Laboratories are required to perform analytic validation of clinically relevant performance specifications of each method used. All laboratories must establish accuracy, precision, analytical sensitivity, analytical specificity, interferences, and reportable range as applicable.
The validation of a new analytical method is primarily concerned with the identification of the sources of potential errors, and quantification of the potential errors in the method.
Lab Me's partner laboratories follow all the necessary steps to
document the performance specifications of every test currently available to health awareness participants and physician clients.
These documents are routinely evaluated by the certifying agency during on-site inspections and compliance is necessary to maintain accreditation. Lab Me has also made available to clients a validation summary for each laboratory test in the form of technical bulletins for quick review by clients and other users of Lab Me services.
You can request those by leaving a message here that says "Validation Summaries" please indicate which biomarker you are interested and allow up to 3 days for your request to be processed.
In order to maintain federal certification, state licenses (permits), and CAP accreditation, Lab Me partner laboratories are also required to demonstrate laboratory proficiency through external and internal quality assessment.
Lab Me's partner labs participate in several external proficiency testing programs from the College of American Pathologists.
The CAP Survey is the largest laboratory peer comparison program in the world. Approximately 23,000 laboratories throughout the world are enrolled in the proficiency testing programs of the CAP. The programs allow laboratories to regularly evaluate their performance and improve the accuracy of the patient results they provide.
Through this program, the CAP provides individual laboratories with unknown specimens for testing. The participants analyze the specimens and return the results to the CAP for evaluation. In turn, each participating laboratory receives a report
Lab Me's partner labs' Risk Management is defined by policies and procedures to prevent future events resulting in potential loss.
Different elements of the Quality Improvement program define the mechanism by which the laboratory becomes aware of potential adverse future events.
The laboratory Quality Improvement program aims to document ongoing mechanisms to identify and correct problems at any level of laboratory operations.
Lab, Me's partner labs, outline four elements for successful quality improvement: Evaluation of complaints from laboratory clients, review of incidents/ exception reports, evaluation of deficiencies cited by external assessments (CAP), and review of proficiency testing results.
This quality management initiative allows Lab Me's partner labs to establish performance measurements consistent with our client's expectations and meet quality expectations. The results are documented in the annual survey for laboratory clients.
These activities aim to ensure the same results are obtained at all testing sites. The Chief Scientific officer actively identifies the best method for each test and standardizes processes across testing sites to ensure high-quality and consistent results, regardless of testing location.
Lab Me by receiving final reports have the responsibility in compliance with and adherence to the CAP Laboratory General Checklist (CAP GEN.48500) to validate and verify that the contents of their health awareness participants reports transmitted to their servers or participants' medical record compares to our partner labs Laboratory Information Management System.
The client is responsible for the transmission of participants results through the interface activities within their own health information system.
Paper or electronic reports of a participant’s results include all required elements and information in compliance with and adherence to the College of American Pathologists (CAP) Laboratory General Checklist (CAP GEN. 41096), including the address of the reporting laboratory on the report.
In case, Lab Me partner labs changes a result or adds an additional comment to the original report, “Amended Report” will appear on top of the printed or electronic report. We will also notify the user immediately via the email used upon ordering a Lab Me test kit.
All amended reports will also be re-transmitted to the corresponding client. The report will show both the previous reported results and the amended or corrected results in compliance with and adherence to the CAP Laboratory General Checklist (CAP GEN. 41310).