Quality Clinical Laboratory Consultants offers consultation services that assure compliance with CLIA, COLA, and CAP. We also offer quality management programs for these accreditations. Our technical laboratory consultants can help physicians and staff overcome the challenges in starting and/or managing a laboratory. We offer consultation services including the following:

Administrative Package

  • CLIA start-up application, registration, certification

  • Enrollment of Proficiency Testing (PT)

  • Filing for State or Local Government License

  • Record preservation/maintenance/review

  • Addressing deficiencies/citations/corrective actions (CA)/reinstatements

  • Establishment/revision of policies/procedures/forms/worksheets

  • Evaluation of personnel credentials/qualifications

  • Development of Individualized Quality Control Plan (IQCP)

Proficiency Testing (PT) Package

  • Enrollment

  • Monitoring for successful participation/performance

  • Evaluation of PT performance/corrective actions (CA)/addressing deficiencies/citations

Accreditation

  • CLIA

  • COLA

  • JCAHO

  • CAP

 

Training & Competency Package

  • Laboratory personnel competency assessment

  • Credential/qualification auditing

  • Training/retraining

Validation/Calibration/ Quality Control (QC) Package

  • Establishment of verification of performance specifications

  • Maintenance and function check reviews

  • Review of quality controls/quality checks/quality systems

  • Comparison of results

  • Addressing corrective actions

Quality Assessment (QA)/Quality Systems Package

  • Ongoing review process for laboratory technical and non-technical functions

  • Monthly/quarterly review of control procedures, maintenance, corrective actions, communications, complaints, pre-analytical/analytical/post-analytical quality assessments

  • Managing all CLIA, State Regulatory & Accrediting Agency citations/deficiencies

 

Process Improvement Package

  • Employing Lean Processes

  • Monthly/quarterly suggestions, implementations, corrections, additions

We help with inspections, competency, handling corrective actions, any cited deficiencies, and CLIA Federal Regulation Compliance. We are also dedicated to helping physician office labs (POL) maintain compliance with CAP, COLA, State Regulations, and CLIA. Our members are medical technologists, experience as federal CLIA compliance officers and advanced degrees and extensive knowledge and experience in laboratories of different sizes and complexities. Our professionals are dedicated and truly committed to providing the services needed to maintain compliance.