Inspection Preparation
Inspection Preparation
Our pre-inspection audit services will help identify potential issues before a scheduled inspection and ensure regulatory requirements are met for those seeking to purchase an existing clinical lab. By isolating and addressing these issues before your upcoming CLIA, COLA, or CAP inspection, you can ensure a successful inspection process and reduce deficiencies across all evaluation areas.
Technical Training & SOPs
Technical Training & SOPs
Get the technical training your laboratory personnel needs relating to software, operating instruments, toxicology data review, lab management, and more.
- Training is available on-site at your location or remotely
- We develop and compose technical and general Standard Operating Procedures and Quality Management plan(s)
- Ensure compliance with applicable CLIA, CAP, COLA, Joint Commission, and State documentation requirements
Laboratory Management
Laboratory Management
Our management team will provide the skills and knowledge necessary to keep your laboratory productive and running smoothly. We’ll supply you with a team of expert consultants with over 12 years of combined experience.
- Hematology
- Immunoassay (IA)
- Clinical Chemistry
- LCMS Clinical Toxicology
- Microbiology,
- Molecular Testing Methodologies
Method Development & Validation
Method Development & Validation
We can aid your lab in selecting an appropriate test menu (adhering to testing personnel requirements), developing methods for customized toxicology panels and laboratory-developed tests (LDTs), and validating new tests in specialties such as toxicology, CGx, PGx, infectious disease, hematology, immunoassay, clinical chemistry, digital PCR, and more.
Ongoing Consulting & Support/Remote Data Review
Ongoing Consulting & Support/Remote Data Review
Enjoy ongoing consulting and support 7 days a week for a single monthly retainer fee. Our team of experts will remain on call to answer any technical or operational questions, provide troubleshooting assistance, walk you through product training, and help with anything else you need.
With our convenient remote data review services, you can ensure patient results comply with the highest quality standards in the industry. Our success depends on the success of your laboratory, which is why we’re committed to delivering exceptional customer service with everything we do.
Regulatory Consulting & Application Processing
Regulatory Consulting & Application Processing
Ensure all applicable licensing and accreditation requirements are met with regulatory consulting on the application process for CLIA licensure, CAP, and COLA accreditation. Our team is well-versed in all state and federal laboratory quality qualifications needed to keep your facility compliant.
To eliminate unnecessary stress and patient testing delays, we can also complete and file the following application types:
- CMS-116
- CLIA
- CMS Region VI Toxicology Specialty
- NPI Medicare, California, Maryland, New York, Nevada, Pennsylvania, and Rhode Island