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Complete List of Support

OUR SERVICES

List of Major Services

1. Validation and Correlation Support

  1. Method to Method comparision
  2. Precision
  3. Linearities
  4. 6 month Linearities and cal verification 
  5. Instrument to instrument correlation
  6. network correlations (Simple or Annova)
  7. Coagulation reagent crossover
  8. LDT validation 
  9. Complete and submit Assay Modification Form for NYS 

2. Qualilty Control Support

  1. Help Laboratories review and Submit QC data
  2. Monthly QC reviews
  3. Monthly QAP submission
  4. Setup Parallel Lots
  5. Setup Error budgets on New QC products as per CLIA and NYS
  6. Help Develop and Design IQCP as per the policies and standard
  7. Risk Assessment for IQCP based on local laboratory risk factors
  8. Identify and evaluate potential sources of error associated with the test process based on testing performed by a representative sampling of staff
  9. Setup Quality control plan for IQCP
  10. Setup Quality assessment plan for IQCP
  11. Help review and audit IQCP risk factors – annually
  12. Help Laboratories establish Quality indicators
  13. Monitoring specimen submissions, including compliance with test request requirements
  14. Timeliness and completeness for personnel training and competency
  15. QI performance on proficiency testing and alternative assessments of test accuracy and reliability;
  16. QI corrected test reports 
  17. QI for  turnaround times for urgent or STAT tests
  18. QI complaint investigations
  19. QI nonconformances
  20. Help Laboratories Monitors QI
  21. Biannual (or quarterly) QI monitoring
  22. Review data collection QI
  23. Review Data analysis for QI
  24. Review Acceptable performance and threshold for each indicator
  25. Action to be taken if QI do not meet defined expection including action that need notification to patients

3. PT survey related support

  1. Help select right PT product to participate in PT using primary method of analysis
  2. Performance review on the PT testing
  3. Select alternate assessment when PT testing is not available for a primary method
  4. Help to perform root cause analysis and investigate on a PT failure
  5. Help – implement and document corrective action if needed when unsatisfactory or unacceptable PT or alternative assessment result is identified.
  6. Help Identify impacted patient result based on RCA
  7. Help Notify clients when needed.
  8. Survey related Support – provide checklist 
  9. Help find root cause analysis on deficiencies 
  10. Help take necessary corrective action 

4. Other Support

Other support provided by CLABIFY

  1. Review Analzyers monthly maintenance
  2. Making sure Biannual PM are done and documented
  3. FSR documented
  4. Monthly Lab Equipment temp review
  5. Monthly review of humidity
  6. Draft SOP
  7. Cost per test analysis
  8. MSD Sheet update
  9. Pipette calibration documentation
  10. Annual Platelet poor plasma verification
  11. Timer calibration by NST timer
  12. Review of microscope maintenance by engineer
  13. Review of Small equipment PM and Maintenance
  14. Review of completion of annual tech competencies
  15. Review of completion of annual procedures
  16. Review of nonconformances
  17. Draft Technical Bulletins for New procedure
  18. Review of Completion of annual OSHA by techs
  19. Review Annual HIPPA by Techs
  20. Review of CQ on all categories and PERMIT
  21. Review of organizational Chart

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Custom Services

We understand that Clinical Laboratories are unique and some of them have unique needs! Our services will be tailored to those unique needs whenever applicable.

All personal or remote works are done by NYS licenced medical laboratory technologist. 

Information!

All works performed by CLABIFY must be verified by site supervisor and directors as per, local and state and CLIA policies wherever applicable. This is an assistant program.

Contact

info@clabify.us

(607) 282-6484

PO Box 5700
Manlius, New York, 13037