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Laboratory Consulting Services

Waived & Moderate Complexity Testing Consulting

Lighthouse Lab Services specializes in helping laboratories navigate the intricacies of waived and moderate complexity testing across the U.S. Our expert team of consultants provides tailored solutions for lab startups, regulatory compliance, staffing, and ongoing quality management.

Whether you are launching a new lab or enhancing your existing operations, we offer the expertise and support needed to ensure your lab’s success and growth. Learn more about how partnering with us can streamline your processes, maintain compliance, and achieve excellence in laboratory management.

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Waived & Moderate Complexity Services Overview

Lighthouse has a proven track record of successful lab launches and management. We provide dedicated support for compliance, management, and growth, and offer customized solutions tailored to specific laboratory needs and budgets.

Key Services:

  • Lab startup planning and regulatory compliance support.
  • Staffing, training, onboarding, and recruiting support.
  • Part-time lab director and technical consultant guidance and services.
  • Quality management, audit preparation and continuous lab quality improvement.

Who We Serve: Comprehensive Support for Diverse Laboratory Settings


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Physician Office


biotech
Reference Labs


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Hospitals


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Urgent Care Centers


medication
Pharmacies


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Public Health Labs

If you perform point-of-care testing, did you know this?

Smaller physician offices conducting point-of-care testing can seamlessly expand into moderate complexity testing with their existing staff. Lighthouse Lab Services offers comprehensive management consulting to help your office remain compliant and efficiently manage all necessary documents and logs. Our expertise ensures that you have the support needed to navigate this transition smoothly, even if your team lacks the specialized knowledge. Partner with us to enhance your testing capabilities and provide higher quality care to your patients.

Solutions Breakdown for Waived & Moderate Complexity Labs

1. Lab Startup Services: Comprehensive Planning and Support


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Planning: Facility design, equipment procurement, and regulatory compliance support to ensure a successful lab launch.


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Compliance: Assistance with licensing, accreditation, and SOP development, utilizing Lighthouse’s expertise and vendor partnerships.


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Staffing: Comprehensive staff training, onboarding, and recruiting support, including training programs for clinic staff and quality management.

2. Part-Time Lab Director and Technical Consultant


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Part-Time Lab Director: Offering competitive pricing for part-time lab director roles, ensuring laboratories meet their operational and compliance needs affordably.


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Technical Consultant: Providing expert technical consultant services tailored to your laboratory challenges.


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Flexible Engagement Models: Including payment plans, to support labs in various stages of growth and development.

3. Ongoing Quality Support: Ensuring Excellence Beyond Startup


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Quality: Dedicated to continuous quality improvement, audit preparation, and quality management systems for troubleshooting and issue resolution.


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Ongoing Management: Proactive problem solving with a dedicated account management point of contact, ensuring excellence beyond startup.

4. Waived Labs Offering: Comprehensive Quality Management


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CLIA Guidance: Handling CLIA applications and updates, personnel training, competency documents, and monitoring for waived labs.


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QA Program: Implementing a comprehensive QA program, document control, QC requirements, logs and forms, and regulatory compliance support.


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Education: Providing OSHA and HIPAA continuing education courses, along with corrective and preventative actions for complete compliance.

"We love Lighthouse. Incredible support. Great account management. Superior technical support. We all talk about how great it has been to work with [Lighthouse]. We cannot say enough positive about the company. "

R. Scott LaNeve, General Manager, Drugscan, Inc.

"Lighthouse Lab Services has helped us set up our physician office lab for urine toxicology. They are very professional and organized. I would highly recommend their services."

Julia Ashford, Ashford Pain Solutions

"My lab just finished the validation of a Turn-Key Covid-19 lab using Lighthouse Lab Services. We had a great experience and are looking forward to future projects as we grow. They assisted with everything from finding equipment, supplies, validation and training. I highly recommended them."

Ameritech Diagnostic Labs

"We are all impressed with the work that Lighthouse Lab Services does to help the clinical laboratory community... We have been working tirelessly over the last year tackling all of the complexities involved in starting up a clinical lab from scratch… We are… overjoyed to have [a lab director] onboard via Lighthouse."

Christine Barnard, Founder & CEO, Atlas Quality Assurance Laboratories

"I want to commend your team (again) for being such great partners. Your service levels have been the best of any of our Covid suppliers – instrumentation, supplies, and/or reagents. We are grateful we found Lighthouse and look forward to working together."

Consulting & Covid Assay Client

"We hired a MLT and Lab Director thanks to Lighthouse and everything has been smooth sailing. They are both knowledgeable, thorough, professional and have helped our practice tremendously. Thank you again Lighthouse for matching us perfectly."

Jeremy

"Impressive Team and always ready to serve!"

Shea Harrelson, Vikor Scientific

"Lighthouse is professional, responsive, and has always provided quality candidates."

Charlene

"It’s my pleasure working with Lighthouse on recruiting our Lab Director. [Candidates]…spoke highly of your company. They trust the quality service and the transparency your team has provided them. We can certainly understand why we feel the same way about your knowledge in the lab field and Lighthouse Lab Services putting the clients’ interest at heart."

Reference Lab Recruiting Client

Partner with us to enhance your testing capabilities and provide higher quality care to your patients.

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FAQs

What is the difference between waived and moderate complexity testing?

  • Waived Testing: These tests are simple to perform and carry a low risk of incorrect results. They are often used in point-of-care settings.
  • Moderate Complexity Testing: These tests are more complex and require additional training, quality control, and documentation to ensure accuracy and compliance with regulatory standards.

Can my physician office transition from waived to moderate complexity testing?

Yes, physician offices can transition from waived to moderate complexity testing. This expansion allows for more comprehensive diagnostic capabilities. However, it requires proper training, documentation, and adherence to compliance standards.

What are the benefits of transitioning to moderate complexity testing?

  • Enhanced Diagnostic Capabilities: Offers a broader range of tests to improve patient care.
  • Increased Revenue: Potential to generate more income from a wider array of tests.
  • Improved Patient Outcomes: Faster and more accurate diagnosis and treatment plans.

What steps are involved in transitioning to moderate complexity testing?

What kind of support does Lighthouse Lab Services offer for this transition?

  • Regulatory Compliance: Assistance with licensing, accreditation, and developing standard operating procedures (SOPs).
  • Staff Training: Comprehensive training programs for your current staff to handle moderate complexity tests.
  • Documentation and Quality Control: Helping you set up and maintain the necessary documentation and quality control measures.
  • Ongoing Support: Continuous support to ensure your lab remains compliant and operates efficiently.

How do we ensure we stay compliant with CLIA regulations?

  • Regular Training: Keep your staff updated with the latest procedures and compliance requirements.
  • Quality Control: Implement rigorous quality control measures.
  • Consultation: Regularly consult with experts to review and update your compliance protocols.

Have a question? Contact us.

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