COLA, a clinical laboratory accreditation organization, has released a list of the 10 most frequently cited reasons for laboratory citations by its surveyors. The results are based on accreditation surveys conducted to meet U.S. CLIA and state regulatory requirements between 2008 and 2010.
Zerela Henry, COLA's education division manager, noted inspectors continue to see citations issued for personnel responsibilities, monitoring the quality control program and implementing quality assessment.
The Top 10 reasons citations are issued include:
- lacking procedure for voluntary FDA reporting of device-related adverse events;
- not verifying materials used as controls by repetitive testing to meet manufacturer's established parameters for mean and standard deviation;
- not labeling specimens with a unique patient identifier composed of two individual identifiers and the source of the specimen (when appropriate);
- not performing calibration verification according to the manufacturer's instructions including: the number, type and concentration of materials to be used; use of materials at low, medium and high values within the reportable range as determined by the laboratory; acceptable limits for calibration verification, once every 6 months or more often, if required by laboratory procedures;
- not following manufacturer's instructions for the use of reagents, controls and kits;
- one or more laboratory employees not adequately fulfilling the responsibilities for the positions they hold;
- not preparing and plotting quality control data for each quantitative test performed with each testing event, or not calculating statistical indices to permit the laboratory to assess continued accuracy and precision of the method;
- personnel records not containing documentation of education and experience to qualify employees for the positions they hold in the laboratory;
- not documenting personnel education in the FDA procedure for voluntary reporting of device-related injuries and/or malfunctions; and
- laboratory director or qualified designee not regularly reviewing the quality control data with laboratory personnel.
Depending on the potential risks to patients, actions for random citations can vary from providing required documentation to undergoing another survey, Henry told ADVANCE. "Laboratories that fail to maintain improvements may be at risk for a loss of accreditation if a continued pattern of non-compliance is observed," she noted. "This may result in the lab director losing the ability to bill for patient testing for a limited amount of time."
According to Henry, the key to preventing citations is educating laboratory staff about how changing technology (e.g., test systems, health records) are impacting the regulatory landscape, and thusly, their patients and their roles. "Laboratories need to institute a solid training program and assess ongoing competency, not only with the operation of instruments, but also with specific company policies and procedures," she said.
To help, COLA has begun to offer Webinars and symposium events related to these key areas to provide additional education for labs. They also have technical consultants available to provide one-on-one virtual assistance before and after the survey.
COLA is urging laboratories to use their online tools for self-assessment surveys to prevent citations. "While some of these problems are more serious than others, the reality is that all are avoidable by completing the voluntary self-assessment that COLA urges all laboratory managers to take before the actual survey is conducted," said Douglas Beigel, COLA chief executive officer.
|IMRPOVE DEFICIENCIES: COLA's online portal can help lab managers examine their practices and improve upon problem areas before an inspection. ADVANCE photo
He added COLA's electronic portal, called COLAcentral, (http://www.colacentral.com/) makes easier than ever before for managers to perform the self-assessment, with an online wizard which customizes the survey to a laboratory's specific test specialties. "This self-assessment provides laboratories with the guidance and tools they need to ensure accurate test results, run their laboratory in accordance with quality systems, and meet CLIA requirements, thereby helping to avoid such citations," Beigel stressed.
COLAcentral helps laboratorians manage the regulatory compliance process, even linking them to their COLA surveyor, Beigel noted. Laboratories with Certificates of Waiver also can access the site by clicking on the "New to COLAcentral" tab on the homepage.
The portal also provides a dashboard wheel which displays compliance status information and an electronic filing cabinet for storing information such as laboratory director forms and proficiency testing results. Managers also can use the tool to automatically update their laboratory profile and other records, eliminating the need to fax such information, while receiving news alerts, survey results and support for a wide range of other laboratory needs, Beigel reported.
"Studies have shown that a noticeable percentage of waived sites are not meeting minimal requirements and are not aware of recommended practices to help ensure quality testing," Beigel said. "COLAcentral provides an easy-to-use and affordable solution to this problem, by allowing waived laboratories to access our growing library of more than 60 online courses as well as a variety of other resources that help them improve performance."
By educating staff on potential citation areas, they will become more aware of their roles within the organization and become empowered to exceed customer and supervisory expectations, Henry added.
"In addition, a focus on education keeps staff aligned with ongoing quality improvement measures and expands their skills and knowledge which improves the individual mindset," she said. "This mindset changes the culture of the company because the job is done right every time which reduces overall costs, minimizes risks to patients and allows staff to perform in a blame-free environment."
As a result, if and when non-conformities occur, everyone gets involved and supports the corrective actions implemented. Patients are assured they are being diagnosed and treated based on reliable test results. Henry asked, "Could you ask for anything more?"
Kerri Hatt (firstname.lastname@example.org) is managing editor of ADVANCE.