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

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

Hosted by Robert Michel
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Direct Primary Care is Emerging as a New Healthcare Model in the US, But Are Clinical Laboratories Prepared to Bill Patients Directly?

If insurance plans are removed from the billing cycle for primary care, it’s not clear how clinical laboratories will be reimbursed for their services

Direct Primary Care (DPC) is gaining popularity in the United States. This emerging movement enables primary care providers to bill patients directly for services rendered, bypassing traditional health plans. On a large scale, employers can contract with primary care practices directly for their employees’ primary care coverage. The idea is to lower healthcare costs. But what exactly is DPC and how are clinical laboratories affected by it?

In operation, direct primary care is similar to concierge medicine, where a patient pays an annual retainer for direct access to a specific healthcare provider. DPC practices offer members unlimited, on-demand visits to primary care physicians for a flat, monthly fee.

The DPC movement has its own lobbying group—the Direct Primary Care Coalition—which supports physicians who opt to practice direct primary care. According to the group’s website, there are currently about 1,000 DPC practices in 48 states which serve over 300,000 patients. 

DPC has gained Senatorial support. In December, Senators Bill Cassidy, MD (R-LA), Doug Jones (D-AL), Jerry Moran (R-KS) and Jeanne Shaheen (D-NH) introduced legislation to “lower the cost of healthcare and expand patients’ access to their primary care providers.”

Their bill (H.R. 3708), titled the “Primary Care Enhancement Act of 2019,” would amend the Internal Revenue Code of 1986 to “allow individuals with direct primary care service arrangements to remain eligible individuals for purposes of health savings accounts, and for other purposes.”

A press release announcing the Senate version of the bill (S. 2999), described DPC as a model that “encourages patients to develop personal relationships with their primary care physician, including extending access to care beyond office visits and business hours and through telemedicine. It focuses on prevention and primary care, relying less on specialist and hospital referrals. It is a growing model used by more than 1,000 practices across 48 states and the District of Columbia.”

The press release also states, “DPC models replace copays and deductibles with flat, affordable monthly fees. Current law makes DPC incompatible with health savings accounts (HSAs) paired with high-deductible health plans (HDHPs).”

Direct Primary Care in Practice

Physicians seem to like the DPC model. It frees them, they say, from the unnecessary interference of insurance providers, the burdens of excessive paperwork, and ever-increasing administration costs, while allowing them to have a better patient-doctor relationship. 

“I know all my patients by name. I have time for them,” Matthew Abinante, DO, told The DO, a journal of the American Osteopathic Association (AOA). “I probably interact with about 20 patients a day when you factor in the electronic communication.”

Abinante is a board-certified family physician. He practices at Elevated Health, a direct primary care practice in Huntington Beach, CA. Patients pay an average of $75 per month for membership. This fee includes unlimited same day/next day appointments and the ability to talk to a doctor via telephone, e-mail, text, or video chat—24/7.

Matthew Abinante, DO, is shown above treating a patient at Elevated Health, a DPC practice in California. “Our goal is to keep you as healthy as possible, while saving you time and money. We remove the barriers of traditional insurance and provide you with a modern take on the personal, old-fashioned care missing in today’s healthcare industry,” he said. (Photo copyright: Elevated Health.)

At Elevated Health, some minor clinical laboratory tests and procedures are included in the monthly fee. They include:

Other medical laboratory testing, imaging, and medications are available to patients at contracted wholesale prices, which are quoted up front. This is consistent with the trend for price transparency in healthcare.

“What everyone really needs to know is that patients do get better care when their doctor is more satisfied with what they’re doing. And that takes time. What the [fee-for-service] system cannot provide us is time with the patient,” Tiffanny Blythe, DO, told The DO. Blythe runs Blue Lotus Family Medicine, a DPC practice in Kansas City, MO.

When Direct Primary Care Does Not Work

The DPC model has been tried before. In 2010, a DPC provider called Qliance was formed primarily on investment capital from Jeff Bezos of Amazon. The goal was to free doctors and patients from the constraints of traditional health insurance.

Qliance opened several clinics in the Seattle area and by 2014 had nearly 50,000 DPC patients—including employees of Expedia and Comcast. It also had a contract to provide primary care services with a state Medicaid insurer. Nevertheless, Qliance closed in 2017.

“We would open up a clinic and add a bunch of docs before we had enough patients to pay for it,” Nick Hanauer, a Seattle venture capitalist and investor in Qliance, told STAT.

