What is COLA? Overview & Brief History
The Commission on Office Laboratory Accreditation (COLA) is one of the most recognized laboratory accreditors in the United States. It’s dedicated to improving healthcare and patient care in laboratories nationwide through its accreditation and educational services. By partnering with medical laboratories, COLA aims to make the accreditation process simple and quick while meeting their needs. The certificate demonstrates the quality system of organizations, patient care, healthcare workflows, laboratory quality, and the accuracy and reliability of the results produced by the labs.
Its straightforward strategy helps clinical laboratory professionals easily meet CLIA requirements. Further, its LabUniversity® platform provides them with continuing education opportunities to improve their healthcare services and skills.
In 1993, the Health Care Financing Administration (now CMS, Centers for Medicare and Medicaid Services) granted COLA with the deeming authority for laboratory accreditation, which was later also recognized by the Joint Commission (TJC).
Now, COLA, Inc. is a physician-directed accreditation organization and sole accreditation provider whose program runs under an ISO 9001:2015-certified quality management system.
Medical labs eligible for COLA accreditation include office labs, mobile labs, community hospital labs, and other reference laboratories. However, labs whose CLIA certificate has been revoked within 24 months are not eligible to operate a COLA-accredited laboratory.
Currently, the company is headquartered in Columbia and led by Nancy Stratton, the company’s Chief Executive Officer (CEO). Some other key people of the organization are Kathy Nucifora (COO), Susan Densford (Director of Accreditation), and Danielle Stroughton Duncan (Director of Education Division).
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COLA vs. CLIA
COLA and CLIA (Clinical Laboratory Improvement Amendments) follow the same regulatory requirements. However, there are minor differences regarding how they intersect. Some of those distinctions are summarized in the chart below:
|COLA works at the national level and its inspectors move across states for inspection of labs to ensure consistent implementation of the regulation.||CLIA regulation is administered at the state level and the quality of implementation differs between different states.|
|It performs correlation studies between the new and old installed instruments for performance comparison.||It doesn’t involve any such studies for instruments.|
|It requires that the old and new control lot numbers overlap at least five times.||It requires the overlapping of old and new control lot numbers but doesn’t have any specific number limit. |
Throughout this article, we will examine all of the prerequisites for COLA’s laboratory accreditation program. We’ll also review how your laboratory can earn the accreditation certificate after the complete implementation of COLA and CLIA regulations.
How Does the COLA Accreditation Process Work?
In addition to meeting CLIA and other regulatory requirements, COLA-accredited clinical labs also benefit from its educational products and services, which help companies achieve accreditation.
COLA’s five-step accreditation approach is designed to streamline the accreditation process and collect all the required information for the improvement of the laboratory’s quality system. It’s a straightforward process where:
- First, COLA prepares the laboratories using its educational tools before performing on-site surveys.
- Laboratories’ standards are evaluated based on COLA criteria.
- COLA then develops a customized accreditation approach that best fits the medical organizations applying for the accreditation.
Figure: An illustration of the five-step accreditation process of COLA.
1. Apply for enrollment
To apply for the COLA accreditation, the first step is to:
- Sign up with COLA
- Set up your account
- Provide laboratory information
- Pay the enrollment fee
After payment, you will receive COLA’s welcome packet containing:
- Enrollment letter
- Laboratory Information Packet
- COLA Accreditation Manual CD
- Forms to perform the self-assessment
- Three administrative forms:
- Form VI: Laboratory Director Signature Form, which outlines COLA’s and the laboratory’s agreement.
- Form IX: Annual Test Volume, which is used by the labs to report their annual test volume.
- Form XI: Proficiency Test Data Release Form, which authorizes the proficiency testing provider of labs to send proficiency test results to COLA.
You must submit all of the above forms to COLA, along with any other general laboratory information, to begin the accreditation process.
Note: Some organizations, like AACE, AAFP, ACP, FMA, MLE, are eligible for a discount for the COLA accreditation.
After enrollment, labs are required to perform self-assessment to evaluate their performance before an on-site survey. All the information provided implies if the laboratory complies with each criterion mentioned in the form.
The questions in the self-assessment form outline COLA’s Criteria for Quality
Laboratory Performance, which is also used by the COLA surveyors during the on-site surveys and evaluation of laboratories.
After the submission of the self-assessment form, labs’ responses are reviewed by COLA. At this stage, any non-compliances are identified. Thereafter, COLA will inform laboratories of these non-compliance and ask labs to make improvements before the on-site survey.
3. On-site survey
COLA surveyors visit the laboratory for on-site surveys. They will review your documentation, quality assurance, and proficiency testing activities. From the obtained information during the survey, the surveyors will also examine the lab’s process and its ability in delivering on-time, accurate, and reliable results.
At this time, laboratory staff must also guide surveyors through labs and answer all/any questions they have. All general, research, and healthcare staff must be familiar with all the policies and procedures of the lab.
4. Post-survey & corrective action
Lastly, the surveyors share the survey summary with the lab director and healthcare staff. They mention any additional non-compliant criteria (if any are still found), and offer further education and training guidance as necessary.
Surveyors send a data report from their on-site visits to COLA, after which COLA generates a separate report noting the lab’s accreditation status. COLA also sends a Plan of Required Improvement (PRI) to laboratories containing information on the remaining areas of non-compliance.
After identification of non-compliances, COLA helps the laboratories to take corrective actions by providing educational materials, support and advice, and hand-on consultations.
Lastly, labs are required to create and implement a corrective action plan and submit all the appropriate required documents to COLA.
After correcting all non-compliant criteria, the laboratories are provided with a COLA Accreditation Certificate. The accreditation certificate is valid for a total of two years.
During the two years, COLA continues to monitor lab performance and help labs to maintain the state licensure standards and federal regulations.
How Excedr Can Help Labs Receive Lab Accreditations
The COLA accreditation program assists healthcare providers and physicians in effectively operating a lab that adheres to federal regulations and operates at optimal efficiency. The program has five key steps to accredit labs with a COLA accreditation certificate and foster excellence in clinical laboratory operations.
Excedr helps labs to accelerate their accreditation process through its custom and flexible leasing program.
Our program allows labs of all sizes to procure the cutting-edge equipment required to enhance lab efficiency and streamline lab workflows.
With Excedr’s extensive portfolio of general and clinical products, you can outfit your lab with the equipment you need. Additionally, our experts will assist you with any maintenance or repair concerns you might have related to the procured equipment.
If you’re interested in learning more, get in touch with one of our leasing reps today.
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