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Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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What Key Laboratory Leaders Will Learn at This Week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management

Executives and pathologists from many of the nation’s most prominent clinical laboratories are on their way to the Crescent City today to share best practices, hear case studies from innovative labs, and network

NEW ORLEANS—This afternoon, more than 900 lab CEOs, administrators, and pathologists will convene for the 28th Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management conference. Three topics of great interest will center around adequate lab staffing, effective cost management, and developing new sources of lab testing revenue.

Important sessions will also address the explosion in next-generation sequencing and genetic testing, proposed FDA regulation of laboratory-developed tests (LDTs), and innovative ways that clinical laboratories and pathology groups can add value and be paid for that additional value.

All this is happening amidst important changes to healthcare and medicine in the United States. “Today, the US healthcare system is transforming itself at a steady pace,” explained Robert L. Michel, Editor-in-Chief of The Dark Report and Founder of the Executive War College. “Big multi-hospital health systems are merging with each other, and payers are slashing reimbursement for many medical lab tests, even as healthcare consumers want direct access to clinical laboratory tests and the full record of their lab test history.

“Each of these developments has major implications in how clinical laboratories serve their parent organizations, offer services directly to consumers, and negotiate with payers for fair reimbursement as in-network providers,” Michel added. “Attending the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management equips lab leaders with the tools they’ll need to make smart decisions during these challenging times.”

Executive War College

Now in its 28th year, the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management convenes April 25-26 in New Orleans. Executive War College extends to a third day with three full-day workshops: LEAN fundamentals for lab leaders, a genetic testing program track, and a digital pathology track. Learn more at (Photo copyright: The Dark Intelligence Group.)

Challenges and Opportunities for Clinical Laboratories

With major changes unfolding in the delivery and reimbursement of clinical services, clinical laboratory and pathology practice leaders need effective ways to respond to the evolving needs of physicians, patients, and payers. As The Dark Report has often covered, three overlapping areas are a source of tension and financial pressure for labs:

  • Day-to-day pressures to manage costs in the clinical laboratory or pathology practice.
  • The growing demand for genetic testing, accompanied by reimbursement challenges.
  • Evolving consumer expectations in how they receive medical care and interact with providers.

Addressing all three issues and much more, the 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management features more than 80 sessions with up to 125 lab managers, consultants, vendors, and in vitro diagnostic (IVD) experts as speakers and panelists.

Old-School Lab Rules Have Evolved into New-School Lab Rules

Tuesday’s keynote general sessions (to be reported exclusively in Wednesday’s Dark Daily ebriefing) will include four points of interest for clinical laboratory and pathology leaders who are managing change and pursuing new opportunities:

  • Positioning the lab to prosper by serving healthcare’s new consumers, new care models, new payment models, and more, with Michel at the podium.
  • How old-school lab rules have evolved into new-school lab rules and ways to transition the lab through today’s disrupters in healthcare and the clinical laboratory marketplace, with Stan Schofield, Managing Principal of the Compass Group.
  • The growing trend of clinical laboratory-pharmacy relationships with David Pope, PharmD, CDE, Chief Pharmacy Officer at OmniSYS, XIFIN Pharmacy Solutions.
  • Generating value by identifying risk signals in longitudinal lab data and opportunities in big data from payers, physicians, pharma, and bioresearch, with Brad Bostic, Chairman and CEO of hc1.

Wednesday’s keynote sessions (see exclusive insights in Friday’s Dark Daily ebriefing) explore:

Wednesday’s keynotes conclude with a panel discussion on delivering value to physicians, patients, and payers with lab testing services.

Clinical Labs, Payers, and Health Plans Swamped by Genetic Test Claims

Attendees of the 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management may notice a greater emphasis on whole genome sequencing and genetic testing this year.

As regular coverage and analysis in The Dark Report has pointed out, clinical laboratories, payers, and health plans face challenges with the explosion of genetic testing. Several Executive War College Master Classes will explore critical management issues of genetic and genomic testing, including laboratory benefit management programs, coverage decisions, payer relations, and best coding practices, as well as genetic test stewardship.