“It’s just hard to get the customers because you had to break the paradigm that was in everyone’s heads about how healthcare had to work, and you had to disrupt the relationships people had with their insurance companies,” Hanauer explained.

“Somebody with more economic power than we had could do this—and should,” he added.

Not All Physicians Support Direct Primary Care

Since the DPC model is so new, there is little research or statistics to confirm it will have a positive effect on healthcare outcomes or lower healthcare costs. Some healthcare professionals have reservations about direct primary care. Their concerns include the potential for less oversight of practitioners and the possibility that patients will slight themselves regarding insurance coverage.

“What we don’t hear about are the people who need more than can cover and what happens to them when they fall into that gap,” Carolyn Engelhard, a health policy analyst and Assistant Professor at the University of Virginia School of Medicine. “We don’t know if they just don’t get care or then enter the traditional healthcare system and start over.”

There are also concerns that DPC plans could draw a large percentage of healthier patients, which could raise costs for those in traditional insurance plans, and that it may be more difficult for DPC patients to gain access to needed specialists and other services. 

“Healthcare is fragmented, and if we continue to have little carve-outs so some [doctors] can practice medicine the way they want, it is not helping to make the system more responsive and integrated,” Engelhard added.

Nonetheless, both Direct Primary Care and Concierge Medicine are growing in popularity in the US. And because it’s unclear how clinical laboratories would interact with or bill DPC practices, clinical laboratory leaders should keep a close eye on this trend.

As more patients opt for these models of care, healthcare organizations, pathology groups, and clinical laboratories will have to create ways to adapt. Since DPC practices are out of most networks, clinical labs may have to bill patients directly for their services. Not all clinical labs are prepared to do that, and those that are could experience a slowdown in the payment process. Labs may also have to contract with physicians to provide testing services on a pre-determined wholesale cost basis.

—JP Schlingman

Related Information:

Can Amazon Cut Insurers Out of Primary Care?

A Pioneer In ‘Flat-Fee Primary Care’ Had to Close Its Clinics. What Went Wrong?

5 Things to Know About Direct Primary Care

10 Differences Between Concierge Medicine and Direct Primary Care

Concierge Medicine Is Growing

Lessons from Qliance Closing Its Doors

New Year of 2020 Brings Issues That Fully Challenge All Clinical Laboratory and Anatomic Pathology Leaders

Changes in reimbursement models and federal compliance, as well as tougher payer audits, make it critical clinical laboratory managers are fully informed and prepared for what lies ahead in 2020

Not only does January 1st bring the new year of 2020, but it also brings tough challenges for leaders of the nation’s clinical laboratories and anatomic pathology groups. Most of these challenges are triggered by the ongoing transformation of the American healthcare system.

“Healthcare’s transformation in this country has two primary elements,” said Robert L. Michel, Editor-in-Chief of The Dark Report, sister publication of Dark Daily. “One is the integration of medical care to meet the related goals of keeping people out of hospitals—the most expensive site of care—and to proactively manage patients to keep them healthy.

“The second is reimbursement reform,” he continued. “Healthcare policymakers want to eliminate fee-for-service payments and move providers to different forms of value-based reimbursement. The federal Medicare program seems to be taking the lead over private payers as it introduces different pilot programs that reimburse physicians and hospitals through such methods as bundled payments, shared-savings arrangements, and per-member per-month (PMPM) arrangements.”

Michel predicts that both the integration of care delivery and the shift away from fee-for-service payment will become more urgent challenges for clinical laboratory managers and pathologists during 2020.

“Take the integration of care, for example. Clinical laboratories, since their inception, have been organized to serve the different provider silos,” Michel stated. “Each client—whether it was a primary care physician, a specialist doctor, a hospital, or a nursing home—could be served as a stand-alone customer. That client ordered tests and the lab performed those tests, submitted the results to that client, then billed insurance as appropriate.

“Integration of clinical care changes that laboratory service model in significant ways,” he continued. “Now, when a provider within an integrated health system orders a medical laboratory test, the lab will want those lab test results to be available, via the electronic health record (EHR) system, to other providers within that health system.

“That is one example of how integrated care requires clinical labs to realign their service model,” Michel added. “Combine that need to change with the steady transition away from fee-for-service to reimbursement based on value and you can see why all labs in the United States will be uniquely challenged, not just in 2020, but in the succeeding years.”

