M.B.A., Ph.D., RAC, Vice President of Quality & Regulatory Affairs
Q-State Biosciences
David Margulies, MD, Executive Director of the Gene Partnership at Children’s Hospital Boston (Formerly President and CEO of Correlagen Diagnostics, Inc.)
Harbor Medical Associates
Peter A. Grape MD, FACC, CEO
Olga Pozdnyakova, MD, PhD
Clinical Laboratory Director
Olink Proteomics
Narges Rashidi, PhD, Sr. Field Application Scientist
Sanofi U.S.
Deborah DiNoto, M.S., Associate Vice President of Translational Medicine and Early Development Project Operations
Aldatu Diagnostics
Iain MacLeod LL.M Ph.D, Chief Executive Officer
BostonGene
John Curran Ph.D., MBA, VP of Laboratory Operations
EpigenDx
Liying Yan, BMed, MS, President
Massachusetts Eye Research and Surgery Institution (MERSI)
Scott Evans, MBA, CEO
Strata Oncology
Scott Tomlins, MD, Ph.D, Department of Pathology, University of Michigan Medical School
Day Zero Diagnostics
Nicole Billings, Ph.D., Director of Lab Services
KEW, Inc.
Kathy Behrens Wilsey, PhD, Founder and CEO
Precision for Medicine
Rob Fannon, GM Biospecimen Solutions, Precision for Medicine
Akoya Biosciences
Nicholas Culhane, Laboratory Manager
Claritas Genomics
Mark Kellogg, PhD, MT (ASCP), DABCC, Clinical Laboratory Director
Metastat
Douglas A. Hamilton, President and Chief Executive Officer
MRT Labs, Inc.
T Forcht Dagi, MD, DMedSc, DHC, FAANS, FACS, FCCM, FRCSEd, Anglo Scientific, The Royal Institution, London and Boston
Commonwealth Laboratories, Inc.
Brian J. Strasnick, PhD, JD, Executive Chairman
Commonwealth Diagnostics International, Inc.
Gray W. Rifkin, Esq, Chief Operating Officer
Namida Labs
Mike Rutherford, Ph.D, Directory of Laboratory Operations
ProterixBio
Julio E. Herrera, Ph.D., VP, Assays
Alletess Medical Laboratory
Veronica Kent, Chief Executive Officer
Meet Our Team
Welcome to the heart of SSLC, where passion meets expertise
Joanne B. Lannon
M.Ed., DLM (ASCP)
Founder and President
Joanne B. Lannon, M.Ed., DLM (ASCP)
Joanne Lannon, the President and Founder has a remarkable career spanning over 35 years in laboratory medicine, Joanne has been a trusted advisor to diverse clinical laboratories since 1988.
As a pioneer in clinical laboratory consulting within Massachusetts, Joanne’s extensive experience has earned her an outstanding reputation. Professionals consistently recommend Joanne for her exceptional expertise and dedication.
Joanne holds a Master’s Degree in Education and is certified by the American Society of Clinical Pathologists as a Diplomate in Laboratory Management. Her academic success and practical experience guarantee exceptional leadership within SSLC and beyond.
Elizabeth Mullady
MLS (ASCP) CM, MHA
Director of Quality Assurance
Elizabeth Mullady, MLS (ASCP) CM, MHA
Elizabeth Mullady joined SSLC in 2018 as a Senior Regulatory Consultant and was promoted to the Director of Quality Assurance in 2022. Elizabeth is an ASCP Board registered Medical Laboratory Scientist with a Master’s degree in Health Care Administration. She is a highly respected professional with 20 years of experience in clinical laboratories. Prior to her work at SSLC she was as a technologist in the Infection Disease Diagnostic lab at Boston Children’s Hospital and then the Director of Quality Assurance and Regulatory Affairs at a molecular genetics lab.
Amy Marciniak
MS
Senior Regulatory Consultant
Amy Marciniak, MS
Amy Marciniak has an extensive background spanning 13 years at the Massachusetts Department of Public Health (MDPH) and brings a wealth of experience and expertise to the SSLC team.
During her tenure with MDPH, Amy held diverse roles showcasing her dedication and leadership in healthcare. Most recently as a Clinical Laboratory Surveyor for the Clinical Laboratory Program of the Division of Health Care Facility Licensure and Certification, Amy was responsible for inspecting laboratories to determine compliance with state laboratory regulations and federal CLIA regulations on behalf of CMS. Notably, her outstanding contributions during the COVID-19 Public Health Emergency earned her the prestigious Performance Recognition Citation from the DPH Commissioner in 2020.
Amy holds a Bachelor’s Degree in Biochemistry from Suffolk University and a Master’s Degree in Health and Medical Informatics from Brandeis University. Her blend of education and practical experience make her a valuable part of our team, as we continue to uphold the highest standards in healthcare.
Kate Lannon
RN, BSN, CCRN
Nurse Regulatory Consultant
Kate Lannon, RN, BSN, CCRN
Kate Lannon is a highly skilled board-registered RN holding a BS in Nursing from Villanova University as well as CCRN certification from the American Association of Critical-Care Nurses. With over 20 years of nursing experience, Kate has expertise in a wide variety of settings including cardiac critical care and the electrophysiology lab, within an esteemed academic medical center in Boston.
In addition to her clinical roles, Kate also contributes her talents to a medical research institute, where she documents adverse events for clinical trials on a per diem basis and also provides expertise to lawyers regarding review of medical records.
Joining SSLC as our Nurse Regulatory Consultant, Kate brings her wealth of experience to the team, specializing in point of care (POC) test auditing. With her dedication to excellence and meticulous attention to detail, Kate plays a vital role in ensuring regulatory compliance and upholding the highest standards of patient care within our organization.
Kathleen R. Oates
MT (ASCP) MPH
Regulatory Advisor
Kathleen R. Oates, MT (ASCP) MPH
Kathy Oates’ tenure began in 1993. She has been instrumental in SSLC’s success and expansion.
Prior to her role at SSLC, Kathy served as the Manager of the Clinical Laboratory Program at the Massachusetts Department of Public Health. With 30 years of experience as the Director of Quality Assurance at SSLC, Kathy brings a wealth of expertise to her current position.
Widely respected among her peers and renowned within the industry, Kathy is a certified Medical Technologist by the American Board of Clinical Pathologists. She holds a Master of Public Health degree from Boston University, further enriching her professional profile.
A Message from SSLC’s Founder & President
As the founder of this woman-owned business, I am filled with immense gratitude for the journey we’ve embarked upon together. From our humble beginnings, 35 years ago, on the South Shore of Massachusetts to becoming a cornerstone in this industry, every achievement is a testament to the dedication and passion that drives us forward.
I envisioned a company built on the principles of integrity, expertise, and collaboration. Over the years, we’ve not only upheld these values but have surpassed them, setting new standards of quality and service in our field. Challenges and triumphs have marked our journey, but through it all, our focus has remained steadfast: to provide unparalleled support to our clients, ensuring compliance, efficiency, and excellence in every aspect of their operations.
Today, as we reflect on our accomplishments, we renew our commitment to you, our valued customers, partners, and team members who have been integral to our success. We look forward to forging new relationships and continuing to build on our legacy. I am proud of what we’ve achieved together over the years, but I am even more excited about the future that lies ahead. With your trust and support, I am confident that we will continue to lead, innovate, and make a lasting impact in the clinical lab regulatory industry.
Thank you for being a part of our journey. Here’s to many more years of success ahead.
Warm regards,
Joanne Lannon
M.Ed., DLM (ASCP)