
Laboratory Management Services for Clinical Labs
Cadence Lab Services offers expert lab consulting services tailored for physicians, wound care and urgent care centers, and nursing homes. Our specialized team guides you through every step—from regulatory compliance and lab design to equipment selection and staff training—ensuring your facility achieves efficient, high-quality diagnostic capabilities. With Cadence Lab Services, you gain a trusted partner dedicated to helping you streamline operations, improve patient outcomes, and maximize revenue with a turn-key approach to in-house laboratory setup.
Who We Are
Cadence Lab Services was started by physicians for physicians. When we provide you with guidance, it comes from the experience of running our own labs as well as recruiting the top lab management talent for your lab.
Guidance is provided to avoid common mistakes and leverage profitable opportunities.
This method supports sustainable growth and informed decisions. A sustainable lab elevates the speed and quality of your care to your patients.
Dedication to Our Clients
We’ve empowered countless urologists, OBGYN, podiatrists, dermatologists, family practitioners, GI’s, surgeons, wound and urgent care centers, and nursing homes to start their own clinical labs. These laboratories range in scope from new ventures just getting off the ground to established facilities seeking expanded capabilities or compliance upgrades. By providing a broad set of solutions, our consultants at Cadence are able to address issues throughout the entire lifecycle of a medical laboratory.
Key Service Areas:
- Application Handling
Many labs encounter setbacks with application paperwork. Experienced consultants streamline the process by taking charge of complex forms such as CMS-116 and related documentation, reducing the risks of costly mistakes and delays. - Quality Assurance Systems
Quality Management Services form a central part of laboratory oversight. Professional teams implement systems that keep labs compliant with accrediting standards, operating efficiently, and ready for inspections. - Test Menu Guidance
When forming a test menu, labs must consider both what their personnel can manage and what is required by their intended scope. Consultants help develop practical, compliant menus and explain how test complexity definitions may impact staffing. - Remote Data Review
Regulatory oversight is improved with remote data review. Laboratories can maintain up-to-date quality control and documentation without dedicating extra in-house resources.
Laboratory Design and Buildout Process:
Creating a high-performing laboratory space takes careful planning and real-world experience. Consultants work directly with contractors and instrument vendors to structure laboratory layouts that support efficient workflows and optimized personnel movement. Input is provided at every stage, ensuring each buildout fits both current and future needs.
Selecting Equipment and Supplies
A well-equipped lab is more than an inventory list. Advisors assist with selecting relevant equipment, reagents, and supplies that match laboratory goals while controlling unnecessary costs. This process considers current and planned testing capabilities, so laboratories invest wisely.
Ongoing Support and Consulting
Continuous support is crucial in the ever-changing laboratory environment. Consulting services are available under monthly retainers, offering direct access to teams for technical troubleshooting, menu updates, and business questions. Availability during the workweek allows labs a responsive partner ready to help address operational concerns as they arise.
Experience Across Varied Laboratory Functions
Labs benefit from high-complexity laboratory director expertise, especially when introducing new test offerings. Consultants validate new tests in multiple specialties, such as:
Specialty |
Example Tests |
Toxicology |
Drug screens |
Genetic Testing |
CGx, PGx assays |
COVID-19, other panels |
|
Allergies |
Allergy-specific assays |
Test validation by seasoned professionals ensures compliance with standards and accurate integration into the existing test menu.
Business Growth and Strategic Guidance
Lab managers look for sound advice when planning the next phase of business growth. Expert teams analyze operations and present solutions tailored to the lab’s specific goals. This includes proforma analyses to weigh the feasibility of planned expansion, as well as intelligence on shifting market trends.
Regulatory Navigation
Accreditation is a cornerstone for trustworthy laboratory operations. Consultants advise clients through the entire accreditation process with agencies such as CLIA, COLA, and CAP, as well as state-specific requirements. They assist with applications, updates, and paperwork, clearing bureaucratic hurdles and expediting credentialing so laboratories can focus on testing.
Inspection Preparation and Due Diligence
Laboratories preparing for federal or accrediting agency inspections gain the benefit of pre-inspection audits. These proactive reviews spot potential issues, allowing correction before any regulatory body visit. Such assessments also aid buyers when evaluating the purchase of an existing laboratory.
Training and Staff Development
A critical part of ongoing laboratory success is staff training. Consultants provide programs covering operation of instruments, laboratory information systems, data review, and even management best practices. Training options include onsite, remote, and classroom settings, accommodating different learning needs.
Standard Operating Procedures (SOPs) and Documentation
Every laboratory’s compliance hinges on well-written and complete SOPs. Experienced writers develop documentation that meets requirements set by national and state authorities, including general SOPs and procedures unique to each lab’s specialty and workflow.
Commercialization and Market Access
For labs developing new test technologies, consultants leverage their industry network to support market entry and commercial expansion. This may involve aligning with partners throughout the healthcare sector, ensuring new developments gain the reach they need.
Sample Consulting Service Overview Table
Service Area |
Description |
Benefit |
Application Support |
Handles all forms and submissions |
Faster approvals, less error |
Test Validation |
Oversees setup and proof for new tests |
Compliance, accurate implementation |
Ongoing Support |
Retainer-based expert access |
Troubleshooting & updates |
Quality Management |
QMS planning and maintenance |
Inspection readiness |
Training |
Custom lab and IT training |
Skilled, compliant staff |
SOP Writing |
Technical and compliance documentation |
Meets regulatory requirements |
Commercialization |
Bringing new tests to market |
Expanded reach, revenue growth |
Insights and Business Intelligence
Data-driven insights guide labs to make sound decisions. Business intelligence services provide up-to-date market information, competitor analysis, and forecasts, equipping lab managers to remain flexible and informed in a dynamic environment.
