It’s the latest example of how the ongoing SARS-CoV-2 pandemic is making it possible for new competitors to enter the clinical laboratory marketplace
In response to increasing demand for COVID-19 testing, warehouse retailer Costco (NASDAQ:COST) is seizing the opportunity to sell at-home saliva self-collection test kits to its customers. It makes Costco the latest company to enter the market for SARS-CoV-2 testing and compete against clinical laboratories.
And these non-invasive tests—which are as simple as spitting saliva into a container and mailing it to a medical laboratory—may be more effective at detecting the SARS-CoV-2 coronavirus than uncomfortable nasal swabs.
Costco is selling its COVID-19 Saliva PCR Test Kit for $129.99 ($139.99 with video observation). Included in the price is a self-collection device, a biohazard bag, a sticker for personal data, and a box for shipping the saliva to a medical laboratory.
The test is actually P23 Labs’ TaqPath SARS-CoV-2 assay and will be administered by Azova, a digital health services provider. P23 says their test has a 98% sensitivity and 99% specificity, according to Business Insider.
The Costco P23 test kit above, “uses parts from Thermo Fisher Scientific and works with collection kits made by testing companies Everlywell and OraSure Technologies, according to the FDA and a P23 spokesperson,” Business Insider reported. “Samples are tested in [P23’s] lab in Little Rock, Arkansas.” (Photo copyright: Costco.)
Saliva-Collection Kits Gain Popularity and FDA Emergency Use Authorizations
P23 Labs’ assay is one of 12 COVID-19 home tests that have received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA). Three of which use saliva specimens.
The FDA’s EUA authorization summary for the P23 assay states it is “for use with saliva specimens that are self-collected at home or in a healthcare setting with or without the supervision and/or assistance of [a healthcare provider (HCP)], by individuals using the P23 At-Home COVID-19 Test Collection Kit, when determined to be appropriate by an HCP based on the results of a COVID-19 medical questionnaire. This test is also for use with nasal swab specimens that are self-collected at home or in a healthcare setting with or without the supervision and/or assistance of an HCP by individuals.”
In a news release announcing the first diagnostic test using saliva specimens, oncologist and FDA Commissioner Stephen Hahn, MD, said that “Authorizing additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19. This (saliva sample collection) provides an additional option for the easy, safe, and convenient collection of samples required for testing without traveling to a doctor’s office, hospital, or testing site.” That test was manufactured by Clinical Genomics laboratory of Rutgers New Jersey Medical School.
Below is a list from Business Insider for at-home self-collection SARS-CoV-2 coronavirus tests that have received an FDA EUA. Most can be ordered online, and prices range from $109 to $149, which may be covered by insurance depending on the health plan.
Binx Health Home Nasal Swab COVID-19 sample collection kit
Yale Study Indicates Saliva Tests Have Greater Detection Sensitivity over Swab
Should consumers choose COVID-19 saliva tests over nasal cavity swab tests? Maybe.
A study led by the Yale School of Public Health found and “conducted at Yale New Haven Hospital with 44 inpatients and 98 health care workers—found that saliva samples taken from just inside the mouth provided greater detection sensitivity and consistency throughout the course of an infection than the broadly recommended nasopharyngeal (NP) approach. The study also concluded that there was less variability in results with the self-sample collection of saliva,” states a Yale University news release.
Anne Wyllie, PhD, Associate Research Scientist at Yale School of Public Health, told Time magazine, “Saliva itself is a newer diagnostic method, and a lot of people don’t know how to work with it, are scared to work with it, or not sure how to work with it. Just because a protocol is working with swabs doesn’t mean the same protocol will work with saliva.” Nevertheless, public demand for less invasive COVID-19 testing means clinical laboratories may soon be receiving more requests for processing saliva over nasal swabs. (Photo copyright: Yale University.)
