CLIA & COLA Consulting Services

Assuring Your Laboratory’s Success
in Today’s Regulatory Environment

CLIA, the Clinical Laboratory Improvement Amendments, and COLA, the laboratory accreditation program, enable laboratories to meet the high standards of today’s regulatory requirements.

At DTPM, we offer experienced consultants and fast, dependable methods to bring your lab into compliance with CLIA and COLA. We keep you on track with proven protocols and procedures, including ongoing equipment calibration.

Our consultants are available to work side-by-side with your team to assure success in meeting quality standards for methods development, proficiency testing, quality control, patient test management, personnel qualifications, and more.

Contact us for more information on how we can help your lab with all of its regulatory compliance needs.

DTPM's CLIA & COLA Consulting Services

Our Professional Consulting Services Include

Application Processing

We will file your CLIA application for you and assure that it is done correctly. Mistakes at this level can contribute to months of wasted time which translates into lost revenue.

Technical Supervisors

When you lab needs or is required to have an ongoing technical supervisor we will make sure you have the person you need. We will work with you on a monthly basis to assure that you and your laboratory are in compliance.

Policies & Procedures

We will provide you with your own personalized set of professional bound policies and procedures for your laboratory. We will assure that you are in complete compliance.

Validation

DTPM consultants can assist you with finding a qualified lab director and assure that they have reviewed and approved the validations and that are available in your laboratory.

Lab Directors

Our team of recruiters maintain a list of qualified laboratory directors for your lab. Finding qualified directors is vital toward getting your CLIA application filed and lab running specimens.

Mock Inspection

Prior to your inspection we will be in your laboratory to perform a MOCK INSPECTION. We will assure you are ready and then will stand by your side during the official inspection process.

Choose the Package That’s Right for You


CLIA Turnkey Package

A high complexity package, the CLIA Turnkey Package includes the following:

Price: $2,500 | Monthly

  • High Complexity Lab Director.
  • High Complexity Technical Supervisor to Perform Data Review.
  • Filing CLIA application and assistance with CLIA compliance and COLA accreditation.
  • CLIA Laboratory Audit Support.
  • Assistance with Proficiency Testing for regulated and non-regulated analytes.
  • Creation and maintenance of validation manuals.
  • Verification of Performance Specifications for all Test Methods (Accuracy, Precision, Specificity).
  • Annual Safety Training & Competency Training with personnel required by CLIA and COLA.
  • Providing DTPM Representative On-site During all Inspections.
  • Ongoing monitoring of quality assurance (QA) and quality control (QC).
  • 24/7 Technical support.


Initial Startup Package

A high complexity package, the Initial Start Up Package includes the following:

Price: $1,500 |One-time fee

  • Filing CLIA application and assistance with COLA accreditation.
  • Document Specificity of all analytes, Linearity of Calibration, Reportable Ranges, and Defining Limit of Detection.
  • Verification of Performance Specifications for all Test Methods (Accuracy, Precision, Specificity).
  • General Laboratory Procedures, Lab Equipment Procedures, Operational Procedures, and Quality Assurance / Quality Control Procedures.
  • Written Personnel Policies with Job Descriptions.


Moderate Complexity Adjustment Package

Adjust your laboratory from filing as High Complexity to Moderate Complexity:

Price: $1,500 | One-time fee

We will assist you with the complexity adjustment of your laboratory by doing the following:

  • File an adjustment to your current CLIA from High Complexity to Moderate Complexity.
  • Adjust Policy and Procedures as needed.
  • Technical Consultant to Perform Data Review.

The benefits of running a Moderate Complexity Laboratory include the following:

  • The physician or other qualified personnel with an M.S. or B.S. can potentially become the Laboratory Director of the laboratory with the correct criteria.
  • The Testing Personnel can potentially be an existing employee with a high school diploma or equivalent with proper documentation of training.

Moderate Complexity Ongoing Coverage

Keep your laboratory up to date on current CLIA/COLA regulations:

Price: $800 | Monthly

Our team will take on the burden of staying up-to-date with changes to regulations within the industry to ensure your laboratory is never lacking in it’s compliance.

Ensure you and your staff are performing to the best of standards, and pass that confidence along to your clients!

Our dedicated staff will keep your laboratory up to date on current CLIA/COLA regulations and on track with proven protocols and procedures, including ongoing equipment calibration.

TRUSTED SERVICES PROVIDED BY

PROVIDING SERVICES TO CUSTOMERS NATIONWIDE

As you start out with your laboratory you need professionals standing behind you and ready to work to assure you are in compliance with your state and national regulatory agencies.  DTPM will provide you the confidence that you need.  We will have you validated and running specimens faster than anyone in the industry.  Let our team work for you no matter where you are located in the United States, for CLIA & COLA Consulting, or any of your other laboratory management needs.

SERVICES THAT WE PROVIDE INCLUDE

DTPM Total Program Management Services

our services OFFER YOUR LAB UNMATCHED ASSISTANCE


TECHNICAL SUPPORT

24-7 Support for your technical needs.

We will support your lab with assistance when you need it! Operators are available 24-7 to answer your questions.

ANSWERS TO YOUR QUESTIONS

We provide the answers you need.

No matter your problem, our experienced consultants have the background and expertise needed to solve any issues.

ONSITE DURING INSPECTIONS

We will be there with you during inspection.

Rest assured your inspection will go smoothly with our experienced support by your side throughout the process.

ONGOING MONITORING

Ongoing monitoring of your QA compliance.

We provide ongoing monitoring of your CLIA Compliance through every phase of your laboratory.

Our guarentee To You

Quality

We guarantee to provide you with a quality product. Our professionals are dedicated to our service.

Satisfaction

Your satisfaction is our goal. We won’t stop until you are satisfied with the product we provide you.

Integrity

Integrity is the key to our success. Our staff will act ethically and adhere to high standards, moral principles and honesty.

Hear from Our Satisified Customers


We are very pleased with the professionalism and quality services provided by the CLIA consultants. It is very important that our labs are up and running as soon as possible. We installed a lot of labs last year and they kept up with them with no problem. These consultants make it happen.

– Sam Snead

We have always been happy with the performance of the CLIA consultants. It has taken a lot of work off us and we appreciate the way these consults handle our customers. They are very service oriented.

– John