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Labs in general can be very different depending on the number of specialties, ie. Chemistry, Hematology, Serology, Bacteriology, etc. Consulting services are accessed based on the specialties due to the intricacies of the test systems needed to meet compliance standards.
The goal of our consulting services is to educate and train you and your staff to be able to manage and perform laboratory testing in compliance with regulatory standards. In an effort to meet these goals, the Technical Consultant must teach and educate your staff on compliance issues including but not limited to the following:
- Personnel: requirements, education, and competency assessment
- Pre-Analytical policies and procedure
- Post-Analytical Policies
- Quality control procedures, troubleshooting and corrective actions
- Statistical analysis, Levy Jenning Graph review, and interpretation
- Validation studies and performance specs
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Proficiency Testing protocol, reporting, result analysis and remedial action
Quality Assurance procedures, implementation and assessment
Maintenance policies and procedures
Calibration and calibration verification
Laboratory Information systems review and validation (LIS)
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Services Offered
- Initial lab setup application process through inspection depending on state accrediting agency
- Pre-inspection Audit Review of all standards prior to inspection
- Technical Assistance off sight: Phone, fax, email
- Technical Consultant Designation per CLIA
- Periodic laboratory audits. Full review of lab compliance and training.
- Deficiency Response Post-inspection review and corrective actions
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Services