Yale received FDA EUA for SalivaDirect, a real-time quantitative polymerase chain reaction (RT-qPCR) for detection of SARS-CoV-2. However, SalivaDirect is not an “at-home” test. It requires saliva samples to be self-collected into a sterile container in the presence of a healthcare professional, and is being provided by Yale to clinical laboratories as an “open source” protocol, the FDA said in a news release.
“We are trying to work with smaller local labs that want to get up and running to support schools, community groups, universities, and colleges,” Wyllie told Time.
In “Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2,” published in the New England Journal of Medicine (NEJM), Wyllie and others suggest saliva can be just as effective in detecting the coronavirus that causes COVID-19. In their study, COVID-19 patients who were tested by healthcare workers using nasopharyngeal swabs were then asked to collect their own saliva samples.
The researchers found that “Collection of saliva samples by patients themselves negates the need for direct interaction between healthcare workers and patients. This interaction is a source of major testing bottlenecks and presents a risk of nosocomial infection. Collection of saliva samples by patients themselves also alleviates demands for supplies of swabs and personal protective equipment. Given the growing need for testing, our findings provide support for the potential of saliva specimens in the diagnosis of SARS-CoV-2 infection.”
The Yale scientists used primer sequences identified by the Centers for Disease Control and Prevention to detect the coronavirus. They found more SARS-CoV-2 RNA in saliva specimens than in the nasopharyngeal swab specimens. Also, 81% of saliva samples were positive one to five days after diagnosis, as compared to 71% of the nasopharyngeal swab specimens.
“The findings suggest saliva specimens and nasopharyngeal swab specimens have at least similar sensitivity in the detection of SARS-CoV-2 during the course of hospitalization,” the researchers wrote in their NEJM paper.
The increasing popularity of at-home COVID-19 testing—along with studies showing that results improve when specimens are self-collected—suggest that medical laboratory managers should closely monitor the rise of COVID-19 home tests, as well as progress being made in saliva for diagnosing the SARS-CoV-2 coronavirus.
Further, it might be a smart strategy for clinical laboratories with the capability to perform this testing to approach retailers in their region and establish relationships where retailers sell the collection kits, and the lab performs the test and reports the results.
Since patients pay cash for the SARS-CoV-2 tests at the time they purchase the kits, clinical labs are guaranteed payment for the tests without the need to submit claims to consumers’ insurance companies. That’s another benefit to these types of arrangements.
United Airlines creates pilot program for on-site rapid PCR tests, as other airlines facilitate at-home specimen collection for rapid coronavirus testing
Four US airlines attempting to recover lost business due to the COVID-19 pandemic are partnering with developers of rapid RT-PCR (reverse transcription polymerase chain reaction) tests to facilitate testing of passengers either at airports before they board their flights, at drive-through testing sites, or at-home in advance of scheduled travel.
This would be a great opportunity for clinical laboratories to gain business, but few details are known about how these airlines are selecting providers for the COVID-19 tests that will be part of their programs.
The deals come amid calls from the International Air Transport Association (IATA) “for the development and deployment of rapid, accurate, affordable, easy-to-operate, scalable and systematic COVID-19 testing for all passengers before departure as an alternative to quarantine measures” in many countries, states an IATA press release.
“The key to restoring the freedom of mobility across borders is systematic COVID-19 testing of all travelers before departure,” said Alexandre de Juniac, IATA Director General and CEO, in the IATA press release. “This will give governments the confidence to open their borders without complicated risk models that see constant changes in the rules imposed on travel.”
From a clinical laboratory testing perspective, the requirement for passengers to be tested prior to travel may contribute to two changes in the lab testing marketplace:
Consumers may become accustomed to buying home collection kits for COVID-19 and sending specimens to clinical laboratories. This could have the added benefit of helping consumers become comfortable doing this for other diagnostic tests as well.
Pursuit of profit from manufacturing COVID-19 tests that utilize consumer-collected specimens may increase competition in this market and would likely increase the number of at-home specimen collection products that are easier and more convenient to use.