Laboratories that partner with experienced consultants for these and related areas have demonstrated greater readiness for compliance, smoother expansions, and improved efficiency in day-to-day operations. Access to an experienced team strengthens the capacity of labs to execute new initiatives and confidently tackle evolving industry standards.
Who Benefits from Our Services?
The team works with a wide range of laboratory organizations, including:
- Physician Office Laboratories
- Managed Service Organization Labs
- Independent Reference Laboratories
- Private Pathology Practices
With deep experience supporting thousands of labs across the U.S., their specialists have helped build and manage hundreds of laboratory operations. This expertise ensures tailored support for each client’s needs, helping to establish, operate, and expand high-quality facilities at various stages of growth.
Specialized Laboratory Consulting Solutions
Specialized consulting firms in the laboratory industry provide a range of tailored services to support clinical and independent laboratories. Their expert toxicologists design cost-efficient testing procedures and adapt to a broad selection of drugs, utilizing advanced LC/MS equipment from leading manufacturers. Custom assay development is available to align testing protocols with specific laboratory requirements.
Services also extend to clinics and labs seeking to implement or expand Infectious Disease testing. Consultants assist with rapid laboratory validation processes, enabling faster onboarding of high-margin testing that can benefit both operations and patient outcomes. Many labs are now exploring the Direct-to-Consumer (DTC) testing space, which presents unique compliance and operational challenges. Professional consulting teams assist labs and entrepreneurs in successfully navigating these complexities.
A highlight of their offerings is the Molecular Diagnostic Testing Program, which enables labs to add a variety of advanced services—including Pharmacogenomics (PGx), Cancer Genomics (CGx), Infectious Disease, and Liquid Biopsy—typically within a three-month timeframe.
Key Service Areas:
- Custom drug testing method development
- Infectious Disease test validation
- Direct-to-Consumer (DTC) lab setup support
- Rapid implementation of molecular diagnostics
Innovation in Laboratory Services
Sustainable laboratory commercialization involves strategic insight into regulatory requirements and reimbursement processes. Key considerations include navigating federal guidelines, such as the FDA’s final rule, and developing clear coding strategies to ensure proper payment for newly developed tests. We solve the problems for you and implement the solutions so you can focus on patient care.
Effective thought leaders adopt the following approaches:
- Stay current on regulatory changes
- Prioritize robust coding methods
- Focus on financial sustainability of you lab
Focus Area |
Key Action |
Compliance |
Monitor FDA regulations |
Reimbursement |
Develop clear coding plans |
Market Readiness |
Assess financial impact |
Frequently Asked Questions
Required Expertise and Credentials for Laboratory Consultants
Laboratory consultants usually need a strong background in laboratory science, such as a degree in biology, chemistry, or a related field. Many also hold professional certifications or have previous experience managing or supervising laboratory operations. Continuing education and industry-specific training can further enhance their qualifications.
Ways Consulting Services Improve Laboratory Performance
Laboratory consulting firms often assist with process optimization, workflow improvements, and staff training. They help labs implement best practices to increase productivity and reduce inefficiencies. Consultants may also provide advice on equipment selection and technology updates.
Common Professional Growth Paths in Laboratory Consulting
A typical path starts with hands-on laboratory work, then progresses into supervisory or specialist roles. Many consultants have prior experience in clinical, research, or analytical labs before shifting to consulting. Some may pursue advanced degrees or certifications to strengthen their expertise.
Key Functions of Consultants in Clinical Laboratory Settings
In clinical labs, consultants help ensure that testing protocols are accurate, quality control measures are maintained, and regulatory requirements are met. Duties may include auditing lab practices, offering guidance on accreditation, and assisting with troubleshooting complex cases. They may also train staff on compliance and safety procedures.
Support Provided by Consulting Firms for Regulatory Compliance
Consulting firms guide laboratories in understanding and applying industry regulations such as CLIA, CAP, or ISO standards. They offer compliance audits, develop documentation, and update labs on regulatory changes. These services help minimize the risk of non-compliance and support successful inspections.
Recommended Approaches for Streamlined Laboratory Management
Consultants often encourage the use of clear organizational structures, documented procedures, and ongoing staff education. They may recommend adopting laboratory information management systems (LIMS) or Lean methodologies. Regular performance reviews and risk assessments are also suggested to maintain high standards and adapt to changes.
Find Out How Much Your Current Lab Work is Worth
Cadence Lab Services will help you calculate your current labwork for 2 months to show you the potential margins on bringing a lab-house. Our turnkey solutions take all the guess work out of your investment and empower you to provide the highest quality and fastest care to your patients.
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Dr. Kia Michel
Urologist and Lab Management Expert
Kia Michel MD is co-founder of Cadence Lab Services. A renowned urologist, he opened his own in-house lab when he realized that he could improve patient outcomes in his urology practice, Comprehensive Urology in Beverly Hills, by having the power of fast test results. He shares his knowledge of the lab industry to empower other clinicians to take control of their own lab work.