This year’s Executive War College also devotes a one-day intensive session on how community hospitals and local labs can set up and offer genetic tests and next-generation sequencing services. This third-day track features more than a dozen experts including:

During these sessions, attendees will be introduced to “dry labs” and “virtual CLIA labs.” These new terms differentiate the two organizations that process genetic data generated by “wet labs,” annotate it, and provide analysis and interpretation for referring physicians.

State of the Industry: Clinical Lab, Private Practice Pathology, Genetic Testing, IVD, and More

For lab consultants, executives, and directors interested in state-of-the-industry Q/A and discussions concerning commercial laboratories, private-practice pathology, and in vitro diagnostics companies, a range of breakout sessions, panels, and roundtables will cover:

  • Action steps to protect pathologists’ income and boost practice revenue.
  • Important developments in laboratory legal, regulatory, and compliance requirements.
  • New developments in clinical laboratory certification and accreditation, including the most common deficiencies and how to reach “assessment ready” status.
  • An update on the IVD industry and what’s working in today’s post-pandemic market for lab vendors and their customers.
  • Federal government updates on issues of concern to clinical laboratories, including PAMA, the VALID Act, and more.

Long-time attendees will notice the inclusion of “Diagnostics” into the Executive War College moniker. It’s an important addition, Michel explained for Dark Daily.

“In the recent past, ‘clinical laboratory’ and ‘anatomic pathology’ were terms that sufficiently described the profession of laboratory medicine,” he noted. “However, a subtle but significant change has occurred in recent years. The term ‘diagnostics’ has become a common description for medical testing, along with other diagnostic areas such as radiology and imaging.”

Key managers of medical laboratories, pathology groups, and in vitro diagnostics have much to gain from attending the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, now in its 28th year. Look for continued coverage through social media channels, at Dark Daily, and in The Dark Report.

Clinical laboratories are invited to continue the conversations by joining the Executive War College Discussion Group and The Dark Report Discussion Group on LinkedIn.

Liz Carey

Related Information:

Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management Agenda

Six Important Themes to Help Labs Succeed

Executive War College Press

The Dark Report

Dark Daily eBriefings

The Dark Report Discussion Group

Executive War College Discussion Group

Sarasota Memorial Health Care Implements Specimen Processing Automation in Its Microbiology Laboratory During Early Days of the COVID-19 Pandemic

While working to increase turn-around-times for STAT tests, Florida’s first coronavirus patient arrived, requiring SMH’s clinical laboratory team to adapt its plans

Despite the COVID-19 pandemic, the clinical laboratory team at 839-bed Sarasota Memorial Hospital, part of the Sarasota Memorial Health Care System (SMH) in Sarasota, Fla., not only implemented a new automated microbiology system, it also installed a new mass spectrometry analyzer, along with new instruments to support large volumes of SARS-CoV-2 testing.

How SMH’s microbiology laboratory team accomplished this while shelter-in-place directives in Florida caused many patients to stop visiting emergency departments and physicians’ offices—and as hospitals and medical laboratory facilities restricted access to staff and essential personnel—provides useful lessons for pathologists and clinical laboratory managers.

Bad Timing for a Pandemic

“The early weeks of the pandemic hit just as we were beginning the phased installation of our COPAN WASPLab microbiology automation this summer,” said Harold Vore, MS, MT(ASCP), Director of Laboratory Services at SMH, in an exclusive interview with Dark Daily’s sister publication, The Dark Report (TDR), for an article titled, “Sarasota Hospital Lab Reduces Number of Hemolyzed Specimens: Lean Improvement Project Saves $3.5 Million.”

“Florida reported its first positive SARS-CoV-2 infection on March 2, marking the beginning of an outbreak that continues today,” he noted, adding, “This created the need to support the hospital in identifying infected patients in Sarasota County by having the microbiology lab acquire and set up more instruments. Also, the micro lab needed space for a new mass spectrometry analyzer to speed up pathogen identification this year.

In the same TDR interview, Olevia Fulkert, Microbiology Technical Supervisor at SMH said the microbiology lab had to reconfigure its layout to be prepared for the new COPAN system. “Our team had to arrange space for these new instruments, while protecting the space needed for the microbiology automation.”

“The WASPLab (above) literally went right into the middle of the busiest area of our lab,” said SMH’s Director of Laboratory Services, Harold Vore, MS, MT. “That’s the room we call COVID central, because that’s where we process all SARS-CoV-2 specimens.” SMH’s medical laboratory team began this implementation in the early months of the COVID-19 pandemic and relied on Lean processes to accomplish its goals. (Photo copyright: Sarasota Memorial Health Care System.)