US carriers offering the COVID-19 tests include United Airlines, American Airlines, Hawaiian Airlines, and JetBlue.
United Airlines
United is providing on-site testing through pilot programs at San Francisco International Airport (SFO) and Newark Liberty International Airport (EWR). At SFO, passengers are tested before taking flights to Hawaii. At EWR, they are tested prior to boarding a thrice-weekly flight to London Heathrow.
“We believe the ability to provide fast, same-day COVID-19 testing will play a vital role in safely reopening travel around the world and navigating quarantines and travel restrictions, particularly to key international destinations like London,” said Toby Enqvist, United’s Chief Customer Officer, in a press release.
United began offering testing at SFO on Oct. 15. According to “COVID-19 Testing for United Travelers,” the San Francisco to Hawaii passengers have two options:
A $105 drive-through test administered two or three days prior to flights by Color, a San Francisco Bay area health technology company.
The airline says a negative test ensures that travelers can bypass Hawaii’s mandatory quarantine requirements in Lihue, Maui, and Honolulu. For the Newark-to-London flights, United plans to run a pilot rapid testing program from Nov. 16 to Dec. 11. for passengers boarding Flight 14, departing at 7:15 p.m. Mondays, Wednesdays, and Fridays. Premise Health will administer the testing, which will be free to passengers. Those who choose not to be tested will be placed on other flights.
A United Airlines flight attendant (above) receives an RT-PCR test for COVID-19 prior to boarding. If the flying public embraces preflight coronavirus testing, including at-home specimen collection kits, clinical laboratories may see a spike in requests for test processing. (Photo copyright: The Washington Post.)
American Airlines
American is offering COVID-19 testing for passengers scheduled on flights to Hawaii, Latin America, and the Caribbean, according to a press release. For the most part, these are at-home specimen collection RT-PCR tests provided by healthcare testing services company PrivaPath Diagnostics, Inc. (d.b.a., LetsGetChecked). Customers receive their results within 24 to 72 hours after the lab receives the samples.
As with the United flights to Hawaii, the testing program allows passengers to bypass quarantine requirements at their destinations. Customers pay $119 for the LetsGetChecked at-home specimen-collection kit and subsequent RT-PCR testing.
“Our initial preflight testing has performed remarkably well, including terrific customer feedback about the ease and availability of testing options,” American Airlines President Robert Isom said in the press release.
Hawaiian Airlines and JetBlue
In separate press releases, Hawaiian Airlines and JetBlue announced partnerships with Vault Health to offer at-home saliva tests to passengers. After receiving the at-home specimen collection kit, customers can connect through Zoom video conferencing with a Vault Health supervisor who ensures the sample is collected properly.
Hawaiian Airlines also offers drive-through testing at SFO and Los Angeles International Airport through a partnership with Worksite Labs. Passengers pay $90 to receive test results within 36 hours or $150 for express service on the day of travel. Worksite uses a Droplet Digital PCR shallow nasal swab test. The airline says it plans to expand this to other airports.
The Vault Health and Worksite Labs tests meet the state’s guidelines for exemption from the 14-day quarantine requirement, the airlines say.
Impact on Medical Laboratories
Airlines offering COVID-19 testing to their passengers may trigger both an opportunity and a change in the clinical laboratory testing marketplace. First, there is a business opportunity for labs to provide rapid molecular SARS-COV-2 tests to airlines.
Second, if consumers begin using at-home specimen collection kits in greater numbers as part of their air travel requirements, might this make them more comfortable doing self-collection for other types of clinical laboratory tests? A shift in consumer willingness to collect their own medical laboratory specimens—accompanied by ongoing innovations in diagnostic technologies, may eventually reduce the need for medical labs to operate extensive networks of patient service centers.
Of course, such a scenario is years away. But airline COVID-19 testing programs are just one of the progressive steps that can help make that possibility into a reality.
Clinical laboratory managers and pathology practice administrators should consider how these trends may affect their business and patients when planning for the future.
