Presenters at the 13th Annual Lab Quality Confab 2019 discussed the negative impact of disparities between medical laboratory processes and SOPs

ATLANTA, Oct. 18, 2019—Several weeks ago, the Centers for Medicare and Medicaid Services (CMS) quietly released QSO-19-20-CLIA: Revisions to State Operations Manual (SOM), Chapter 6—Special Procedures for Laboratories. The release, which went to all State Survey Agency Directors, includes a “comprehensive revision to establish quality laboratory policies and procedures to ensure accurate and reliable test results to protect patients and improve the quality of healthcare,” CMS’ website states.

The revisions went into effect September 26, 2019.

Clinical laboratory consultant Linda Flynn, Principal of LS Flynn and Associates, said “I find [the CMS release] very helpful because it can put you in the CMS inspector’s head—it offers a lot of insight.” Flynn highlighted QSO-19-20-CLIA during her breakout session, “Understanding the True Cost of Bad Quality, Both in Your Lab and Throughout Your Parent Hospital or Health Network,” at The Dark Report’s 13th Annual Lab Quality Confab (LQC) in Atlanta.

For clinical laboratory administrators, managers, and quality team members, reviewing the Special Procedures for Laboratories is worth the effort as part of your 2020 lab quality program and continuous improvement efforts. CMS made it easy to see what has changed by highlighting the revisions in red.

One revision worth noting is 6006.4–Certificate of Compliance, which has been revised to say, “A Certificate of Compliance is issued to a laboratory after an inspection finds the laboratory to be in compliance with all applicable requirements.”

CMS Stepping Up Scrutiny, Particularly in Preanalytical Phase

Laboratories that deviate practices and processes from their standard operating policies and procedures (SOPs) are going to get dinged, Flynn explained during her session. Some examples recommended for review included:

  • Validating specimen types, initially and as part of a change in a major component;
  • Showing that temperature is properly controlled during specimen transport; and
  • Mitigating risks as part of the shift to more nurse-drawn specimens.

Additionally, Flynn noted that addressing deficiency citations, deficiency practice related survey data tags (D-Tags), and Form CMS-2567 (Statement of Deficiencies and Plan of Correction) are all daunting and complex. Many D-Tags have multiple regulatory requirements, according to CMS.

During her breakout session at The Dark Report’s 13th Annual Lab Quality Confab in Atlanta, Linda Flynn (above), Principal of LS Flynn and Associates, explained that the rigors of a CMS inspection far exceed those of other inspectors. “This is digging,” she stressed, adding that a CMS inspection comes with a big team of career inspectors. “It’s almost punitive … they know what they are looking for.” (Photo copyright: The Dark Report.)

Are Medical Laboratories at Risk for Factors They Cannot Control?

Several attendees pointed out that in certain scenarios, specimen jeopardy and patient risk are out of the medical laboratory’s control. Nevertheless, Flynn says the laboratory is still responsible.

In addition to how a failure can adversely affect a patient, the cost of failures can run into the millions of dollars which are attributed to legal fees, consulting, staff overtime, and sanctions for the laboratory, she said.

To reduce risk, Flynn recommends that medical laboratory management address the complete lab continuum by getting out of the lab and interfacing with people outside the lab who may adversely affect specimens.

Lessons Learned Through Health System’s Policy Standardization Project

There are lessons to be learned from health systems that seek to standardize compliance and policies, explained Debra Zern, Director of Laboratory Quality and Internal Process Control at Intermountain Healthcare in Utah, during her LQC session, “Let’s Talk Process! Identifying and Communicating Best Practice Ideas Across Multiple Lab Sites to Standardize Compliance and Policies while Creating a Shared Culture.”

Intermountain generates approximately 10 million laboratory tests per month, according to Zern. However, years ago, the health system’s laboratories were not standardized at all. They were individually managed, they had been writing unique SOPs, they were purchasing their own equipment, and their vendor contracts were facility specific.

To standardize the labs, 11 discipline-specific practice councils (work groups) were developed, each including representatives from rural and core laboratory sites.

“What we found is that there is a lot of personal attachment to SOPs,” Zern said. “As a team, we came up with better wording than we did as individuals.” The end product was a single SOP, developed with the oversight of medical directors and workable for everyone.

Clinical laboratory administrators, managers, and quality team members learned much at this year’s LQC. If you were unable to attend Lab Quality Confab this year, the digital audio recording series of 41 presentations is available for purchase. Go to for more information.

—Liz Carey

Related Information:

Downloadable PDF: QSO-19-20-CLIA-Revisions to State Operations Manual (SOM), Chapter 6-Special Procedures for Laboratories

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