Robert Michel (above) is Editor-in-Chief of The Dark Report and Dark Daily and founder of The Dark Intelligence Group. He will be hosting the 25th anniversary Executive War College on Lab and Pathology Management, which takes place April 28-29, 2020, in New Orleans. (Photo copyright: The Dark Report.)

Even Minor Changes in Care Require Major Responses by Medical Laboratories

It is important for clinical laboratory managers, pathology practice administrators, and the pathologists who are the business leaders of their groups to understand the width and depth of the changes happening in healthcare and laboratory medicine in the United States today. Even little changes in how care is delivered can require a major response in how medical laboratories are organized and how they deliver lab testing services.

For example, here are distinct trends associated with how providers are responding to healthcare’s current transformation:

Meanwhile, the clinical laboratory industry is undergoing its own transformation. Three major trends illustrate how labs are responding to the new healthcare marketplace realities:

  • More use of Lean, Six Sigma, and process improvement techniques as labs strive to cut costs while protecting quality and maintaining top-flight service levels.
  • More collaboration with providers, payers, and even consumers, as innovative medical laboratory organizations move to deliver more value, consistent with the Clinical Lab 2.0 business model.
  • Acquiring more robust information technologies and analytics tools needed to leverage the lab’s clinical test data in ways to provide increased value, not just to hospitals and physicians, but to payers, patients, and a new class of care management companies that want to use big data and machine learning to help payers and providers improve patient outcomes.

All of these trends will not only be high profile during 2020, but they will be driving forces throughout the decade of the 2020s.

This is why The Dark Report’s 25th anniversary Executive War College on Lab and Pathology Management, which takes place April 28-29, 2020, in New Orleans, will feature essential sessions and expert speakers who have the answers you need to guide your lab through the challenging times yet to come.

Narrowing networks that exclude your lab from access to patients? Executive War College has health plan lab network managers to share insights with you, along with experienced lab managed care contracting executives who can challenge these payers and teach you the secrets of winning and keeping status as an in-network laboratory.

Concerned about new compliance issues—such as EKRA (Eliminating Kickback in Recovery Act of 2018) and Medicare’s recent affiliation disclosure rule for tougher government and private payer audits—that challenge your lab’s financial integrity? Executive War College is bringing together the nation’s smartest minds in compliance, billing/collections, and lab accreditation to give you first-hand updates on the must-dos and the must-avoids, so your lab is always inspection ready and compliant.

Because this is the 25th anniversary of the Executive War College, we are pulling out all the stops to put on the biggest and best conference on lab and pathology management that the nation has seen. There will be more than 125 speakers and 90 sessions, along with our always-popular two-roundtables for Lab CFOs, Academic Pathology, Lab CIOs, and Lab Quality/Compliance Managers.

Most importantly for you, this year’s Executive War College may be the most important lab management meeting you attend in 2020, because there is no other place that puts you face-to-face with experts in every aspect of clinical laboratories and anatomic pathology group management, while—at the same time—giving you unparalleled networking with the lab profession’s innovators.

This is the best investment you can make in both your professional management career and the successful operation of your laboratory.

Register today at https://dark.regfox.com/executive-war-college-2020 to reserve your seat and save $200 off regular registration rates, but act now while it’s fresh on your mind as these super-early-bird savings end January 31.

—M.A.McBride

Related Information:

25th anniversary Executive War College on Lab and Pathology Management

Post-Acute Care Cheat Sheet: Integrated Delivery Networks

Big Mergers Dominate Healthcare Headlines

Health Insurers Spending Billions to Diversify

Cigna Completes Combination with Express Scripts, Establishing a Blueprint to Transform the Health Care System

Harvard Researchers Study Whether Joint Commission Accrediting Results in Better Outcomes for Patients and Whether Accredited Hospitals Produce Better Outcomes than State-Reviewed Hospitals

In response to Harvard’s conclusions, the Joint Commission claimed the study contained “factual errors” and “multiple methodological flaws” in strong rebuttals to findings

Today’s emphasis on value-based healthcare rewards hospitals, physicians, clinical laboratories, and other healthcare service providers for improved patient outcomes. But does hospital accreditation play a role in those improved outcomes? A study published in the British Medical Journal (BMJ) suggests that hospital accreditation may not directly correlate to improved patient care and that one accrediting organization may be just as good as another.

Researchers at Harvard T.H. Chan School of Public Health (Harvard) conducted the study. They looked at healthcare outcomes from 4,400 US hospitals between 2014 and 2017, of which 3,337 were accredited (2,847 by The Joint Commission) and 1,063 received state-based reviews.