Return of the ‘Snowbirds’

In August, SMH’s microbiology laboratory staff was busy validating the WASPLab instruments so the lab would be ready to process patient specimens when Florida’s snowbirds—out-of-state residents who arrive for the winter—return to Sarasota.

Vore knew several elements would be required for SMH’s microbiology automation project to succeed:

  • He had to assure the microbiology lab’s staff that adding automation would not cause any loss of jobs.
  • Timing of the implementation was critical, because lab test volume rises in the winter when tourists and part-time residents return.
  • Lean methods would be important because lab staff was familiar with them and they would help the vendor to arrange the physical layout and workflow to optimize productivity, reduce errors, and decrease turnaround times.
  • Vore needed documentation that showed automating the microbiology lab met and exceeded the return-on-investment projections he and his lab team used to persuade health system administrators of its value.

According to Vore, to date the installation has gone smoothly. “The staff in the microbiology lab has been phenomenal,” he commented. “They have continued to do what they always do, while at the same time we’re installing this large new system right in their midst.

“And they did not complain. In fact, they were eager to make progress in improving production,” he continued. “That attitude is common among our laboratory staff, because we saw the same thing happen when we automated our core lab.”

Increasing Microbiology Lab Capacity without Increasing Staff

Vore estimates automation will expand SMH’s microbiology laboratory capacity by up to 40%. “We measure that 40% in terms of the number of plates our techs can read per day with the WASPLab versus how we did it manually with our existing staff,” he explained. “We may still need to increase some staff. But even without adding staff, we thought we could move the peg further down the road in terms of throughput and improve our turnaround time too.

“We cannot make bacteria grow any faster and yet our specimen volume continues to increase,” he noted. “That makes automating microbiology the right strategy. Also, if we hadn’t automated the core lab starting in 2015, we might not have been able to handle the increased volume that we saw last year and this year’s additional surge in COVID-19 tests.”

How Lean Helped with the Implementation

Workflow in microbiology has traditionally been mostly manual. Therefore, combining Lean and automation can generate substantial benefits for a lab. “By definition, the design of the WASPLab is Lean,” Vore explained. “By that I mean the person who touches each specimen the least wins. That’s why the WASPLab is designed the way it is. Once we load a specimen in the front end, theoretically, no one needs to touch those plates until the testing is complete.”

“That’s the ideal we’re trying to reach,” he added. “At the moment, we still need to pull the plates to, as we say, ‘pick them.’ But we just introduced a way to improve that part of the process.

Adding Mass Spectrometry

“Along with the microbiology automation, we now read specimens digitally and we tell the machine to take a certain plate off so we can spot it,” Vore continued. “To speed up that process, we got some additional funding and bought a mass spec analyzer that uses MALDI-TOF to identify pathogens. Now we get the boost from the WASPLab, and we also use mass spec to cut six hours off our first read,” Vore added.

“The WASPLab and the mass spec give us higher quality incubation and better harvest of pathogens. Once we spot the plate, the mass spec can identify the pathogen in about two minutes,” he said.

“After going live with the mass spectrometry in August, we’ve made huge progress versus the normal process, where we would plate the specimen manually under a hood and then put the specimen in the incubator and pull it out to read 24 hours later,” he said.

“That whole step-by-step process to identify the pathogen could take 48 hours,” he continued. “But now we can move to a 24-hour, seven-day-a-week operation, where we can do first-in-first-out of pathogens in about 18 hours. That cuts six hours off the time to do the first plate read. Then we can spot it and get a result from the mass spec in two minutes. The impact for patient care can be tremendous.

“In a recent case, for example, we had to identify a specimen from an infant and used the mass spec to identify salmonella in two minutes,” Vore noted. “Normally that would take at least a day or more. That’s what I mean about making tremendous impact on patient care by using automation in microbiology.”

Clearly, this would be a challenging project for any medical laboratory to complete during the best of times, let alone during the early months of the COVID-19 pandemic. But through determination, the use of Lean, and a positive approach, SMH’s microbiology lab team implemented the first WASPLab in the state of Florida. And it will improve SMH’s ability to care for patients for years to come.

