ATTESTATION STATEMENT OF QUALITY ASSESSMENT AND CONTROL
This facility has implemented and maintains a Quality Assessment Plan. The plan is designed to evaluate the quality of testing performed and to provide a system to identify and correct any problems detected. The laboratory director is responsible for the overall Quality Assessment Plan and for correction of any problems detected.
Problems identified by the plan will be documented along with the corrective action taken by the laboratory personnel and the laboratory director to correct them. The plan will be reviewed annually (at minimum) and revised as necessary, as determined by the laboratory director to accommodate any new procedures introduced to the test menu, or to detect any problems not addressed by the original Quality Assessment Plan.
All policies and procedures used by the laboratory have been approved by the laboratory director and are available, in writing, to the staff and to representatives of approved regulatory agencies.
QUALITY CONTROL (QC)
This laboratory has developed and maintains a Quality Control Plan to insure the reliability, accuracy and precision of test systems utilized by the laboratory and the test results produced by the laboratory. This laboratory uses and documents proper patient preparation, specimen collection identification and processing techniques. All procedures are available, in writing, to staff members and approved regulatory agencies. This laboratory performs and documents all instrument maintenance and calibration to insure the quality of instrument performance.This laboratory performs and documents an internal Quality Control Program to verify the reliability of the test system before patient samples are tested and identifies problems so they may be corrected before they affect patient test results. All documentation is reviewed by the laboratory director. Results are maintained for two years from the date the test was performed, and is available, upon request, for inspection by representatives of approved regulatory agencies.
This laboratory participates in an approved proficiency testing program to verify the consistency, accuracy, and quality of the test results produced by the laboratory. Corrective action is taken and documented as necessary, when indicated by proficiency test results. All documentation is kept on file for two years from the date test results were reviewed by laboratory director.
This laboratory provides continuing education for staff members to assure the continued quality of the laboratory and its compliance to federal and state regulations.
This laboratory has implemented and maintains a safety program to provide a safe and healthful work environment for the employees.
APPROVED BY: _______________________(Laboratory Director) DATE_______________
APPROVED BY: ________________________New laboratory Director) DATE_______________