The researchers’ objective was “To determine whether patients admitted to US hospitals that are accredited have better outcomes than those admitted to hospitals reviewed through state surveys, and whether accreditation by The Joint Commission (the largest and most well-known accrediting body with an international presence) confers any additional benefits for patients compared with other independent accrediting organizations.”

In their published results, the Harvard researchers concluded:

  • “Patients treated at accredited hospitals had lower 30-day mortality rates (although not statistically significant lower rates, based on the prespecified P value threshold) than those at hospitals that were reviewed by a state survey agency … but nearly identical rates of mortality for the six surgical conditions;
  • “Readmissions for the 15 medical conditions at 30 days were significantly lower at accredited hospitals than at state survey … but did not differ for the surgical conditions;
  • No statistically significant differences were seen in 30-day mortality or readmission rates (for both the medical or surgical conditions) between hospitals accredited by The Joint Commission and those accredited by other independent organizations.”

Why is this finding important? As the largest independent accrediting organization, The Joint Commission holds enormous influence over doctors and other healthcare service providers. The Joint Commission accredits more than 21,000 US healthcare providers, as well as hospitals throughout the world. Most states require Joint Commission accreditation for hospitals to receive Medicare/Medicaid reimbursements.

However, Harvard’s study found hospitals accredited by the Joint Commission had no better patient outcomes than hospitals reviewed by state survey agencies. The conclusions published by this research team casts doubt on the perceived higher value of the Joint Commission’s accreditation over other accrediting bodies, and on the value of accreditation itself.

“There was no evidence in this study to indicate that patients choosing a hospital accredited by the Joint Commission confer any healthcare benefits over choosing a hospital accredited by another independent accrediting organization,” the researchers concluded in their paper.

Ashish Jha, MD, MPH (above) K. T. Li Professor of Global Health and Health Policy at the Harvard T. H. Chan School of Public, co-authored the Harvard study. He maintains that for accreditation to ensure hospital quality, accreditation standards must be refocused. “First, there must be a clear delineation of high-quality care (good outcomes, good experience) and that must be the guiding principle behind accreditation,” he wrote in JAMA Forum. “Hospitals should be held accountable for those outcomes. Accrediting bodies should focus on those processes and structural factors that have been convincingly shown to be associated with good outcomes.” (Photo copyright: Harvard.)

Not So Fast!

The Joint Commission is an independent, not-for-profit organization that has accredited hospitals for nearly 70 years. Approximately 81% of hospitals accredited in the US are accredited by the Joint Commission. So, of course, the Joint Commission took issue with the Harvard researchers’ findings.

In a formal statement and a response published in BMJ, the Joint Commission cited “factual errors” and “multiple methodological flaws that make the [study] results invalid.”

Nonetheless, the Joint Commission also pointed out that Joint Commission-accredited hospitals were found by the researchers to demonstrate lower mortality than state-surveyed hospitals and lower readmission rates for the medical conditions cited.

“While study authors considered the differences ‘modest,’ applying them to the more than three million patients with medical conditions addressed in this study indicates that patients treated in Joint Commission-accredited hospitals experienced 12,000 fewer deaths and 24,000 fewer readmissions,” the formal statement said. “We believe that makes a difference to patients as much as it does to us.” 

Joint Commission Partners with Leapfrog Group

Scrutiny of hospital accrediting bodies is not new. A 2002 article by The Dark Report, Dark Daily’s sister publication, reported on the Joint Commission’s decision to become a “formal partner” in the Leapfrog Group, a non-profit organization founded in 2000 that advocates for improved hospital safety and quality. (See TDR, “Provider Performance Ranking Now Hitting Healthcare System,” January 28, 2002.)

The Joint Commission announced the partnership one day before the Leapfrog Group’s release of data in the journal Quality Management in Healthcare showing “that a hospital’s accreditation status did not correlate to better quality and safety of patient care. The study specifically noted that hospitals with higher-than-average rates of deaths and complications often received favorable scores from the [Joint Commission],” TDR reported.

However, as Robert Michel, TDR’s Editor-in-Chief and Publisher, noted in the article, “The [Joint Commission’s] willingness to partner with the Leapfrog Group is a significant event. The timing of the [Joint Commission’s] announcement, one day before Leapfrog made its hospital data available to the public, demonstrates that it will become more responsive to the quality concerns of employers.

