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Set Up Your Own Pathology Laboratory

Getting a laboratory off the ground can seem like a daunting project to most practice owners. At SigmaCore, we provide superior laboratory management services to simplify and expedite your pathology lab set-up. Our practice management consultants provide streamlined end-to-end turnkey laboratory management solutions. Regardless of where you are in the lab set-up process, we can help you overcome the challenges of planning, running and maintaining your own in-house laboratory through our broad range of services.

Pathologist looking into a microscope with laboratory informatics in the background.

Our Turnkey Laboratories Can Be Found Nationwide

Physician Offices

Hospitals

Physician Groups

Laboratory Industry Experts

Our team has been helping practice owners build and maintain their own turnkey laboratories across the nation for over a decade. Among our experts are laboratory supervisors and pathologists with up-to-date knowledge on the industry regulations, equipment and best practices.

We Specialize in Turnkey Pathology Laboratory Solutions

We provide global, technical (TC) and professional (PC) support for services including GI, GU, oncology, dermatopathology and more in the following lab categories. We take a patient-centric approach and offer a business analysis that considers your volume and lab information system features (such as client portals) to create a custom proforma so you can make the smartest decision.

Histology Labs

Immunohistochemistry

TC/PC Labs

Flow Cytometry Labs

Cytogenetics Labs

Digital Pathology

Our Laboratory Consulting Services Include:

  • Oversight by Pathologists
    SigmaCore employs a number of practicing board certified pathologists with expertise across various subspecialties. Our pathologists ensure the highest level of technical and clinical support for your laboratory as they oversee all its processes.
  • Laboratory Build
    The SigmaCore team, with our multidisciplinary expertise, will work with your team and manufacturers to develop a successful and efficient laboratory space catered to your needs. SigmaCore provides valuable support to the practice from the beginning, starting from the space choice and lease to the acquisition and design. We work with your architect and engineers to achieve a streamlined process that will allow for an optimal workflow. Our method always takes the vision of your practice into consideration as we provide step-by-step guidance throughout your journey.
  • Application Filing
    During the process of laboratory building or enhancement, SigmaCore will help you file for the licenses necessary from your state and federal agencies. We will ensure that you are compliant by helping you seek accreditation and certifications based on the testing performed at your practice and guide you through the paperwork renewal process.
  • Staffing and Training
    We provide different levels of staffing and training services, ranging from a complete management solution where SigmaCore provides and manages the staff, to as-needed support only when there are specimen surges. The latter option can help you avoid hiring unnecessary full-time employees. SigmaCore is also able to provide technical supervision and training of your employees, whether it’s on-site, at a different facility, or virtually, so they can acquire new experiences and see a larger operation.
  • Periodic Site Visits
    SigmaCore management and technical consultants will conduct periodic visits to your laboratory to proactively prevent falling out of compliance and provide consistent support to your team. SigmaCore is always available to visit your practice anytime you feel a need for support. We also provide over-the-phone support or videoconferencing, if preferred.

  • Patient-Specific Panel Design
    Based on your patient population, our team of pathologists and scientists will work hand-in-hand with the practice providers to design a panel (or set of panels) that will provide all the tools necessary to make a fast and clear diagnosis in a cost-efficient way.
  • Equipment Selection and Validation
    Our technical team has extensive experience in the field of anatomical and clinical pathology and understands the importance of making the right choices when it comes to equipment and reagents. Our proposals and recommendations are based on your unique sample volume and turnaround time expectations. We also ensure that all equipment specifications and safety requirements are met, including all the electric, plumbing, airflow, exhaust and waste disposal needs.
  • Leasing vs. Purchasing: Equipment/Reagents Acquisition
    Acquisition of a new instrument or hardware can be achieved through several ways: Capital purchase, lease, reagent rental or a combination of these options. Each situation is unique and requires careful consideration to make the most out of the new acquisition. SigmaCore is here to guide you along the way to ensure maximum cost savings.
  • Supply and Reagent Selection and Rentals
    As healthcare industry experts, we can help you recognize and make the best strategic choices when contracting through partner suppliers and manufacturers, so you can achieve the maximum financial benefit for your practice.
  • Rapid Test Turnaround Times
    To stay competitive and better serve the patient, accurate and fast test results are crucial. A streamlined and optimized workflow using well-designed, standard operating procedures will ensure that results are of the highest and consistent quality while always meeting turnaround time benchmarks.