—Joe Burns

Related Information:

Sarasota Hospital Lab Reduces Number of Hemolyzed Specimens

Using Lean-Six Sigma to Reduce Hemolysis in the Emergency Care Center in a Collaborative Quality Improvement Project with the Hospital Laboratory

How We Reduced Hemolyzed Specimens Throughout Our Hospital and What We Do to Sustain Those Gains

Sarasota Memorial Hospital Laboratory Techs Talk Automation

Clinical Laboratory Leaders Agree: Showing Value Is More Important than Ever as Healthcare Transitions Away from Fee-for Service Reimbursement

How medical laboratories can show value through process improvement methods and analytics will be among many key topics presented at the upcoming Lab Quality Confab conference

Quality management is the clinical laboratory’s best strategy for surviving and thriving in this era of shrinking lab budgets, PAMA price cuts, and value-based payment. In fact, the actions laboratories take in the next few months will set the course for their path to clinical success and financial sustainability in 2020 and beyond.

But how do medical laboratory managers and pathologists address these challenges while demonstrating their lab’s value? One way is through process improvement methods and another is through the use of analytics.

Clinical pathologists, hospital lab leaders, and independent lab executives have told Dark Daily that the trends demanding their focus include:

  • Ensuring needed resources and appropriate tests, while the lab is scrutinized by insurance companies and internally by hospital administration;
  • PAMA’s (Protecting Access to Medicare Act of 2014) effects on reimbursement;
  • Consumers’ demand for lower cost and better access to quality healthcare;
  • Serving patients in a wider continuum of care; and
  • Collaborating instead of competing with other labs in the market.

“The laboratory and resources we are given are being scrutinized in a different way than they have been historically,” said Christopher Doern, PhD, Director of Microbiology and Associate Professor of Pathology, Virginia Commonwealth University Health System (VCU Health) Medical College of Virginia, Richmond, in an exclusive interview with Dark Daily.

“Our impact on patient care, in many cases, is very indirect. So, it is difficult to point to outcomes that occur. We know things we do matter and change patient care, but objectively showing that is a real struggle. And we are being asked to do more than we ever had before, and those are the two big things that keep me up at night these days,” he added.

This is where process improvement methods and analytics are helping clinical laboratories understand critical issues and find opportunities for positive change.

“You need to have a strategy that you can adapt to a changing landscape in healthcare. You have to use analytics to guide your progress and measure your success,” Patricia Nortmann, System Director of Laboratory Services at St. Elizabeth Healthcare, Erlanger, Ky., told Dark Daily.

Clinical Laboratories Can Collaborate Instead of Compete

Prior to a joint venture with TriHealth in Cincinnati, St. Elizabeth lab leaders used data to inform their decision-making. Over about 12 years preceding the consolidation of labs they:

  • Centralized the outreach core lab;
  • Installed front-end automation in chemistry;
  • Standardized the laboratory information system (LIS) and analyzer platforms across five affiliate hospitals; and
  • Implemented front-end automation outside the core area and in the microbiology lab.

“We are now considered a regional reference lab in the state of Kentucky for two healthcare organizations—St. Elizabeth and TriHealth,” Nortmann said. 

Thanks to these changes, the lab more than doubled its workload, growing from 2.1 million to 4.3 million outreach tests in the core laboratory, she added.

Christopher Doern, PhD (left), Director of Microbiology and Associate Professor of Pathology at Virginia Commonwealth University Health System; Patricia Nortmann (center), System Director of Laboratory Services at St. Elizabeth Healthcare; and Joseph Cugini (right), Manager Client Solutions at Health Network Laboratories, will present practical solutions and case studies in quality improvement and analytics for clinical laboratory professionals at the 13th Annual Lab Quality Confab, October 15-16, 2019, at the Hyatt Regency in Atlanta, Ga. (Photo copyright: The Dark Report.)

Using Analytics to Test the Tests

Clinical laboratories also are using analytics and information technology (IT) to improve test utilization.

At VCH Health, Doern said an analytics solution interfaces with their LIS, providing insights into test orders and informing decisions about workflow. “I use this analytics system in different ways to answer different questions, such as:

  • How are clinicians using our tests?
  • When do things come to the lab?
  • When should we be working on them? 

