Lab Services

Compliance Packages

1. CLIA Compliance Package (Basic)
1. Provide Required CLIA Compliance Policy Manual
2. Provide onsite training for implementation of CLIA Manual
3. Provide additional unlimited phone support after onsite visit
2. CLIA Compliance Package (Intermediate)
1. A second onsite visit within 60 days of first visit for review and evaluation of implementation of CLIA Manual
2. Directives for corrective actions where there are insufficiencies in implementing policies
3. Unlimited phone support through second onsite evaluation
3. CLIA Compliance Package (Advanced)
1. A third onsite visit around 90 days after initial training to review the successful implementation of the previous visits’ corrective actions and to insure consistent CLIA compliance
2. Unlimited phone support after the third onsite evaluation

Other Services

• CLIA Regulatory Review Service
  1. Perform a comprehensive regulatory compliance review
  2. Provide a written report of identified deficiencies with corrective actions
  3. Provide unlimited phone support after onsite review
• CLIA Inspections Service
  1. Review lab’s compliance before scheduled inspection to identify deficiencies
  2. Correct identified deficiencies
  3. Attend the inspection with/for you and provide any required corrective actions
• OSHA Annual Required Training & Documentation
• Monthly Scheduled Onsite QA Reviews
• OSHA Manual and Initial Required Training
• New Lab Set Up
  1. Linearity, correlation, & validity training
  2. Competencies of Employees
  3. Manuals for compliance, kit testing logs, and maintenance logs
  4. Review lab’s compliance before scheduled inspection to identify any deficiencies
  5. Correct identified deficiencies
  6. Attend the inspection with /for you and provide any corrective actions