Mandatory Citations - Part 2

There are four CLIA Condition level requirements that a surveyor must cite if non-compliance is found, regardless of the presence or absence of any negative outcome or potential harm.

The four CLIA Condition-level requirements are:

1. Proficiency testing enrollment – Standard 04.00.00
2. Proficiency testing referral – Standard 04.00.08
3. Unsuccessful proficiency testing participation – Standard 04.00.11
4. Issues related to personnel qualifications – Multiple standards within Chapter 2

The last issue of Did You Know? addressed proficiency testing enrollment and proficiency testing referral. This issue will address unsuccessful proficiency testing participation.

Proficiency testing (PT) is a window into the laboratory’s overall quality. Poor performance with PT can indicate systemic problems with competency, supervision, and management. PT problems can be an indicator of low reliability test results.

Standard 04.00.11 Successful Participation states:

Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA.

If a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte, or test, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions.

If a laboratory fails to perform successfully in a CMS-approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principal sanctions except when one or more of following conditions exist:

1. There is immediate jeopardy to patient health and safety.
2. The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance.
3. The laboratory has a poor compliance history

According to CLIA, unsuccessful participation is defined:

By Analyte: Unsatisfactory performance for the same analyte in two consecutive or two out of three testing events.

By Overall Testing Event: Unsatisfactory overall testing event scores for two consecutive or two of three testing events for the same specialty or subspecialty.

By Subspecialties not graded by analyte: Unsatisfactory testing event scores for the same subspecialty for two consecutive or two of three testing events.

If unsuccessful PT participation is the first occurrence for the laboratory and none of the exceptions listed in Standard 04.00.11 exist, the laboratory should conduct training of its personnel, seek technical assistance to correct the problem causing the unsuccessful participation, or both. HFAP will notify the laboratory that it must submit an acceptable plan of remedial action. The plan should include all corrective actions taken including all training and/or technical assistance efforts. The laboratory must demonstrate successful participation in the next PT event as verification that corrective actions were effective.

If the laboratory experiences unsuccessful participation a second time for an analyte, specialty, or subspecialty, the laboratory will be required to:

1. Cease testing for the specific analyte, specialty, or subspecialty. This cessation of testing is for 6 months.
2. Take appropriate corrective actions to ensure that the problem has been corrected.
3. Complete and submit the to HFAP.
4. Purchase and successfully perform two consecutive PT events (re-instatement PT).
5. Report the results of the two re-instatement PT events to HFAP.

Issues with proficiency testing should never be taken lightly. Every PT failure should be thoroughly investigated. Corrective actions taken should be comprehensive enough to ensure that the issue has been corrected. HFAP’s team of Laboratory Specialists is here to help should you need assistance. Contact us at info@HFAP.org.  

Additional information related to Proficiency Testing can be found at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAbrochure8.pdf  

Information from Laboratory Outreach Communication System (LOCS)

Updates from the FDA and CDC

FDA Approves First SARS-CoV-2 Assay

On March 17, 2021, the FDA issued a de novo classification order for BioFire Diagnostics, BioFire Respiratory Panel 2.1 (RP2.1) as a Class II device under the generic name “Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.” This is the first cleared, approved test for SARS-CoV-2.

For more information, please refer to the associated links below:

De novo letter: https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200031.pdf

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