The McKinsey graphic above illustrates the “six trends that are likely to shape post-COVID-19 healthcare.” Clinical laboratories that support health networks struggling with any of these challenges should take steps to prepare for anticipated changes to healthcare delivery. (Graphic copyright: McKinsey and Company.)
1: Healthcare Reform
McKinsey identified three areas where the coronavirus pandemic may impact healthcare reform:
“COVID-19-era waivers that could become permanent.
“Actions that may be taken to strengthen the healthcare system to deal with pandemics.
“Reforms to address the COVID-19-induced crisis.”
McKinsey reports that “the Centers for Medicare and Medicaid Services has introduced more than 190 waivers since the beginning of March 2020.” These waivers can affect all aspects of healthcare, from clinical practice to reimbursement. Some of them, according to McKinsey, are “only relevant during the crisis (for example, the waiver of intensive care unit death reporting). A retrospective assessment of others (for example, expansion of telehealth access) could reveal beneficial innovation worth preserving.”
Several areas that McKinsey says are clearly ripe for reform include improving the resiliency of the healthcare system and the way the system is funded.
Public sector budgets are generally kept strictly separate, each with its own rules and policies that dictate operations. But in his article, “After COVID-19—Thinking Differently About Running the Health Care System,” published in JAMA Health Network, Stuart M. Butler, PhD, Senior Fellow in Economic Studies at the Brookings Institution, wrote, “The intensity of the COVID-19 pandemic … is forcing jurisdictions all across the country to find ways to be nimble so that multiple agencies can work together.”
Thus, McKinsey recommends, “Given the substantial shifts in relative market positioning among industry players that prior reforms have created, leaders would do well to plan ahead now.”
2: Better Access to Healthcare Services
Some people who develop COVID-19 are at far greater risk of hospitalization and death than others, including those who have:
Chronic health conditions, including obesity.
Mental and behavioral health challenges, such as substance abuse.
Unmet social needs, such as food or housing insecurity.
Poor access to healthcare.
McKinsey wrote that these “intersecting health and social conditions,” combined with certain races that have higher risk for severe complications, including Black, Indian, and Hispanic/Latino Americans, “correlated with poorer health outcomes.”
Value-based healthcare, telehealth, and greater attention to the social determinants of health may help address some of these issues, McKinsey notes, but the pandemic has shined a spotlight on how lack of care increases risk for certain populations during a public health crisis.
3: Era of Exponential Improvement Unleashed
Some of the trends that appear to be accelerating as a result of the pandemic are good news. McKinsey cites several benefits, including:
Improved understanding of patients.
Delivery of more convenient and individualized care.
$350-$410 billion in annual revenue by 2025.
Through telehealth and other types of virtual care enabled by digital technology, “intuitive healthcare ecosystems” may arise and offer a more integrated experience for patients and their caregivers, McKinsey notes.
“While the pace of change in healthcare has lagged other industries in the past, potential for rapid improvement may accelerate due to COVID-19. An example is the exponential uptake of digitally enabled, virtual care,” McKinsey wrote. “Our analysis … showed that health systems, primary care, and behavioral health practices are reporting increases of more than 50–175 times in telehealth visits, and the potential market size for virtual care could reach around $250 billion.”
The graphic above is taken from the McKinsey and Co. report, which noted, “Proliferation of digitally enabled, virtual care could further contribute to the rise of personalized and intuitive healthcare ecosystems [that] have the potential to deliver an integrated experience to consumers, enhance productivity of providers, engage both formal and informal caregivers, and improve outcomes while lowering cost.” (Graphic copyright: McKinsey and Company.)
4: The Big Squeeze
The pandemic has caused an enormous outflow of cash from the healthcare system, and some experts don’t expect an injection of funding until 2022. “This outflow is expected to be primarily driven by coverage shifts out of employer-sponsored insurance and possible coverage reductions by employers as well as Medicaid rate pressures from states,” McKinsey states.