“This is important for microbiology, which is a very delayed discipline because of the incubation and growth required for the tests we do,” he said.

Using analytics, the lab solved an issue with Clostridium difficile (C diff) testing turnaround-time (TAT) after associating it with specimen transportation.

Inappropriate or duplicate testing also can be revealed through analytics. A physician may reconsider a test after discovering another doctor recently ordered the same test. And the technology can guide doctors in choosing tests in areas where the related diseases are obscure, such as serology.  

Avoiding Duplicate Records While Improving Payment

Another example of process improvement is Health Network Laboratories (HNL) in Allentown, Pa. A team there established an enterprise master patient index (EMPI) and implemented digital tools to find and eliminate duplicate patient information and improve lab financial indicators.

“The system uses trusted sources of data to make sure data is clean and the lab has what it needs to send out a proper bill. That is necessary on the reimbursement side—from private insurance companies especially—to prevent denials,” Joseph Cugini, HNL’s Manager Client Solutions, told Dark Daily

HNL reduced duplicate records in its database from 23% to under one percent. “When you are talking about several million records, that is quite a significant improvement,” he said.

Processes have improved not only on the billing side, but in HNL’s patient service centers as well, he added. Staff there easily find patients’ electronic test orders, and the flow of consumers through their visits is enhanced.

Learn More at Lab Quality Confab Conference

Cugini, Doern, and Nortmann will speak on these topics and more during the 13th Annual Lab Quality Confab (LQC), October 15-16, 2019, at the Hyatt Regency in Atlanta, Ga. They will offer insights, practical knowledge, and case studies involving Lean, Six Sigma, and other process improvement methods during this important 2-day conference, a Dark Daily news release notes.

Register for LQC, which is produced by Dark Daily’s sister publication The Dark Report, online at, or by calling 512-264-7103.   

—Donna Marie Pocius

Related Information:

13th Annual Lab Quality Confab October 15-16, 2019. Hyatt Regency, Atlanta, Ga.

Clinical Laboratory Innovators in Lean, Six Sigma, and Process Improvement to Gather in Atlanta October 15-16, 2019

Did The Joint Commission Omit Misdiagnosis from Its Lists of Top 10 Sentinel Events for 2018 and 2019?

Though data on delays in treatment due to misdiagnosis have been collected by TJC since 2015, misdiagnosis is not listed among the reported top 10 sentinel events

Accurate diagnosis could be the most critical aspect of all healthcare. Without accurate diagnoses, doctors may be delayed in starting treatment for their patients. In other cases, ordering inappropriate clinical laboratory tests might contribute to a misdiagnosis.

Healthcare experts know that misdiagnoses take place far too often. In fact, the Society to Improve Diagnosis in Medicine (SIDM) recently formed a coalition of more than 50 healthcare providers and patient advocacy organizations to end preventable medical diagnostic errors. (See Dark Daily, “Society to Improve Diagnosis in Medicine Forms Coalition to Address Preventable Diagnostic Errors; Proper Use of Clinical Laboratory Test Is One Goal,” September 13, 2019.)

SIDM’s analysis revealed that “one in three malpractice cases involving serious patient harm is due to misdiagnosis.” And that, “Cancer, vascular events, and infection account for three-fourths of high-harm, diagnosis-related claims.” 

Therefore, it seems odd that misdiagnosis would not be front and center on the latest list of Sentinel Events from The Joint Commission (TJC), the non-profit organization that accredits more than 21,000 healthcare organizations on behalf of the federal Centers for Medicare and Medicaid Services (CMS). Was it omitted? Perhaps not.

What Is a Sentinel Event?

The Joint Commission adopted its formal Sentinel Event Policy in 1996 as a way to help healthcare organizations improve safety and mitigate future patient risk. TJC defines a sentinel event as a “patient safety event that reaches a patient and results in any of the following:

  • “death,
  • “permanent harm,
  • “severe temporary harm, and
  • “intervention required to sustain life.” 

TJC determines healthcare events to be “sentinel” when they “signal the need for immediate investigation and response.”

Misdiagnosis leading to preventable medical errors would seem to be a sentinel event, but it is missing from TJC’s list for the past two years. It’s not, however, missing from an earlier TJC list of preventable diagnostic errors.

