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CLIA CERTIFICATIONThe Great Plains Laboratory, LLC is fully certified under the federal law of the United States of America called CLIA. In addition, all laboratories to which The Great Plains Laboratory, LLC sends samples are also CLIA certified. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. A laboratory is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, the impairment of, or assessment of health. Under the CLIA regulations, the federal Centers of Medicare and Medicaid Services will inspect any size laboratory for adherence to the CLIA requirements. However, if a state agency has an acceptable laboratory inspection program, then that state can perform the necessary laboratory inspections. If that laboratory complies with all of the quality control procedures, that laboratory is then awarded a CLIA license. The CLIA license means the laboratory has met all federal requirements for operating a laboratory. Other agencies including CAP, COLA, and JCAHO can also offer similar laboratory licensure programs but participation in such programs is not required. A copy of the current CLIA license of The Great Plains Laboratory, LLC is given below. PROFICIENCY TESTINGAll laboratories in the United States must comply, as required by law, with proficiency testing regulations for certain tests. Participation in proficiency testing for other tests is voluntary. Some labs participate while other labs do not. For example, The Great Plains Laboratory, LLC has voluntarily participated in the organic acid testing program (Biochemical Genetics) of the College of American Pathologists (CAP) since the inception of The Great Plains Laboratory, LLC in 1996. The Great Plains Laboratory, LLC participates voluntarily in all proficiency testing programs of the College of American Pathologists for which The Great Plains Laboratory, LLC offers testing. Many other laboratories do not perform this extra voluntary testing. The College of American Pathologists is a medical society serving nearly 16,000 physician members and the laboratory community throughout the world. It is the world's largest association composed exclusively of pathologists and is widely considered the leader in laboratory quality assurance. Approximately 23,000 laboratories throughout the world are enrolled in the proficiency testing programs of the CAP. The CAP Surveys is the largest laboratory peer comparison program in the world. 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 of their performance, as well as a report summarizing the results of all participating laboratories. INTERNAL QUALITY CONTROLIn addition to inspections by the state and participation in external proficiency testing programs of the CAP, The Great Plains Laboratory also has a strong internal quality control program in which portions of quality control samples are analyzed with every test batch to ensure laboratory quality. Also, patient samples are frequently split to make sure that different technologists perform similar work. FOOD AND DRUG ADMINISTRATION (FDA) APPROVALSThe FDA regulates companies that sell instruments and reagents to clinical testing laboratories. The Great Plains Laboratory, Inc. uses many FDA approved instruments and reagents. In some cases, there are no commercially available instruments or reagents. Such tests, termed “home brew” tests are regulated by the CLIA regulatory agencies. The FDA does not directly regulate clinical laboratories. This section introduces the process to attain KOLAS accreditation as conformity assessment bodies (CABs). ※ Conditions and required documents for application may vary according to Regulations of each accreditation scheme. Please refer to the Regulations of the applicable accreditation scheme. Application Eligibility for Accreditation Applicants ineligible for Application Required Documents (variance depending on accreditation schemes) - Application form for accreditation as a KOLAS accredited
CAB Calculation of
Application Costs and Payment ※ Assessment allowance shall be decided based on the fee applied to professional
technicians in accordance with the “criteria for engineering service fee” from Article 14 of the Enforcement ※ However, if KOLAS staff members or other government officials participate in the assessment as assessors, an applicant pays corresponding assessment fees (or document review fees) to the Korean Agency for Technology and Standards with government revenue stamps. Document Review Once corrective actions are taken for every supplementary request, an assessment team is formed and conducts on-site assessments to assess implementation of documented quality systems and its competence to carry out testing and to secure evidence required for accreditation decision. Assessments are made through interview, on-site
observation, witnessed assessment and review of relevant documents. Assessment Process: Establishment of an assessment plan → Notification of an on-site assessment plan (no later than seven days before the start of the assessment) → On-site assessment Deliberation of Committee The Accreditation Committee deliberates the appropriateness of assessment process and the applicant’s
competence as a testing laboratory. Notification Details of Notification: accreditation number, accreditation date, name of the KOLAS accredited CAB, business registration number, term of validity, fields and scope of accreditation Indication of Accreditation Term of Validity for KOLAS Accreditation Application Deadline for Reassessment: no later than seven months before the expiry Reporting Key Changes If the contents of the accreditation certificate have changed or the accreditation certificate has been lost or damaged, a KOLAS accredited CAB submits a request for the reissuance of the certificate to the Head of KOLAS with required documents. If a KOLAS accredited CAB voluntarily suspends or terminates its activities for more than six months, it is required to submit the Report on Voluntary Suspension (Termination) to the Head of KOLAS. In case of termination, it is required to return the accreditation certificate. If a KOLAS accredited CAB intends to resume activities after voluntary suspension, it is required to submit to the Head of KOLAS the evidence which shows reasons for voluntary suspension have been resolved. In such a case, the Head of KOLAS may, if he or she deems it necessary, conduct assessment to verify whether its quality systems and technical requirements continue to comply with the accreditation criteria. Surveillance Extraordinary Surveillance (Article 24, Paragraph 2 of the Regulations of each accreditation scheme) Which preanalytical factor that can affect validity of test results?Preanalytical factors that can affect results include: sample type, sampling time, sample handling, patient's preparation and the nutritional status of the patient.
What is the national organization that sets standards for phlebotomy procedures?Tools and more. What laboratory document describes in detail?A standard operating procedure (SOP) is a set of written instructions that describes, in detail, how to perform a laboratory process or experiment safely and effectively.
What is an example of a QC measure in phlebotomy?An example of a QC measure in phlebotomy is: Checking the expiration dates of evacuated tubes.
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