Esoterix maintains a comprehensive Quality Assurance Program that ensures the highest quality standards for all laboratory services and promotes continuous improvement throughout the company. An M.D. or Ph.D. level scientist manages each laboratory section at Esoterix. Through our Center for Innovation, Esoterix researches and develops new assays and technologies to continually improve the quality of patient results. All Esoterix facilities retain required licensures, are active in several proficiency testing programs, including the College of American Pathologists, and allow frequent FDA quality inspections to meet the stringent requirements of our Clinical Trials customers.

Quality Assurance Program
Our Quality Assurance Program is designed to consistently meet or exceed the expectation of our customers, regulatory agencies, and internal Esoterix quality standards. The Quality Assurance Program covers all aspects of laboratory testing from pre-analytic, analytic, to post-analytic. All of Esoterix's laboratory sites operate independent QA/QC programs and participate in the overall company wide QA program under the guidance of the Esoterix Quality Assurance Team. The cumulative effect of this policy ensures accurate, timely reporting of results, competency of the staff, and provides statistical evidence of Continuous Quality Improvement (CQI).

The following information outlines the procedures involved in monitoring our quality assurance and identifying opportunities for improvement.

Quality Assurance Program Objectives

• Maintain an appropriate technical quality control program for all standard operating procedures, with regular and timely documentation and review of quality control (QC) records
• Maintain accreditation and licensure within the appropriate states, the College of American Pathologists, CLIA, and other agencies involved in laboratory regulation
• Enhance expertise of technical personnel by monitoring certification requirements, and by developing and maintaining a continuing education program for all employees
• Carry out a successful preventative maintenance program for all equipment
• Provide a safe workplace through coordination with laboratory safety programs
• Ensure the quality, accuracy, and timeliness of processing and reporting functions as major considerations toward optimal medical laboratory service to physicians and their patients
• Maintain a system for evaluation of all aspects of lab operations and identify areas for enhancement

Quality Assurance Program Elements
Patient Test Management
Esoterix follows proper written authorization prior to performance of test analysis on patient samples. Requisition forms are sent along with the specimens. Added tests or specimens without a request form are authorized via telephone with a follow-up, faxed request form.

Specimens are collected, transported, and stored at appropriate temperature for analysis when under our control. Complete instructions for proper collection, storage, and transport are available under the collection and courier services section of this website. Esoterix's unified LIS and bar-coding system aid in the tracking and documentation of all specimens. A comprehensive set of SOPs cover all aspects of testing and reporting of results.

Quality Control
Normal and abnormal levels of quality control material are tested with each run. For assays without established control guidelines, appropriate controls are run to establish the quality of the assay. QC results are analyzed daily before patient results are reported, ensuring precision and accuracy throughout the run. QC records and patient results are also monitored continuously for trends, shifts, and means and further reviewed monthly by the QA team.

A general policy regarding reagent QC is maintained in each laboratory. Each laboratory site establishes a reagent QC program that monitors the following parameters:

• Use of reagent within expiration date
• Maintenance of integrity and proper storage
• Preparation and date-in-use proper documentation
• Accurate procedures for preparation
• Performance specifications and documentation of evaluation prior to use
• Monthly review of documentation
• Archival documentation

Instrumentation
All instruments are maintained according to manufacturer's guidelines. Validation and calibration procedures are performed prior to instruments being placed into service and are approved by the Laboratory Director or designee with documentation. Maintenance records, both preventative and unscheduled, are documented for each instrument with permanent records maintained for the life of the instrument.

Correlations studies between instruments performing the same or similar tests, especially backup instruments, are performed at least twice a year. These results are documented and reviewed by the Laboratory Director.

The Laboratory Director, or designee, reviews all QA records each month. Any out-of- specification results, along with the appropriate corrective action, are discussed at QA meetings.

Proficiency Programs
All departments participate in CLIA-approved proficiency programs. Specialized tests not covered by a CLIA approved program are exchanged with another laboratory twice per year. In-house blind samples, which are treated in the same manner as actual patient samples, are also used to test the competency of technologists. A rotation schedule of performance, analysis, and reporting is maintained to assure each employee is assessed for performance.

Laboratory Inspections and License
State Licensing Agencies if appropriate, CLIA, the College of American Pathologists, and the New York State Laboratory Licensing Agency (NYS) currently inspect Esoterix's laboratory facilities. A CAP inspection is used in combination with the State inspection if appropriate. The results of the CAP inspection are released to CLIA and the respective state. Every alternate year a CAP self-inspection will occur in lieu of an on-site inspection. In addition, NYS has an on-site inspection bi-annually for licensed locations. Results of these inspections are reported in the Esoterix Board of Directors Compliance Report.

Esoterix maintains good standing with CLIA regulations and each respective state. Any state license required for client work is maintained. A CAP inspection, with corrections of deficiencies, is used as a standard performance evaluation. Copies of current licenses and license numbers are available at the client's request.

Permits and licenses are held from the states of Maryland, Florida, Pennsylvania, California, New York, and Rhode Island, along with CAP and CLIA. Various audit teams for continued compliance with GLP and GMP regulations also perform on-site inspections. Safety audits are performed on an annual basis to assure compliance with the Esoterix Safety Program and all OSHA regulations.

Personnel
The Esoterix Quality Policy is a key element of evaluation for all employees. Quality objectives are established for each employee and they are held accountable on an annual basis. Esoterix ensures all staff members meet or exceed all required qualifications and requirements according to CLIA and the states in which they are employed. A Ph.D. or M.D. level scientist manages each laboratory section and all supervisors are staffed according to federal and/or state regulation. Organizational charts and staff biographies are available upon client request.

Safety Program
This program is outlined in the Esoterix Safety Manual and is designed to provide the safest working environment possible for the employees of Esoterix. All regulations pertaining to lab safety and universal precautions are followed. The program educates and maintains records of employee drills and safety workshops, ensuring that policies are being enforced and that all possible issues are addressed in a pertinent and timely manner.

Record Retention
All records and documentation, both electronic and paper, are kept, minimally, for the required period of time. If one regulation differs from another in the length of time, the laboratory will comply with the regulation that requires the greatest period of time. These records include patient results as well as quality assurance records.

Continuous Quality Improvement
The three major areas of assessment for quality improvement are product quality (reported results), customer satisfaction (quality of reporting, turnaround time, client retention), and personnel qualification. Any client or employee comment or suggestion related to standard operating procedures, assay methodologies, or system improvements are reported as continued quality improvement. In addition, key indicators are reported and reviewed monthly by the QA Team as well as Esoterix's Senior Management. Opportunities for improvement are prioritized and corrective action is documented and monitored for improvement implementation in a timely manner.