“For laboratory executives and pathologists,” Michel continued, “this is a signal event in determining how the healthcare system will evolve in the next few years. I believe it is the first of what will become a major effort to identify, measure, and report on the quality performance of all categories of healthcare providers.”

Michel made his comments in 2002. Today, hospital and individual health provider reimbursements are increasingly based on those very performance and quality-of-outcome reports.

Healthcare systems now publish data on healthcare providers so patients can make informed decisions. It is consistent with the trend to rank providers by patient outcomes and similar metrics, which TDR predicted nearly two decades ago.

Moreover, the growing availability of the outcomes data from hospitals, physicians, and other types of providers is a signal to both clinical laboratories and individual pathologists that public scorecards on the quality, outcomes, and costs of their labs or their professional pathology services are coming.

However, since major change in the healthcare system takes years to achieve, public scorecards for labs and pathologists are probably still years away as well.

—Andrea Downing Peck

Related Information:

Joint Commission Accreditation Doesn’t Lead to Better Outcomes Study Shows

Association Between Patient Outcomes and Accreditation in U.S. Hospitals: Observational Study

The Joint Commission’s Response to the October 2018 BMJ Article by Lam et. al

Rapid Response: Association between Patient Outcomes and Accreditation in U.S. Hospitals: Observational Study

JAMA Forum: Accreditation, Quality, and Making Hospital Care Better

CMS Seeks Public Comment on Accrediting Organizations and Conflicts of Interest

Structural versus Outcomes Measures in Hospitals: A Comparison of Joint Commission and Medicare Outcomes Scores in Hospitals

Provider Performance Ranking Now Hitting Healthcare System

CMS Releases Revision to State Operations Manual Special Procedures for Laboratories

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 https://www.labqualityconfab.com 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

Repeated Mistakes Led to Fatal Blood Transfusion at St. Luke’s, Report Finds

Federal Advisory Committee Seeks Public Comments on Revising CLIA Regulations, says Keynote Speaker at 13th Annual Lab Quality Confab in Atlanta

Federal Advisory Committee Seeks Public Comments on Revising CLIA Regulations, says Keynote Speaker at 13th Annual Lab Quality Confab in Atlanta

At The Dark Report’s annual Lab Quality Confab for clinical laboratory administrators, managers, and quality team members, experts outline how disruption in healthcare requires labs to improve processes and cut costs

ATLANTA, Oct. 15, 2019—Clinical laboratory professionals have a chance to advise the federal Centers for Disease Control and Prevention (CDC) on how the federal government could revise the regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). That’s according to one of the keynote speakers on Wednesday at The Dark Report’s 13th Annual Lab Quality Confab (LQC), which began here on Tuesday.

Reynolds M. Salerno, PhD, Director of the Division of Laboratory Systems (DLS) for the CDC in Atlanta, explained that the agency is collecting comments from the public and from its Clinical Laboratory Improvement Advisory Committee (CLIAC) on how to revise the CLIA regulations.

This is an opportunity for clinical laboratory directors, pathologists, and other lab professionals, to comment on the proposed revisions to CLIA before or during the upcoming CLIAC meeting on Nov. 6.

The agenda for the meeting is posted on the CDC’s website.

Public to be Heard on CLIA Regulations

“For the first time in its 26-year history, the council has called for three workgroups to address how to revise CLIA,” Salerno said. The workgroups will address these topics:

“It’s a dramatic step for the government to ask the laboratory community how to revise the CLIA regulations,” Salerno commented. Chartered in 1992, the advisory council meets twice a year, once in April and once in November.

CLIAC issued a summary report of its April 10-11 meeting. It also published an agenda for its upcoming meeting in Nov. 6.

In the coming weeks, Dark Daily will publish more information on how clinical laboratory professionals can comment on the important issue of CLIA revisions.

Digital slides from Salerno’s keynote address are posted on LQC’s presentations website.

Clinical Laboratory Testing is Increasing in Value, Keynote Speaker Says

As a service to clinical laboratories, Salerno outlined many of the services the CDC’s Division of Laboratory Systems provides for free to clinical labs, including information on such topics as:

During his remarks at the 13th Annual Lab Quality Confab in Atlanta, Salerno had good news for the clinical laboratory professionals in attendance. He said that lab testing was becoming a more valued commodity in healthcare because physicians and other providers were growing increasingly confident in lab test results. [Photo copyright: The Dark Report.]