Delay in Treatment Due to Misdiagnosis

A 2015 TJC advisory report on safety and quality issues in healthcare, titled “Preventing Delays in Treatment,” lists misdiagnosis among several reported events that led to delays in diagnosis that then led to patient harm or death.

In that report, TJC defines “delay in diagnosis” as “a non-optimal interval of time between onset of symptoms, identification, and initiation of treatment. A delayed diagnosis occurs when the correct diagnosis is delayed due to failure in or untimely ordering of tests (e.g., [clinical laboratory] work, colonoscopies, or breast imaging studies). Whether due to delay in diagnosis, misunderstanding of the disease, misdiagnosis, or failure to treat, delay in treatment can reduce the number of treatment options a patient can pursue.”

So, misdiagnosis was, at that time, an event the TJC collected data on and included in its advisor statements. But since then, it has been omitted from the list. What changed?

Recent Sentinel Events

Turns out, nothing really. Though misdiagnosis is not listed on TJC’s lists for 2018 and 2019, it is part of a more comprehensive list published by TJC in February titled, “Most Commonly Reviewed Sentinel Event Types.” That report offers more details on the listed sentinel events, and also includes a section drawn from TJC’s 2015 report on delays in treatment, which covers results due to misdiagnosis.

In March, TJC released its top-10 list of most frequently reported sentinel events reported in 2018. They include:

  • Falls
  • Unintended retention of a foreign body
  • Wrong-site surgery
  • Unassigned
  • Unanticipated events such as asphyxiation, burns, choking, drowning or being found unresponsive
  • Suicide
  • Delay in treatment
  • Product or device event
  • Criminal event
  • Medication error

Then, in August, TJC release a new report based on the 436 reports of sentinel events TJC received in the first six months of 2019. They include:

  • Anesthesia-related events
  • Care management events
  • Criminal events
  • Environmental events
  • Product or device events
  • Protection events
  • Suicide—emergency department
  • Suicide—inpatient
  • Suicide—offsite within 72 hours (these are defined in the Sentinel Event Policy)
  • Surgical or invasive procedure events

Following the release of its March sentinel events list, TJC noted that the components were typical when compared to previous years. 

“The trend for the most frequently reported sentinel events remains generally unchanged,” stated Gerard Castro, PhD, MPH (above), Project Director, Patient Safety Initiatives at The Joint Commission, in a PSQH analysis of the Joint Commission’s 2018 list of sentinel events. “Organizations should continue their work toward minimizing risks associated with these types of events, but also strengthen systems and processes that keep patients safe, such as reporting and learning from close calls, teamwork, and improving safety culture.” (Photo copyright: The Joint Commission.)

TJC’s website notes, however, that “fewer than 2% of all sentinel events are reported to The Joint Commission. Of these, 58.4% (8,714 of 14,925 events) have been self-reported since 2005. Therefore, these data are not an epidemiologic data set, and no conclusions should be drawn about the actual relative frequency of events or trends in events over time.”

Might that be because the healthcare organizations in the US accredited by the Joint Commission are “encouraged” to report sentinel events and not “required” to do so? This also allows accredited healthcare organizations to pick and choose which events to report to TJC.

If there is one easy conclusion to draw from all the information presented above, it is that the true rate of misdiagnoses—as well as other types of sentinel events—remains unknown. But what is equally true is that, step by step, the adoption and use of electronic health systems (EHRs), along with other digital tracking modalities, will make it easier for providers and healthcare policymakers to more accurately identify and classify instances of misdiagnoses.

When that happens and better data on misdiagnoses is available, it will be possible for medical laboratory professionals to use the methods of Lean and quality management to collaborate with physicians and other providers. The first step will be to identify the sources of misdiagnoses. The second step will be to use these quality improvement techniques to support providers in ways that allow them to reduce or eliminate the causes of diagnostic errors and misdiagnoses.

