Quick Tips

Reporting PT Results on Back-up Analyzers

Regulatory-If you have two non-waived analyzers that perform the same testing, you must perform proficiency testing on both analyzers. COLA requires their labs to report the proficiency testing results on the main instrument to the PT provider. You must perform a self evaluation using the same PT samples on the back up instrument. It is important to note that the PT samples must not be tested on the back up analyzer until after you have submitted the first instruments results to your PT provider.

Reporting Laboratory Injuries to OSHA

Operational-OSHA requires employers to track certain work place injuries such as splashes or needle sticks on OSHA 300 series logs. Currently these logs are kept on site and not sent to OSHA unless requested. Beginning January 2017, OSHA will require electronic submission of these forms annually. Employers with greater than 250 employees will submit form 300, 300A and 301. Employers with less staff will only need to submit form 300A. The injury data could be posted to the OSHA website.

Personnel Competency

In 2014 personnel competency assessment requirements were changed to ensure that employees can perform each task that they are assigned in a competent and correct manner following all written procedures and processes. These methods of competency review must include all of the processes in the pre-analytic, analytic and post-analytic phases of laboratory testing. Competency must be assessed by: direct observation of routine patient testing, monitoring the recording and reporting of patient test results, review of worksheets, quality control records, proficiency testing results, and preventive maintenance records, direct observation of the performance of maintenance and function checks, assessment of test performance through blind sample checks or previously tested specimens and an assessment of problem solving skills.

New Quality Control Lot

When evaluating a new control lot number for your instrument you must run testing in parallel with your old control lot number. In this way you confirm the new lot number of control is working appropriately. It is recommended that you run at least 20 values of each control; one set of normal and abnormal controls daily for 20 testing days. You must also confirm that the values recovered and established for your instrument are within the acceptable ranges listed on the manufacturer’s package insert for the control material.