What Are the JCAHO Requirements for Pipette Verification in the Clinical Laboratory?

Calibration verification checks the reportable range as well as the dependability of an instrument's results. To maintain quality and consistency with laboratory instruments, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) enforces certain protocols adhered to by clinics and laboratories in hospitals and other clinical lab settings where samples are taken and/or experiments are conducted. According to Pipette Calibration Services (PCSI), a national pipette calibration and validation firm, clinical laboratories can take quality control steps to meet JCAHO requirements. The following recommendations---taken from the Joint Commission's Perspectives publication---are fully outlined at the PCSI website (see References).

Acceptable Materials and Performance

• Clinical labs may use either commercial linearity kits, or they may take a less expensive more convenient route and use information that is already available. This can be acquired by using a variety of materials with known values (national reference standards), calibrators, results from proficiency tests, or quality control lots. The lab must document three known samples (with low, middle and high values) that span the range.

Reporting Data

• The laboratory must then compile and prepare the data from these several times a year to show the instrument's performance and reportable range. If using a commercial test kit, the laboratory would then send the results to the vendor to be aggregated and analyzed.

Exceptions

• Bedside glucose testing, as well as other waived tests, do not require the data reporting. In these cases, the reportable range of the instrument should be validated before use, using quality control samples (high and low range) and/or known patient samples.