CLIA regulations require proficiency testing on “regulated analytes”. These analytes are outlined under the proficiency testing section of the CLIA regulations. Proficiency testing for each regulated analyte is required three times a year. Samples must be tested in the same manner as patient samples and must be integrated with routing patient specimens. Typically, five proficiency testing samples are tested for each “testing event” and all five specimens should be tested by the same individual. However, CLIA requires proficiency testing to be rotated among all testing personnel. Therefore, one individual should test all five proficiency samples for one event, then a different individual should test all five samples during the next event. It may take several years for all testing personnel to perform proficiency testing in this manner.
Proficiency testing results are considered “satisfactory” if the laboratory scores 80% or better (with the exception of some immunohematology samples) for each analyte and each specialty or subspecialty. Any score below 80% is not acceptable and corrective action must be documented. Though a score of 80% or better is considered acceptable, any score less than 100% should be investigated and an attempt should be made to discover the cause of the less than perfect score. Be aware that two unsatisfactory results in a row, or two out of three unsatisfactory results will prompt a condition level deficiency and will result in a CMS-2567 “Statement of Deficiencies” report being mailed to the laboratory. This CMS-2567 is an official CLIA inspection report, even though an inspector did not present to the laboratory and perform a physical inspection.
According to the CLIA regulations, the laboratory must retain, for two years, all documentation associated with proficiency testing. This documentation includes: attestation statements (signed by the analyst performing the proficiency test and the laboratory director); instrument printouts; all worksheets used; and documentation of sample preparation. It is also recommended to retain a copy of the fax confirmation (if results are faxed) or the online confirmation (if results are reported online). In addition, if the laboratory sends results through the mail, it’s a good idea to send them certified mail to ensure they are received within the time frame prescribed by the proficiency testing company.
Laboratories must also be careful not to refer proficiency testing. Though a laboratory may routinely refer a patient specimen with an abnormal result to their reference laboratory, proficiency testing must not be treated this way. CLIA perceives this as “cheating” on proficiency testing challenges. In addition, laboratories must not converse with other laboratories regarding their proficiency testing results or send proficiency testing samples to another lab to “check” their own results. Another consideration should be testing personnel who either rotate between laboratories (as in the case of a reference lab) or personnel who work for two different laboratories. In this case, the person who either rotates or works in two different laboratories may not perform proficiency testing at both places because it would give the appearance of cheating on proficiency testing. When it comes to proficiency testing, laboratories should error on the side of caution because any appearance of cheating may result in fines, or even the loss of their CLIA certificate.
Not all analytes a laboratory may perform are regulated and subject to formal proficiency testing. CLIA still requires those “non-regulated” analytes to be verified twice annually. Some proficiency testing companies offer educational challenges for non-regulated analytes to meet this CLIA regulation. Another way to meet this regulation is to develop an exchange program with a nearby laboratory, or have two people in the same laboratory perform the same test on the same patient and document their results. Any discrepancy must be investigated and a corrective action documented.
It can be time consuming for a laboratory to ensure proficiency testing is routinely rotated amongst all testing personnel. All required documentation is completed and retained, and all results below 100% are investigated and corrective actions documented. Performing all of these tasks takes time away from patient care activities in physician offices. Let ProLab Consulting, LLC perform these tasks for your laboratory and give you more time to spend with your patients. We will ensure your lab is appropriately enrolled in proficiency testing, ensure samples are rotated in accordance with CLIA requirements, ensure all documentation is completed and retained, and assist in corrective action activities for all results less than 100%. We will prepare all corrective action documentation required by CLIA as well.