“We estimate that COVID-19 could depress healthcare industry earnings by between $35 billion and $75 billion compared with baseline expectations,” McKinsey predicted, adding, “Select high-growth segments will remain attractive (for example, virtual care, home health, software and platforms, specialty pharmacy) and will disproportionally drive growth. These high-growth areas are expected to increase more than 10% over the next five years, while other segments may stagnate or decline altogether.”
5: Fragmented, Integrated, Consolidated Care Delivery
McKinsey says, “The shift of care out of hospitals is not new but has been accelerated by COVID-19.” Rather than the hospital being the center of care delivery, patients are increasingly choosing to receive care at a range of sites across many healthcare ecosystems that are connected digitally and through analytics.
Early in the course of the pandemic, visits to ambulatory care facilities dropped nearly 60% by early April. But by mid-May, those visits were beginning to rebound.
In, “The Impact of the COVID-19 Pandemic on Outpatient Visits: A Rebound Emerges,” the Commonwealth Fund reported that “the relative decline in visits remains largest among surgical and procedural specialties and pediatrics” but is “smaller in other specialties, such as adult primary care and behavioral health.”
The McKinsey graphic above shows how “virtual care and outpatient options show more potential revenue growth through 2022.” Clinical laboratories that support those healthcare settings, especially ambulatory surgery, behavioral health, and retail clinics, should experience similar growth. (Graphic copyright: McKinsey and Company.)
6: Adoption of Next-Generation Managed Care Is Accelerating
How will COVID-19 affect the managed care industry? McKinsey says the “next generation” of managed care might use Medicare Advantage as a model.
“Payers pursuing the next generation of managed care model (through deep integration with care delivery) demonstrate better financial performance, capturing an additional 50 basis points of earnings before interest, taxes, depreciation, and amortization above expectation,” McKinsey noted, adding, “Employers and payers could consider fundamentally rethinking how employer-sponsored health coverage is structured. Learning from Medicare Advantage could provide inspiration for such a reimagination.”
What Should Clinical Laboratory Managers Do?
The McKinsey article concludes by stating, “While the challenges are numerous, leaders who seize the mindset that “disruptive change provides an opportunity to separate yourself from the pack” will build organizations meaningfully stronger than the ones they ran going into the crisis.”
The McKinsey article authors recommend that healthcare organizations take several proactive steps, including:
Launch a plan-ahead team.
Question your role and your future business model.
Prepare to transform your business.
Reimagine your organization to make faster decisions.
Take action to drive health equity.
Though the McKinsey and Company article covered healthcare in general, many of the authors’ observations and recommendations can apply to clinical laboratories and pathology groups as well and may be valuable in future planning.
Non-hospital-owned ambulatory care providers continue to take revenue from hospitals, as more patients choose urgent care centers and other options over emergency rooms
Thanks to the popularity of urgent care clinics and other non-hospital-based ambulatory care providers, the year-over-year growth in the number of hospital outpatient visits has been on the decline for decades. Dark Daily has covered this trend in many e-briefings over the years. But now, for the first time since 1983, outpatient visits fell below the previous year among more than 6,000 hospitals surveyed by the American Hospital Association (AHA).
This is an important event, because anything that affects a hospital’s
revenue also affects that hospital’s medical laboratories and everyone
connected to it. The decline, according to the AHA, is primarily due to decreasing
visits to hospital emergency rooms. ERs provide significant revenue for
hospitals. Fewer ER visits means less clinical laboratory test ordering, fewer
image study requests, and may mean lower financial revenues overall.
The AHA released the findings in its “2020 Hospital Statistics Report.” The data show that outpatient visits to hospitals have decreased one year to the next for the first time in 35 years.
The AHA surveyed 6,146 hospitals located throughout the
nation. In 2017, those hospitals recorded a total of 880.5 million outpatient
visits. In 2018, those same hospitals delivered 879.6 million outpatient visits,
a reduction of 0.09% over the previous year.