Healthcare System Disruption Impacts Providers, Including Clinical Laboratories

Other keynote speakers addressed how disruption in the US healthcare systems affects provider organizations in significant ways. For clinical laboratories, such disruption has resulted in reduced payment and demands for quality improvement and shorter turnaround times.

For all these reasons, quality management systems may be every clinical laboratory’s best strategy to survive and thrive, the keynote speakers said.

The first keynoter was Robert L. Michel, Editor-in-Chief and Publisher of The Dark Report. Michel’s remarks focused on how price cuts from Medicare, Medicaid, private payers, and the drive for value-based payment, are requiring labs to do more with less. For this reason, quality management systems are necessary for all labs seeking to improve results, eliminate errors, and cut costs, he said.

“The people closest to the work know how to fix these problems,” he added. “That’s why labs know they must train their staff to identify problems and then report them up the chain so they can be fixed,” Michel commented. “Labs that are best at listening to their employees are getting very good at identifying problems by measuring results and monitoring and reporting on their own performance.”

Michel identified three principle factors that are disrupting healthcare:

  • The shift from reactive care in which the health system cares for sick patients to proactive care in which the health system aims to keep patients healthy and out of the hospital and other costly sites of care.
  • The transition away from fee-for-service payment that encourages providers to do more for patients, whether more care is needed or not, to value-based payment that aims to reward providers for keeping patients healthy.
  • The consolidation among hospitals, health systems, physicians, and other providers. A trend that requires clinical laboratories to find new partners and new ways to improve lab services and reduce costs.

Informatics Performance Data Help Clinical Laboratories Respond to Change

“The attributes of new and successful labs are that they will have faster workflow and shorter cycle times for clinical lab tests and anatomic pathology specimen results,” Michel explained. “That means that labs will attack non-value-added processes by implementing continuous improvement strategies [such as Lean and Six Sigma] and by the sophisticated use of informatics.”

Making use of performance data enables clinical laboratory directors to make changes in response to disruptions that affect healthcare. “If you have good informatics, then seven or eight of every 10 decisions you make will be good decisions, and with the other two and three decisions, you’ll have time to pull back and adjust,” Michel commented.

The second keynote speaker, Jeremy Schubert, MBA, MPH, Division Vice President of Abbott, reiterated what Michel said about how the health system is moving away from fee-for-service payment. Instead of focusing on caring for sick patients exclusively, he said, health insurers are paying all healthcare providers to keep patients healthy.

“Healthcare today is about the whole life course of the individual,” Schubert explained. “Patients no longer want healthcare only when they’re sick. Instead, they want to be healthy. And health creation is not just about a person’s physical health. It’s about their mental health, their emotional health, and their social wellbeing.

“In fact,” he continued, “you can learn more about a person’s health from their Zip code than from their genetic code.”

That is essentially what TriCore Reference Laboratories (TriCore) has been doing in New Mexico, Schubert added. During his presentation, Michel mentioned TriCore as being one of four clinical laboratories participating in Project Santa Fe, a non-profit organization that promotes the movement from Clinical Lab 1.0 to Clinical Lab 2.0. (See “TriCore Forges Ahead to Help Payers Manage Population Health,” The Dark Report, May 20, 2019.)

“If you want to be a quality engine in healthcare you have to be operating at Lab 2.0. Who is best qualified to interpret information? It’s the lab,” Schubert said. Then he challenged labs to begin pursuing the goal of achieving Lab 3.0, saying “Lab 3.0 is being able to interface with the patient to address each patient’s problems.”

The 13th Annual Lab Quality Confab (LQC) in Atlanta continues through the 17th with post-event workshops in Six Sigma and mastering quality management systems. In attendance are 300 clinical laboratory administrators, managers, and quality team members who are learning a complete array of professional training methods.

To register to attend, click here or enter https://www.labqualityconfab.com/register into your browser, or call 707-829-9485, or e-mail lqcreg@amcnetwork.com.

—Joseph Burns

Related Information:

Clinical Laboratory Improvement Advisory Committee Agenda for meeting Nov. 6

Clinical Laboratory Improvement Advisory Committee Summary Report

TriCore Forges Ahead to Help Payers Manage Population Health

Helping Medical Laboratories Add Value to Health Systems, Providers, and Payers by Moving from Clinical Lab 1.0 to Clinical Lab 2.0

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 https://www.labqualityconfab.com/register, 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

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