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.
This rural health system has nearly a decade of experience offering cash-only package pricing for medical services including, most recently, inpatient stays
While healthcare networks and hospital organizations nationwide argued over pricing transparency, Pomerene Hospital in Millersburg, Ohio, embraced the concept. The not-for-profit hospital developed packages of care that include “one all-inclusive price for tests, procedures, and episodes of care, rather than a lengthy list of itemized charges that didn’t even include professional fees” for its self-paying customers, Modern Healthcare reported.
A companion proposed rule (CMS‑9915‑P) will, if passed, require health plans and healthcare insurers to disclose covered healthcare costs to customers upon request, including “an estimate of such individual’s cost-sharing liability for covered items or services furnished by a particular provider.”
These rules have created a fire storm of controversy. Hospital systems and healthcare organizations like the American Hospital Association (AHA) argue that revealing payer-negotiated rates will undermine health networks’ negotiating power with insurers and increases hospital prices.
They may be right. But that hasn’t stopped one health
network in rural Ohio from providing a blueprint on price transparency that
could be a model for the rest of the nation—at least for one segment of its
customer base.
Bundled Care Packages Increase Revenues at Pomerene
Pomerene is a not-for-profit healthcare provider established
in 1919. Originally, the tiny hospital had “a six bed women’s ward, a three bed
men’s ward, six private rooms, a three bed OB ward, and a nursery with five
cribs. There were ten physicians on staff,” notes the hospital’s website.
Today, Pomerene has more than 325 employees, 80 physicians, and 55 licensed beds. The hospital has 30 departments on three floors and is one of the largest employers in Holmes County.
Pomerene has developed bundled care packages for more than 300 services—including inpatient care—for Amish and Anabaptist patients, as well as any other self-pay patients who pay their bills in full at the time of service, Modern Healthcare reported.
The initiative came in response to concerns raised by the
area’s Amish and Anabaptist communities, which make up roughly 40% of the
county’s population. They do not use commercial health insurance. Instead, they
pay their medical bills out of pocket, and when they are unable to pay for
medical services, benefit actions and church support fill the financial gaps.
Church members asked Pomerene for guaranteed bundled pricing.
They did not want the uncertainty of hospital bills that might include lists of
itemized charges, but not professional fees and other potential costs.
“We have our own healthcare,” a retired Amish carpenter (who asked that his name not be used) told Reuters. “They (hospitals) give you a bill. If you can’t pay it, your church will.”
Both religious groups also value thriftiness and are known
to be fierce negotiators. In recent years, they lobbied Pomerene Hospital to
include inpatient care in its all-inclusive pricing structure.
“We assume a certain level of risk with this financial arrangement,” Pomerene Hospital CEO Jason Justus, who at the time was Pomerene’s Chief Financial Officer, told Modern Healthcare. “But it’s about saying what we’ll do and doing what we say. That builds a great deal of trust in the community.” Justus took over as CEO in July, 2019, reported The Daily Record.
Jason Justus, CEO, is shown above to the right of Tony Snyder, former CEO of Pomerene Hospital until July of 2019. Initially, Snyder was concerned that posting the hospital’s prices would discourage the Amish from seeking care at his hospital. “They are shrewd business folks, they are price sensitive, and they will shop,” he told Modern Healthcare. “They don’t expect you to lose money, but they don’t want to be paying exorbitant margins.” Fortunately, price transparency had the opposite effect. “We were holding our breath,” Justus said. “We were optimistic it would work, and we were pleasantly surprised when it did.” (Photo copyright: The Daily Record.)
In total, nearly one-quarter of the hospital’s patient revenue comes from bundled-service packages, with 3,387 packages provided last year, Modern Healthcare reported. In 2018, Pomerene brought in $36,971,931 in operating revenue, according to Modern Healthcare Metrics.
Bundled Payments Drive Innovation
Bundled payments also have forced hospital administrators and staff at Pomerene to find innovative ways to cut costs by shortening patient stays. For example, Modern Healthcare reported that the length of hospital stay for childbirth, which at the time averaged two-to-four days, dropped to 24 hours after the hospital created a 24-hour package for obstetrical deliveries. Within 18 months, 80% of childbirth cases fit the 24-hour model.
“Here is free market economics at work,” said Robert Michel,
Dark Daily’s Editor-in-Chief. “This hospital understands that it must
meet the needs of this unique group of patients with good service and quality
at a fair price. That understanding comes with an incentive for the hospital’s
staff to identify and implement innovations to cut costs while improving
quality.”
However, Pomerene Hospital’s policy of disclosing prices to patients in advance of services remains uncommon in the healthcare industry. “Outside of Medicare, bundled pricing is rare-to-nonexistent among full-service US hospitals, most of which say they don’t know their actual costs for providing care and, therefore, can’t offer such prices,” Modern Healthcare stated.
For competitive reasons, Pomerene does not publicly post its
package prices and only prospective cash-paying patients are provided the cost
breakdowns. That will most likely change following enactment of the CMS final
rule.
Other Health Systems That Bundled Prices
Though Pomerene does not shares its price-packaging methods
with other hospitals, its track record for attracting cash-paying patients made
it an example to other hospitals serving similar religious communities.