—JP Schlingman

Related Information:

Sentinel Event Statistics Released for 2018

Sentinel Events (SE)

Most Commonly Reviewed Sentinel Event Types

Preventing Delays in Treatment

Sentinel Event Statistics Released for First 6 months of 2019 with New Suicide Categories

TJC Releases Compliance and Sentinel Event Stats for First Half of 2018

Lab Quality Confab and Process Improvement meeting

Innovative Clinical Laboratories of Hospitals and Health Systems Now Working to Standardize and Rationalize Lab Tests and Lab Services

It’s the next wave in the long-running trend of hospital laboratory consolidation, as the need to trim costs and support thriving medical laboratory outreach programs continues

There’s an important new development in the hospital/health system sector of the clinical laboratory industry that continues the longstanding trend of consolidating multi-site lab operations. It is to rationalize and standardize medical laboratory operations across all lab sites within the health system. Effectively, this standardization trend represents the next cycle of clinical laboratory consolidation.

One recent example of this trend can be found at Atrium Health, the hospital health network based in Charlotte, N.C. (formerly known as Carolinas HealthCare System until earlier this year). Becker’s Hospital Review states that Atrium Health is the “seventh largest nonprofit system in the country based on number of acute-care hospitals (35).”

Creating Standardized Medical Laboratory Testing Services at Multiple Sites

Over the past four years, the clinical laboratory team at Atrium Health has worked to design, build, and operate a new, state-of-the-art core laboratory. At the same time, there were sequential projects to integrate the lab testing services and operations of nine other medical lab sites within the health system to better align the test menu, lab instruments, and workflow at these sites with the activities of the core laboratory.

According to Modena Henderson, MHA, the Vice President of Laboratory Services at Atrium Health, in an interview with Dark Daily, there were multiple primary goals in this project to rationalize and standardize lab testing at all the participating lab sites. They include:

  • Standardizing lab test methodologies, reference ranges, and test menu;
  • Standardizing analyzers and test platforms across all labs;
  • Using Lean, Six Sigma, and other process improvement methods to streamline workflow and reduce test turnaround time;
  • Improve productivity of lab staff;
  • Increase quality while reducing or eliminating unproductive activities;
  • Using real-time analytics middleware to keep lab management informed on a daily basis, and,
  • Collaborating with emergency departments, wards, and outreach physicians to deliver more value with clinical lab testing services.

Using the ‘Three Ps of Project Management’ Approach in Health System Labs

The centerpiece of this program of lab rationalization and consolidation was the design and build-out for a new core clinical laboratory facility. Henderson said her team followed the principals of the “Three Ps of Project Management”—People, Process, Performance—to model the new lab facility, then guide how it was constructed and brought into daily clinical service.

“The Atrium Health laboratory regionalization project is an example of the next step that many innovative hospital laboratories are taking,” stated Robert L. Michel, Editor-in-Chief of The Dark Report. “Every lab has the same double challenge. First is financial. Hospital lab budgets are shrinking as growth in inpatient admissions slows. Outreach revenues are declining as Medicare and private payers slash lab test prices.

“Second, labs must come up with the capital needed to acquire and deploy the expensive and sophisticated new genetic and molecular tests that physicians and patients want,” he continued. “Hospital and health network labs must offer these new tests to keep their parent organizations at the cutting edge of clinical care.

Clinical Labs See Value in Standardizing Test Methodologies, Menus

“Thus, it is logical for the clinical labs of health networks to begin the process of rationalizing and standardizing their test menus, methodologies, and analyzers at every site within the system that performs medical lab testing,” emphasized Michel. “This is a development that we have watched gather momentum.”

Keynote Speaker Robert L. Michel, Editor-in-Chief of The Dark Report and Dark Daily will discuss how clinical laboratories of hospitals and health networks are rationalizing and standardizing their medical laboratory testing services to achieve the goals of managing lab costs, boosting quality, and increasing lab outreach revenue. The 12th annual Lab Quality Confab takes place on Oct. 9-10, 2018, at the Hyatt Regency Atlanta. (Photo copyright: The Dark Report.)

Michel offered two examples of sizable programs to rationalize and standardize clinical lab tests and services across a large health system. One is in Michigan, at Ascension Health. The other is in the Canadian Province of Québec. Both are large and ambitious undertakings, both in the number of lab sites involved and the large geography served by these clinical laboratories.

Consolidation Project in Québec involves 123 Clinical Lab Facilities

Québec’s provincial health system wants to consolidate 123 clinical laboratories in the province into 11 groups (clusters) of labs. Each lab group, or cluster, will have a core lab and rapid response labs. Test menus and methodologies will be standardized throughout the province. In an interview with The Dark Report, Ralph Dadoun, PhD, Project Director for Optilab Québec, plans to accomplish the consolidation without adding costs.

