Turn-Key Lab Set Up
Let our experienced laboratory consulting professionals help you start, grow, and run your lab.
We offer comprehensive or itemized packages as an efficient and cost-effective means to start your own Physician Office or Independent/Reference Laboratory.
Helix Molecular Solutions can provide:
- Application Processing (CLIA, CAP, COLA, etc.)
- Test Menu Development
- Laboratory Design
- Standard Operating Procedures
- Method Development
- Validation/Verification Studies
- Proficiency Testing Setup
- Lab Staffing Recruitment
- Technical Training
- Mock Inspections
- Quality Assurance Plans
Quality Assurance Program
A laboratory quality assurance (QA) program involves the entire testing process: pre-analytical, analytical, and post-analytical processes.
CLIA regulations address specific quality assurance requirements. 42 CFR 493 states that laboratories “must establish and follow written policies and procedures for a comprehensive quality assurance program that is designed to monitor and evaluate the ongoing and overall quality of the total testing process.” The QA program must:
- Assess the effectiveness of the lab’s policies and procedures.
- Identify and correct problems.
- Assure the accurate, reliable, and prompt reporting of test results.
- Assure the adequacy and competency of the staff.
- Initiate corrective action when problems occur and document all quality assurance activities.
CLIA regulations specify ten different standards to be included in a laboratory’s quality assurance program:
- Patient test management
- Quality control
- Proficiency testing
- Test comparisons
- Relate results to clinical data
- Personnel
- Communications
- Complaints
- Staff review
- Records
We offer custom comprehensive QA program plans as well as ongoing QA maintenance plans.
Additional Laboratory Services
Panel Design
Our experienced clinical laboratory professionals can help guide you to build clinically actionable and reimbursable test panels. Waived, moderate and high complexity testing options available, including, but not limited to:
- Molecular Genetics (Biosafety Level: BSL I)
- Molecular Microbiology (Biosafety Level: BSL I-BSL III)
- Chemistry
- Hematology
- Immunology
Assay Validations
Assay validations can be complex and time consuming. Efficiently launch your next test panel by allowing our experienced clinical laboratory professionals design and write your assay validation plans. Waived, moderate and high complexity testing options available, including, but not limited to:
Molecular Genetics (Biosafety Level: BSL I)
- Pharmacogenetics
- Inherited Cancer
- Carrier Screening
- Nutrigenomics
Molecular Microbiology (Biosafety Level: BSL I-BSL III)
- Vaginitis
- Nail Fungal
- Urinary Tract Infections
- Sexually Transmitted Infections
- Wound
- Respiratory
- Gastrointestinal
- Antibiotic Resistance
Chemistry
- Toxicology Drug Screening and Confirmation
- Blood Chemistry
Hematology
- Complete Blood Counts
- White Blood Cell Counts
- Reticulocyte Analysis
- Coagulation Tests
Immunology
- SARS-CoV-2 Antibody Tests
- Rapid Plasma Regain (RPR)
- Tumor Marker Testing: CA-125, CA 19-9, CEA
Technical Training
Don’t have experienced technologists to perform new testing? No problem. We can train your technical laboratory staff in new methodologies and standard operating procedures.
Proficiency Testing Sourcing
Proficiency testing is an essential component to ensuring the accuracy of laboratory tests and is regulated by CLIA. There are multiple CLIA approved proficiency testing programs available, but not all programs offer the same proficiency testing options. Additionally, many molecular assays do not have CLIA approved proficiency testing programs available, and thus require alternative assessments for assay performance. Alternative assessments can include:
- Split-sample testing with another laboratory
- Split-sample testing with established in-house method
- Chart review
- Participation in graded/ungraded/educational proficiency testing
Navigating and sourcing all of the required proficiency testing and properly documenting proficiency testing performance can be time consuming and stressful. Let us handle sourcing and documenting all of your proficiency testing needs to ensure that you are in compliance with all applicable regulations.
Audit Preparation
Don’t let an unannounced inspection by a regulatory body or 3rd party payor put your lab at risk of closure. Helix Molecular Solutions mock inspection services can provide an unbiased in-depth review of your lab's compliance . We know it can be a stressful and long process, so let us handle it for you.
Standard Operating Procedure Creation
Standard operating procedures (SOPs) are an essential component to any laboratory and must be written and approved by the CLIA Lab Director before being put in use. SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with laboratory regulations. CLIA and other regulatory bodies require that specific types of SOPs and specific content be in written form. Helix Molecular Solutions will ensure your laboratory is up to compliance standards and handle the daunting task of writing and composing your procedures for you.