That survey result marked the first time since 1983 that there was a decrease in outpatient visits from one year to the next, Modern Healthcare reported. The article goes on to state that the AHA’s report, “highlights the fact that patients are increasingly gravitating toward the countless disruptors that tout more convenient, cheaper options for primary care, urgent care, and even emergency care.”
The graphic above, taken from the American Hospital Association’s “2020 Hospital Statistics Report,” illustrates the decline in hospital outpatient visits since 1983. Besides studying ER visits, the AHA also surveyed hospital-owned ambulatory surgery centers, outpatient clinics, and walk-in clinics. Visits to those outpatient facilities remained stable, according to the AHA, or rose slightly from the previous year. Nevertheless, a decrease in visits to ERs means fewer clinical laboratory test and image study requests. (Graphic copyright: American Hospital Association.)
More Options for Receiving Healthcare Services
One of the main reasons for the decrease in hospital
outpatient visits is that patients have more options when seeking care. The
rise in the number of urgent care and walk-in clinics has provided healthcare
consumers with more convenient, less expensive options than traditional
hospital settings.
“We’re pivoting to a new business model in healthcare, with a much more pluralistic delivery system with many, many more consumer options,” Ken Kaufman, Chairman of management consulting firm Kaufman Hall, told Modern Healthcare. “Which, of course, is exactly the same thing that’s happening in other parts of the economy. I think it’s very important that especially the major health systems recognize this and realize they have to compete against it.”
Gap Between Inpatient and Outpatient Revenue Narrows
The AHA’s survey also found that, though there were fewer
outpatient visits to emergency rooms, the surveyed hospitals’ net outpatient
revenue actually increased by 4.5% from 2017 to 2018, and that the gap between
outpatient and inpatient revenue for hospitals continues to narrow.
In 2017, outpatient revenue for the hospitals was $494
billion, while inpatient revenue was $508 billion. That meant that total
outpatient revenue was 97% of the new inpatient revenue for 2017. In 2018, that
percentage was 95%; however, in 2016, it was 92%.
“I don’t know that I can speculate as to when they will converge, but the trend lines seem to be getting closer,” Aaron Wesolowski, Vice President, Policy Research, Analytics, and Strategy at AHA, told Modern Healthcare.
Though Outpatient Revenues Increased, Hospital Profits
Decreased
The AHA survey found that, overall, hospital profits
decreased by 5.2% when comparing 2017 to 2018. In 2017, the hospitals reported
a combined profit of $88 billion, but only a profit of $83.5 billion for
2018.
Wesolowski noted that the most likely reasons for the decrease
in profits were due to:
Continued lower reimbursements from public
payers;
The shift from inpatient to outpatient care;
Increasing labor costs; and
Increasing costs for drugs and supplies.
AHA annual hospital surveys also collected aggregate data
regarding payments and costs associated with hospital care to beneficiaries of
Medicare and Medicaid services. Those
surveys found that:
Combined underpayments to hospitals totaled
$76.6 billion in 2018, which included a shortfall of $56.9 billion for Medicare
and $19.7 billion for Medicaid.
In 2018, 66% of surveyed hospitals received
Medicare payments less than cost and 61% received Medicaid payments less than
cost.
Hospitals received payment of only 87 cents for
every dollar spent caring for Medicare patients in 2018.
Hospitals received payment of 89 cents for every
dollar spent caring for Medicaid patients in 2018.
Additionally, according the “AHA Hospital Statistics 2020 Edition,” the total number of admissions for all US hospitals in 2018 was 36,353,946, while total expenses for all US hospitals in the same year totaled an astronomical $1,112,207,387,000.
With more convenient and less expensive options for medical
care are becoming increasingly available to consumers, competition for
outpatients will continue to increase. In the interest of producing new revenue
sources—or just maintaining existing revenues—it would be prudent for clinical
laboratory leaders to develop strategies for providing lab testing services to
the growing number of outpatient ambulatory healthcare providers that compete
with hospital ERs.
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
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.
