Information from Laboratory Outreach Communication System (LOCS)

Mandatory Citations

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.

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

Previous issues of Did You Know? have addressed the first three CLIA condition-level requirements that must be cited if non-compliance is found. This issue will address the last: Issues related to personnel qualifications.

Personnel requirements are determined by the complexity or level of the testing performed in the laboratory. If the laboratory performs any testing classified as high complexity, the laboratory must meet all the CLIA personnel requirements (qualifications and responsibilities) for the positions listed for a high complexity laboratory.

In both high complexity and moderate complexity laboratories, an individual may hold more than one CLIA-defined position if the individual meets the qualifications for each position.  Each laboratory must define who fills each CLIA required position.

High Complexity Laboratory Positions

• Laboratory Director
• Technical Supervisor (for each applicable specialty/subspecialty)
• Clinical Consultant
• General Supervisor
• Testing Personnel
• Cytology General Supervisor (only if Gynecologic and/or Non-Gynecologic cytology testing is performed)
• Cytotechnologists (only if Gynecologic and/or Non-Gynecologic cytology testing is performed)

Moderate Complexity Laboratory Positions

• Laboratory Director
• Technical Consultant
• Clinical Consultant
• Testing Personnel

During the on-site survey, laboratory surveyors will evaluate the qualifications for the individuals designated as filling these roles. Information on qualification requirements for each position can be found in Chapter 2 of HFAP’s Accreditation Requirements for Clinical Laboratories.

Condition-level deficiencies will be cited for each of the CLIA required positions if

• The position is not filled.
• The individual is not qualified.
• The individual does not fulfill the responsibilities of the position.

To avoid condition-level deficiencies related to personnel:

1. Develop a document that lists who fills each CLIA-required position.
2. Review everyone’s qualifications against those required by CLIA.
3. Have documentation to demonstrate qualifications available at the time of the survey. This documentation includes transcripts, diplomas, and/or primary source verification of state licensure.
4. Ensure that each designated individual is meeting the responsibilities of the position(s) that they hold.

Any questions related to this topic or any other laboratory issue can be sent to info@hfap.org. We’re here to help your laboratory excel!

Laboratory Information Management System (LIMS)

On May 10, 2021 the CDC announced the release of a new, basic-level eLearning course that provides an overview of the Laboratory Information Management System (LIMS) and other information systems that play a key role in laboratory informatics. This course is designed for public health and clinical laboratory staff (including managers and leaders) and other persons interested in the role and importance of LIMS to the operation of the laboratory. 

This course includes: 

• Explorations of LIMS functionality 
• The role of the LIMS in interoperability 
• Regulations and standards regarding information systems and laboratory data 
• Steps to implement a LIMS 

This course is approved for 1.5 contact hours of P.A.C.E.® credit. 

SARS-CoV-2 Variants of Interest

On May 4, 2021, the CDC, in coordination with the SARS-CoV-2 Interagency Group (SIG), classified SARS-CoV-2 variants B.1.617, B.1.617.1, B.1.617.2, and B.1.617.3 as variants of interest. B.1.617.3 was first detected in India in October 2020; B.1.617.1 and B.1.617.2 were first detected in India in December 2020, and B.1.617 was first detected in India in February 2021. Investigations are underway to further characterize additional B.1.617 lineage viruses and their potential impact on current tests, vaccines, and therapeutics.

SARS-CoV-2 variants can be categorized into the following three classes based on a Variant Classification scheme developed by a U.S. government interagency group:

• Variant of Interest
• Variant of Concern
• Variant of High Consequence

A variant of interest might require one or more appropriate public health actions, including

• Enhanced sequence surveillance
• Enhanced laboratory characterization
• Epidemiological investigations to assess how easily the virus spreads to others, the severity of disease, the risk of reinfection, and whether currently authorized vaccines offer protection

Want to learn more about HFAP Laboratory Accreditation?
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ACHC Launches New Podcast

ACHC introduces Beyond the Standard, a podcast exploring ideas in healthcare. On the first episode, we’re looking at the importance of culture in initiating the recent historic merger of two nationally recognized healthcare accreditation organizations. New episodes will be released monthly. For more and to access the episode, see below.