Did you know that workflow efficiency is directly linked to test quality and profitability? Achieving an efficient process will ensure the greatest amount of cost savings for you and your practice. Our team of experienced project managers and technical advisors will help you create optimum processes for maximum profitability.

  • Budget Analysis/Cost Savings
    Starting up a lab, adding a new discipline to your existing lab or expanding your testing menu can present many challenges. One of the most common and hard-to-tackle challenges faced by practice owners is understanding and managing your budget. SigmaCore will help you overcome this difficulty through a comprehensive budget analysis that includes the four major components of a lab budget:
    · Lab space
    · Personnel (salary, benefits, furniture)
    · Equipment
    · Supplies and consumables
    SigmaCore will provide a comprehensive analysis of the project and present solutions that align with your vision and allow for a profitable operation based on current volumes as well as account for scalability to cover future growth.
  • Test Menu Expansion
    If you’d like to add a testing line to your lab to stay competitive, offer the latest technologies or find new ways to bring in additional revenue, SigmaCore can help. Our experienced team will help you add new test lines in as little as 60 days. Our goal is to strike the perfect balance between efficiency and going live as quickly as possible while not putting too much stress on your staff throughout the process.
  • FTE Analysis
    If your goal is to achieve an efficient operation, then planning the number and type of employees you will need to hire should be a top priority. SigmaCore can help you analyze your needs for employees. Several parameters are taken into consideration, including scheduling, vacations, sick leave, salaries, benefits, full-time vs. part-time and automation vs. employees. A detailed analysis will be conducted based on industry standards and your unique needs to establish the optimal setup.

Employee competency is often indicative of a lab’s testing quality. SigmaCore offers a comprehensive solution to maintain the competency of your employees and keep them up to date in all aspects of testing, required trainings and continuing education through our training competency program. Your employees will be trained by a team of educators with academic backgrounds and decades of experience in the clinical field.

Compliance and Accreditation

Throughout the course of building a lab and adding/improving a process or test, our team of dedicated consultants will help you stay compliant and satisfy (if not surpass) all CLIA requirements. Our team of consultants is comprised of highly trained medical technologists, PhD’s and pathologists that have decades of experience in clinical labs. We are extremely familiar with CLIA compliance and can be a great help when preparing for an inspection or addressing the deficiencies that you might have acquired during past inspections.

As such, our CLIA consultation services include assistance with application submission (initial or otherwise), inspection preparation and remediation response, if needed.

SigmaCore offers a wide range of options to support your regulatory compliance needs, from total oversight and management to a simple consultation. As participating inspectors for the College of American Pathologists (CAP), our experienced staff has personally inspected some of the nation’s largest reference labs and hospitals. Your practice could benefit greatly from the trained eye of our team as we help you achieve the highest inspection scores and ensure you stay inspection-ready at all times. Our compliance readiness services are available on both a recurring basis and on-demand.

SigmaCore offers support in writing policies and procedures for regulated laboratory processes with the goal of improving efficiency and consistency. We take into consideration industry best practices, manufacturers’ guidelines and OSHA guidelines for safety. Beyond general policies, we can also help you standardize HIPAA policies and procedures, technical standard procedures (SOP’s) and a quality assurance plan for your practice.

We will work together with your team to develop a custom QA plan that will guarantee the highest product quality. A QA plan is designed to monitor, evaluate and improve the quality and appropriateness of laboratory services and patient results through the following objectives:

  • Planning, designing, measuring, assessing, and improving new or revised processes of patient care and service
  • Identifying opportunities through continuous assessment of systems and processes of care through a collaborative and non-punitive approach
  • Implementing solutions and actions which will bring positive patient care outcomes
  • Maintaining a safe working environment for personnel, patients and visitors

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