The Center for Disease Detection (CDD) is committed to providing accurate and timely results for every patient we serve. CDD achieves this objective through proactive implementation of rigorous quality control, quality assurance, lean management, process improvement, and performance monitoring procedures. QUALITY is our primary objective.
Leadership, Policies and Procedures
Quality control and assurance activities permeate every activity at CDD. Beginning at new-hire orientation, and including, but not limited to: implementation of new procedures, establishment of new accounts, implementation of new test methodologies, continuing education, process improvement and resolution of any potential issues.
Encompassing all business processes, CDD’s Quality Assurance Plan (QAP) has been designed and developed around pillars of quality, such as the College of American Pathologists (CAP), the Clinical Laboratory Standards Institute (CLSI), and International Organization for Standardization (ISO) 15189, to ensure the highest level of quality for large-scale diagnostic testing. Our plan incorporates US Food and Drug Administration (FDA), CAP, and Clinical Laboratory Improvement Act of 1988 (CLIA) requirements and excellent laboratory practices, and can be readily adapted to local requirements, as necessary. Our QAP encompasses the identification of deficiencies in the quality of services performed to ensure correction before performance becomes unsatisfactory, as well as activities to assure and verify confidence in the quality of the process.
CDD’s internal Quality Assurance/Quality Control (QA/QC) Committee represents a variety of specialized expertise in laboratory processes, workflow assessment, clinical biochemistry, pathology, clinical management, logistics, and procedural implementation and is the primary oversight body for all quality concerns including but not limited to new procedure implementation, potential quality control issues, development of preventive actions, implementation of any necessary corrective action, and follow-up.
Quality Control (QC) Mechanisms and Performance Monitoring
Internal and External Audits are two primary devices in our toolkit for ensuring state-of-the-art diagnostic testing.
CDD conducts periodic internal audit inspections, based on CAP guidelines, federal CLIA and state regulations. Our Quality Assurance (QA) Committee reviews the results of internal audits monthly. Any issues noted during previous inspections are reviewed to make sure they have been appropriately addressed. These inspections include:
- Document and Record Reviews. Document reviews ensure that procedures and manuals are complete, current, and available to staff. All standard operating procedures (SOPs) are reviewed at least annually for content and adherence to excellent laboratory practices. CDD also performs a comprehensive records review, inclusive of QC and proficiency testing records, instrument maintenance records, and method performance validations.
- Technician Observation. Periodic observations of lab technologist performance of duties and comprehensive competency evaluations for all laboratory personnel. Actual performance is compared to written policies and procedures, and discrepancies are documented.
- QC and Peer Review in Cytology and Pathology. All cytologists and pathologists undergo a minimum QC of daily work. Additionally, pathologists’ diagnoses are routed for peer review weekly.
- Specimen Follow-Through. By following a specimen from receipt through test result, all process areas (pre-analytical to post-analytical) are evaluated. Factors considered during these reviews include accurate identification of patients and specimens, timely accessioning and result reporting, proper retention of test records, and confidentiality of patient data.
- Review of Performance Indicators. Key quality indicators are monitored, both through direct observation and document review.
- Internal Quality Control (Laboratory Proficiency Testing). QC material is available for all procedures and reflects all ranges of reportable values. Both internal and external proficiency testing programs are utilized. Internal QC is performed on every testing batch. Patient results are not released until identified discrepancies are corrected.
External Audits and Proficiency testing are an integral component of CDD’s QC/QA Program. CDD participates in proficiency testing from CAP, US Department of Defense, New York State and the American Association of Bioanalysts. CDD’s processes have been audited by third party Lean Six Sigma black belts to ensure elimination of the seven kinds of wastes (Defects, Overproduction, Transportation, Waiting, Inventory, Motion and Over-Processing). CDD is frequently audited by third party organizations such as CAP, Centers for Medicare & Medicaid Services (CMS), New York, California, the US Navy and the US Army to ensure a constant high level of quality.
CDD Quality Assurance personnel remain current on the latest quality control and process assessment tools, and proactively implement procedural improvements, as deemed appropriate by our QA/QC Committee.
Questions or Additional Information on CAP Accreditation, Proficiency Testing, Laboratory Improvements, and Quality Standards is accessible from: The College of American Pathologists.
Information on CLIA is accessible from: The Center for Disease Control and Prevention
Information on CLSI standards is available from: Clinical and Laboratory Standards Institute (CLSI)
Information on ISO 15189 is available from:
- International Organization for Standardization
- The College of American Pathologists
- The American Association for Laboratory Accreditation (A2LA)
For additional information on CDD’s quality control, quality assurance, or performance monitoring procedures, please contact: firstname.lastname@example.org.