A dialogue with COLA’s new Chief Executive Officer, Nancy Stratton

Dec. 21, 2018
Nancy Stratton
Chief Executive Officer

Congratulations on your new position! What do laboratorians not familiar with COLA need to know? I am really excited and honored to be chosen by the COLA Board of Directors to serve in this capacity. Having been a customer, I’ve experienced firsthand the knowledge, talent, and skills of the COLA surveyors. The one thing that impresses me most is that each and every person—out in the field and at the home office—genuinely cares about serving our customers. This, combined with rock solid technical expertise, makes COLA a special organization. Staff members are completely enthusiastic about our mission. Teamwork is not something we work on, but rather the natural way we do our work. There is a high degree of collaboration and communication within COLA, which is important to providing exceptional customer service.

What advantages does a COLA certified lab have over one that is not? Clearly, the federal CLIA framework is the recognized government standard that all laboratories must meet. However, it is incredibly difficult for government authorities to pass laws and/or promulgate new regulations to keep pace with the tremendous innovation underway in laboratory science and the exponential growth in new methodologies.

At COLA, we do everything we can to stay current on new developments and assist our customers to navigate their dynamic environment. Due to the complexity of government regulations, we’re available to translate these regulations into accreditation criteria that can be practically applied and evaluated through a comprehensive, relevant, on-site survey. When compliance problems are found on site, we mentor labs to help them identify workable solutions. We expect laboratories to apply the highest standards of quality in their day-to-day operations and demonstrate continued accuracy and reliability of testing through successful performance of proficiency testing.

Our online customer portal can monitor a laboratory’s accreditation status in real-time, access educational materials and laboratory templates, upload documentation (including plans to achieve required improvements), and communicate changes as they occur.

Finally, COLA is an organization which holds itself to the highest standards as evident by the fact that we are the only laboratory accreditation organization that has pursued, and has been awarded, ISO certification for our Laboratory Accreditation Program. We participate in routine third-party external audits to ensure our quality-engineered processes that guide accreditation actions are operating as intended.

What are the steps for a lab to be accredited by COLA and what is the average turn-around-time? To enroll with COLA, a laboratory manager can fill out an application on our website or call to enroll. Once enrolled, we send the new customer a link to the COLA Accreditation Manual and a detailed Laboratory Information Packet to gather additional information.

Next, we provide online access to COLA’s Customer Portal. There the laboratory can complete a self-assessment based upon COLA criteria. Using the self-assessment report, laboratories can then make the improvements needed.

The COLA on-site lab survey is the centerpiece of the accreditation process. The surveyor will interact with lab staff and observe work in progress in addition to reviewing policies, procedures, and records. Preliminary survey findings are shared with the lab staff and educational guidance offered during the summary conference. COLA also provides the laboratory with a detailed survey report, citing all non-compliant issues identified at the time of the survey. In addition, COLA provides laboratories with educational materials, technical coaching, and advice. The lab then develops and implements a corrective action plan, providing us with appropriate documentation to demonstrate compliance. Upon successful completion of the survey and any required follow-up actions, the lab receives a COLA Certificate of Accreditation. Approximately 85 percent of labs receive their certificate within 90 days of their on-site survey.

When a laboratory enrolls with COLA, their initial on-site survey occurs within 11 months. Subsequent surveys occur every two years. COLA accredited laboratories are continuously accredited, without gaps, as long as they continue to stay in compliance with COLA criteria for accreditation, permit a survey every two years, and pay their accreditation fees.

How many laboratories does COLA currently serve? COLA accredits nearly 7,500 medical laboratories, which makes us the largest independent clinical laboratory accreditor in the U.S. COLA has long held the position that owners, directors, and laboratory managers should have a choice in terms of the accreditation of their laboratory. While this is a small industry in terms of the number of accreditors, I’ve discovered that while we are well known among physicians with office labs, small independent community reference labs, and some small community hospitals, we are not as well-known in other segments of the clinical lab market. Certainly, the consolidation of laboratories and the integration of healthcare providers are trends we are watching closely.

What profession other than your own would you like to attempt? I have always had a passion for laboratory medicine and patient care and honestly couldn’t imagine myself doing anything else. However, I would continue my work with veterans and horses. Back in Texas, I own and operate a horse ranch, which was part of the national nonprofit “Horses4Heroes.” This organization makes the dream of affordable horseback riding a reality for our troops, veterans, wounded warriors, and their families. Besides working with COLA, helping those people has been one of the most rewarding things I have done. The more we give, the more we receive.

Why does the COLA accreditation application ask these two questions: (a) Does your lab OR will your lab perform mass spectrometry analysis? and (b) Does your lab OR will your lab include what is commonly called a ‘blood bank’ section, where blood products are stored and lab staff perform testing to identify compatible units of blood products for transfusion? We are not only committed to quality and accurate test results; we are also dedicated to our customers and their satisfaction. In order to provide our laboratories with the best customer experience, we try to obtain as much information about them as possible during the application process. Also, laboratories may add specialties after enrollment which is why we routinely ask laboratories for updates. In some cases, laboratories are performing testing which requires certain expertise of the surveyor. In other cases, certain specialties and/or the size of a laboratory may necessitate a team of surveyors or extended time on site to provide the laboratory with the best survey possible. Having a good understanding of the disciplines of types of testing, such as mass spectrometry, as well as the size of the laboratory operation enables us to give optimal support to our customers.

Once a lab is enrolled, the website states, “COLA follows lab performance on a continuing basis, including monitoring proficiency testing.” What does this entail, exactly and how does this timeline roll out? The way COLA follows lab performance on a continuing basis is through the COLAcentral portal. Labs can use COLAcentral to help them stay in daily compliance with CLIA and COLA quality requirements and all appropriate state licensure standards. We have a team of experts called Technical Advisors at COLA, and they assist with any technical questions a laboratory may have. We also have a proficiency testing team who are experts in the knowledge of CLIA requirements and Proficiency Testing (PT). COLA’s continuous monitoring of required PT means we don’t wait until the biennial on-site survey to review and address PT failures. PT monitoring starts with the first PT event occurring after enrolling with COLA and continues for as long as the laboratory remains enrolled with COLA. For each PT event with unsatisfactory results, we provide the lab with a template for investigating the results, so that the root cause of the failure can be identified, and corrective action can be taken as quickly as possible. If a laboratory is not getting satisfactory results in PT, there is the potential that patient results will also be impacted, therefore it is critical to make sure corrective actions are taken promptly.

Why does the U.S. currently require only four states (CA, WA, NV and LA) to have special certification for phlebotomists and only 12 states and Puerto Rico (CA, FL, GA, HI, LA, MO, NV, NY, ND, RI, TN and WV) to license medical technologists? There are many different ideas about how to ensure that persons working in healthcare have the knowledge and technical competency to serve patients. Decisions about licensure and certification are primarily made at the state level so it is really no surprise that we see variations in requirements. Formal and informal education, on-the-job training, certification programs, the requirement for continuing education units, and licensure are all mechanisms to ensure that persons are competent. States simply differ on what they expect and what they codify in law. In addition, licensure and certification can be promoted by patient advocacy groups. Professional groups representing laboratorians have long advocated that trained laboratory scientists should be the required standard for performing non-waived testing. Several states have adopted that stance as well.

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