White paper
Complete List of Support
OUR SERVICES
List of Major Services
1. Validation and Correlation Support
- Method to Method comparision
- Precision
- Linearities
- 6 month Linearities and cal verification
- Instrument to instrument correlation
- network correlations (Simple or Annova)
- Coagulation reagent crossover
- LDT validation
- Complete and submit Assay Modification Form for NYS
2. Qualilty Control Support
- Help Laboratories review and Submit QC data
- Monthly QC reviews
- Monthly QAP submission
- Setup Parallel Lots
- Setup Error budgets on New QC products as per CLIA and NYS
- Help Develop and Design IQCP as per the policies and standard
- Risk Assessment for IQCP based on local laboratory risk factors
- Identify and evaluate potential sources of error associated with the test process based on testing performed by a representative sampling of staff
- Setup Quality control plan for IQCP
- Setup Quality assessment plan for IQCP
- Help review and audit IQCP risk factors – annually
- Help Laboratories establish Quality indicators
- Monitoring specimen submissions, including compliance with test request requirements
- Timeliness and completeness for personnel training and competency
- QI performance on proficiency testing and alternative assessments of test accuracy and reliability;
- QI corrected test reports
- QI for turnaround times for urgent or STAT tests
- QI complaint investigations
- QI nonconformances
- Help Laboratories Monitors QI
- Biannual (or quarterly) QI monitoring
- Review data collection QI
- Review Data analysis for QI
- Review Acceptable performance and threshold for each indicator
- Action to be taken if QI do not meet defined expection including action that need notification to patients
3. PT survey related support
- Help select right PT product to participate in PT using primary method of analysis
- Performance review on the PT testing
- Select alternate assessment when PT testing is not available for a primary method
- Help to perform root cause analysis and investigate on a PT failure
- Help – implement and document corrective action if needed when unsatisfactory or unacceptable PT or alternative assessment result is identified.
- Help Identify impacted patient result based on RCA
- Help Notify clients when needed.
- Survey related Support – provide checklist
- Help find root cause analysis on deficiencies
- Help take necessary corrective action
4. Other Support
Other support provided by CLABIFY
- Review Analzyers monthly maintenance
- Making sure Biannual PM are done and documented
- FSR documented
- Monthly Lab Equipment temp review
- Monthly review of humidity
- Draft SOP
- Cost per test analysis
- MSD Sheet update
- Pipette calibration documentation
- Annual Platelet poor plasma verification
- Timer calibration by NST timer
- Review of microscope maintenance by engineer
- Review of Small equipment PM and Maintenance
- Review of completion of annual tech competencies
- Review of completion of annual procedures
- Review of nonconformances
- Draft Technical Bulletins for New procedure
- Review of Completion of annual OSHA by techs
- Review Annual HIPPA by Techs
- Review of CQ on all categories and PERMIT
- Review of organizational Chart
Please Read Terms of Services and Privacy Policies before using our services and platform. Local & International Laws Apply.
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.