In Michigan, Ascension’s clinical lab leadership is working to integrate and standardize the labs that are operated by seven system organizations. This includes 14 hospitals and 18 existing laboratories located throughout the entire State of Michigan. In an interview with The Dark Report, Carlton Burgess, MSM, Vice President of Laboratory Services at Ascension Health’s St. John Providence Clinical Pathology Laboratory in Grosse Pointe Woods, Mich., stated that the goal is to have all the labs in the state work together in a seamless, integrated fashion.

Regional Lab Integration at North Carolina’s Biggest Health System

“To achieve this, the labs will be linked in four regions—a process we describe as regional integration,” explained Burgess. “Each region has a core lab and rapid response labs and each region will be responsible for building lab volume through increased outreach testing. In addition to changing how labs serve each region, our statewide standardization project has three objectives:

  • “Repatriate existing send-out lab testing back into Michigan;
  • “Establish standard test menus for each facility; and,
  • “Renew each lab’s focus on growing lab outreach business.

“Every lab administrator and pathologist working in hospital and health network laboratories should be tracking this new trend of regionalization and standardization of hospital labs,” observed Michel. “That’s because labs already moving down this path are setting new standards for the entire clinical laboratory industry. This goes beyond cost and productivity, because these labs are putting the systems in place that will allow them to deliver more value to physicians and thus be paid more for that value by private health insurers.”

Innovative Lab Leaders to Speak at Lab Quality Confab in Atlanta

Lab leaders from Ascension Health will be keynote speakers at the upcoming 12th Annual Lab Quality Confab that takes place on October 9-10, 2018, at the Hyatt Hotel in Atlanta. They will also conduct multiple learning sessions to share their successes and lessons learned in building a new core laboratory and using that as a foundation to rationalize and standardize test methods, reference ranges, menus, lab automation, and analyzers at every clinical lab facility in the Ascension Health system. Sessions by Ascension Health lab leaders include:

  • Leveraging Lean to become a Best-in-Class Lab Performer: How We Built and Automated a New Core Lab while Integrating Lab Operations and Helping Staff Embrace a New Culture; Modena Henderson, Vice President, Laboratory Services, and, Steven Harris, Assistant Vice President, Atrium Health.
  • Achieving Standardized, High-Performance Lab Testing Services at Multiple Hospitals Using Lean Methods and Effective Engagement with Lab Staff and Nurses; Gary Catarella, MBA, MT(ASCP), Assistant Vice President, Hospital Operations, Atrium Health.
  • Lessons We’ve Learned in Our Step-by-Step Journey to Transform Lab Operations and Integrate Testing across All Sites: Engaging Staff, Sustaining Change, Working with Vendors and Consultants—Interactive Roundtable Discussion; Modena Henderson, Vice President, Laboratory Services; and, Steven Harris, Assistant Vice President, Atrium Health.

Using Lean, Six, Sigma, ISO 15189 in Clinical Laboratory Operations

Lab Quality Confab this year features 60 speakers and 40 presentations from lab administrators, pathologists, and other lab managers on their successes and innovations using Lean, Six Sigma, ISO 15189, and other process management methods. You can view the full agenda here (or copy and paste this URL into your web browser:

This year’s Lab Quality Confab is on track to be the largest in its 12-year history. Limited spaces are still available. To ensure your place, register today at: (or copy and paste this URL into your web browser:

Also, you can bring your lab team and make this Lab Quality Confab a group learning opportunity. When you bring four or more from your organization, each can register for $695 for this two-day learning event. One benefit you’ll gain from bringing your team is that it will give them the knowledge, the tools, and the confidence to help your lab reduce costs without compromising quality, while supporting sustained revenue growth from your hospital lab’s successful outreach program.

—Michael McBride

Related Information:

Full Agenda and Other Details for 12th Annual Lab Quality Confab

To Register for 12th Annual Lab Quality Confab

10 Things to Know about Atrium Health, Formerly Carolinas HealthCare System

Québec’s Laboratory Consolidation Plan Aims to Save $13.5 Million: Optilab Québec to move 123 labs into 11 lab groups

Michigan’s Ascension to Standardize Labs Throughout the State: Goals Are Common Test Methods, Menus, Practices