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Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Anatomic Pathologists Who Work in Independent Reference Laboratories Can Now Provide Diagnostic Services for CLIA-Approved Hospitals without Need for Additional Credentialing and Privileging

The Joint Commission’s recent alteration to the Introduction to Leadership (LD) Standard LD.04.03.09 makes it easier for off-site and independent reference laboratories to service CLIA-hospitals and other CLIA-approved healthcare facilities

Anatomic pathologists working for reference laboratories can now provide diagnostic services to hospitals, critical-access hospitals, and ambulatory care facilities in the US based on the organization’s Clinical Laboratory Improvement Amendments (CLIA) status, rather than the usual credentialing and privileging. The Joint Commission (TJC) made the change effective January 2018.

According to a TJC press release, “Clinical Laboratory Improvement Amendments (CLIA) regulations 42 CFR 493.1351 through 493.1495 outline specific and rigorous competency requirements for laboratory personnel, including requirements for pathology services and its subspecialties. But because pathologists practicing in the US are required to comply with these requirements, Joint Commission-accredited organizations that seek the services of pathologists within independent reference laboratories (that comply with CLIA regulations) can safely presume that the pathologists are qualified and competent to perform all diagnostic services within their pathology practice—thus making an additional credentialing and privileging process unnecessary.”

In an interview with Dark Daily, Heather Hurley, Executive Director, The Joint Commission, and Ron Quicho, Associate Project Director and Standards Development Director at TJC, explained the reasons behind this change. “With the current CLIA requirements, the previous standard was adding unnecessary burdens and regulatory overhead to hospitals and ambulatory care organizations—especially as outsourcing continues to increase within the testing market. This update helps to reduce these burdens and streamline testing,” Hurley noted.

Quicho added, “The Joint Commission continually evaluates its standards and survey process to ensure that we are providing an accreditation service that is of the highest quality and value. That said, we made the decision to update the standards based on feedback from stakeholders and customers.”


Ron Quicho, Associate Project Director and Standards Development Director (left), and Heather Hurley, Executive Director (right), The Joint Commission, believe these updated standards will benefit clinical laboratories and hospitals alike. But they note, “Anytime the pathologist provides professional services and consultation in the same laboratory where the specimen was collected or prepared, credentialing and privileging would be required. The exception for credentialing and privileging only applies when pathology services are provided off-site, such as at a reference laboratory.” (Photo copyrights: LinkedIn/The Joint Commission.)

Joint Commission Reduces ‘Unnecessary Burden’ on Hospitals, Ambulatory Care Facilities

Reference testing and CLIA have been a common part of the diagnostics and medical laboratory landscape for decades. According to Quicho, the key components of The Joint Commission’s decision include:

  • Increasing numbers of independent practitioners and consultants;
  • Reference laboratories often seek pathology services from another laboratory for certain testing and screening. As such, it is unclear if the credentialing and privileging requirements extend to these secondary pathology services, since they may also be providing the interpretation;
  • It would be virtually impossible to credential and privilege all pathologists at a reference laboratory whose services result in patient care decisions, since interpretations are made not only in anatomical (surgical) pathology but in many areas of clinical pathology; and,
  • Reference laboratories employ hundreds of pathologists and healthcare facilities and cannot be sure of who provides interpretation on specimens that are sent out.

It is important to understand that the exclusions in this latest TJC update only apply when testing is performed offsite of the ordering facility. In their press release, TJC stated, “A reference laboratory is a laboratory contracted for testing that is owned and operated by an organization other than the organization referring the testing … When the pathologist provides his or her professional service, including consultation in the same laboratory or organization where the specimen was collected or prepared, credentialing and privileging is required.”

TJC Change Helps Clinical Laboratories and Hospitals Alike

Hurley points out that the January 2018 edition of TJC’s “Comprehensive Accreditation Manuals” already includes the updated standard and that participating ambulatory care, critical access hospitals, and hospitals were updated regarding the changes. The 2018 print editions will also include this change.

She also points out that exclusion from the standard’s requirements does not prevent hospitals from still requiring credentialing or privileging for their internal compliance processes or regulations. Quicho also emphasizes the importance of continuing to meet all CLIA requirements surrounding competencies, training, and personnel qualifications.

The TJC update should result in less action required by both clinical laboratories and hospitals alike—a welcome change for a market in a state of near-constant flux due to healthcare reform and increased regulation. The reasoning behind the decision also highlights current trends amongst pathology groups and clinical laboratories concerning scaling through consolidation and outsourcing among hospitals, ambulatory care organizations, and critical care providers.

—Jon Stone

Related Information:

Now in Effect: Change to Requirements for Credentialing, Privileging of Independent Pathologists

Credentialing and Privileging of Independent Pathologists

The Joint Commission No Longer Requires Credentialing and Privileging of Independent Pathologists—Four Things to Know