Are you prepared for an inspection? CCCLC can help you make sure you’ve met all regulatory requirements before your inspection.
We specialize in Freestanding Emergency Centers, Urgent Care Centers, and Physician Office Laboratories, but we have served all types of laboratories!
Our services to date have included over 100 labs:
- Over 30 Freestanding Emergency Centers
- Over 15 Urgent Care Centers
- Surgery Centers
- Small Rural Hospitals
- Large 100+ Bed Hospitals
- 10+ Pediatric Clinics
- OB/GYN Clinics
- Cancer Clinics
- Family Practice Clinics
- Heart & Vascular Clinic
- Physician Owned Reference Lab
- Fertility Center
- Immunology Lab
- Single Practice POLs
- Multi Provider Practice POLs
Our services are provided in the core areas of the laboratory: Hematology, Routine Chemistry, Coagulation, Immunology, Blood Banking, and Microbiology. We serve waived, moderate, and high complexity labs.
- Start-Up services for new laboratories
- Serving as your laboratory’s Technical Consultant for routine oversight
- Preparing for inspections or providing mock inspections
- Writing a Plan of Correction (POC) for CLIA or a Plan of Required Improvements (PRI) for COLA following an unsuccessful survey
- Providing remediation following an unsuccessful survey
- Serving as the Technical Consultant when mandated by CLIA or COLA sanctions following an unsuccessful survey
- Providing troubleshooting assistance when QC or PT not acceptable
- Establishing complete procedure and policy manuals
- Establishing a Quality Control (QC) and maintenance program
- Providing training and continuing education for staff
- Establishing a Quality Assurance (QA) program
- Enrolling in proper proficiency testing (PT) programs
- Review of personnel records
- High Complexity Toxicology (Drug Screen or Pain Management Labs)
- High Complexity Genetics Testing
- High Complexity Molecular Testing
Both locally and for our long distance associations we use a combination of electronic and on-site methods to provide our services. Many of our local clients use our services as their ongoing Technical Consultant on record with CLIA or COLA. We provide monthly on-site visits to review the lab and provide QA reports based on those reviews. Some labs choose to send their records for review by fax or email and they are reviewed remotely, with only a quarterly or semi-annual onsite visit.
Writing policies and procedures can usually be performed remotely. Temporary services such as assisting with writing a Plan of Correction can often be performed remotely.
Through a lucky internet search, I found the C&C Clinical Laboratory Consulting website, and decided to email them inquiring as to what they might be able to do to help us prepare for our impending inspection. Carol responded to my email in less than 24 hours, and briefly described what they could offer depending on the level of service we felt we needed. She explained that they could come to our site and conduct a mock survey, evaluate our laboratory based on CLIA standards, and offer feedback as needed. I felt comfortable with that option, and Carol’s partner, Cathy, just happened to be planning a trip relatively close to our clinic location.
With the site visit, Cathy spent over six hours reviewing our current laboratory operating procedures. She advised us on how to update our policies to better reflect CLIA standards, and helped us create a more useful quality assurance program. Overall, it was a very beneficial visit for us.
We contracted with Cathy and Carol for an additional 5 to 6 months after the site visit. During that time, Cathy acted as our Technical Consultant and corresponded with us electronically.
I am very pleased with the consulting I received from Cathy and Carol. I feel that the fees they charged were quite reasonable for what they were able to provide for our lab. We were never pressured into using their service or contracting with them for a longer period of time. In fact, they offered feedback indicating that we were ready to “stand” on our own prior to our official contract ending. Both Cathy and Carol are truly professional people that have a passion for what they do, and it shows in their work. They more than prepared our clinic for our survey, and I am happy to report that we passed.
Great news on the…COLA review. Thank you for your diligence and expertise that is so critical to our success!