The Medical Center at Scottsville in Kentucky followed Pomerene’s lead and discounted cash prices—paid upfront or before discharge—by 25% for 300 medical services, including childbirth and common surgical procedures. This was to attract the area’s Mennonite population, noted Quartz magazine.
“I will tell you they are very conscientious about cost.
They are very business-savvy and will shop around,” Eric Hagan, Regional
Vice President of Operations at Med
Center Health and Administrator of the Medical Center at Scottsville, told Quartz.
Will Americans as a whole be just as eager to shop for
medical services? The answer to that question may determine whether increased
price transparency throughout healthcare, including clinical laboratory testing
and anatomic pathology services, results in lowering their healthcare costs.
Experts say Amazon could be planning a roll-out of healthcare services to its Prime members and others
Clinical laboratory leaders will want to note that the Telehealth and home healthcare industries have expanded with the launch of Amazon Care, a virtual medical clinic and home care services program from global retailer Amazon.com, Inc. (NASDAQ:AMZN).
Amazon is piloting Amazon Care as a benefit for its 53,000
Seattle-area employees and their families, according to published reports. Could
this indicate the world’s largest online retailer is moving into the primary
care space? If so, clinical laboratory leaders will want to follow this
development closely, because the program will need clinical laboratory support.
Amazon has successfully disrupted multiple industries in its
corporate life and some experts speculate Amazon may be using its own employees
to design a new medical delivery model for national roll-out.
The S&P report goes on to state, “In as little as five years, the Seattle-based e-commerce company could interlink its system of capabilities and assets to launch various healthcare products, insurance plans, virtual care services, and digital health monitoring to a broader population. The rollout would be part of a larger plan by Amazon to deliver convenient, cost-effective access to care and medications across the U.S., likely tied to Amazon’s Prime membership program, according to experts.”
Modern Healthcare reported that Amazon Care services include telemedicine and home visits to employees enrolled in an Amazon health insurance plan.
Experts contacted by S&P Global Market Intelligence
suggest Amazon:
Plans a “suite of customized health plans and
services for businesses and consumers;”
May offer health services to its five million
seller business and more than 100 million Amazon Prime members; and
Sees healthcare as a growing market and wants
greater involvement in it.
How Amazon Care Works
Amazon Care offers online, virtual care through a
downloadable mobile device application (app) as well as in-person home care for
certain medical needs, such as:
Colds, allergies, infections, and minor injury;
Preventative consults, vaccines, and lab tests;
Sexual health services; and
General health inquiries.
Becker’s Hospital Review reported that once a participant downloads the Amazon Care app to a smartphone or tablet and signs up for the program, he or she can:
Communicate with healthcare providers via text
or video;
Plan personal visits if needed;
Set payment methods in their user profile; and
Receive a “potential diagnosis” and treatment
plan.
The graphic above is taken from the S&P Global Market Intelligence report, which states, “Amazon is one of several tech firms vying for a share of the healthcare market where national spending is expected to reach $6.0 trillion by 2027, up from $3.6 trillion in 2018, according to the Centers for Medicare and Medicaid Services.” (Graphic copyright: S&P Global Market Intelligence.)
“The service eliminates travel and wait time, connecting employees and their family members to a physician or nurse practitioner through live chat or voice,” an Amazon spokesperson told CNBC, “with the option for in-person follow-up services from a registered nurse ranging from immunizations to instant strep throat detection.”
The “mobile health nurse” may also collect clinical laboratory
specimens, the Verge
reported.
Amazon has partnered with Oasis Medical Group, a family primary care practice in Seattle, to provide healthcare services for Amazon Care patients.
Paving the Way to Amazon Care
The Healthcare Financial Management Association (HFMA) compares Amazon’s piloting of Amazon Care to similar healthcare projects that studied population health by first involving employee health plans.
HFMA’s analysis noted that Amazon Care is similar to Haven, a patient advocate organization based in Boston and New York that was created in 2018 by Amazon, JPMorgan Chase, and Berkshire Hathaway to lower healthcare costs and improve outcomes for participating companies.
Tech Crunch reported that in 2018 Amazon also purchased PillPack for nearly $1 billion and integrated its prescription delivery services into Amazon Care.
More recently, Amazon acquired Health Navigator and plans to bring those offerings to Amazon Care as well, CNBC reported. Founded in 2014, Health Navigator provides caregivers with symptom-checking tools that enable remote diagnoses.
Should Telemedicine Firms Be Nervous?
Dark Daily recently reported on Doctor on Demand’s launch of its own virtual healthcare telehealth platform called Synapse. The e-briefing also covered Doctor on Demand’s partnership with Humana (NYSE:HUM) to provide virtual primary care services to the insurer’s health plan members, including online doctor visits at no charge and standard medical laboratory tests for a $5 copayment.
So, should telemedicine firms be concerned about Amazon competing in their marketplace? Business Insider predicts Amazon will need time to beef up its medical resources to serve people online and in-person through Amazon Care.
But that’s the point of Amazon’s pilot, isn’t it? What comes
from it will be interesting to watch.
“Meanwhile, telemedicine firms can ink strategic
partnerships and strengthen their existing payer relationships to safeguard
against Amazon’s surge into the space,” Business Insider advised.
It remains to be seen how medical laboratory testing and reports
would fit into an expanded Amazon Care health network. Or, how clinical laboratories
will get “in-network” with Amazon Care, as it grows to serve customers beyond
Amazon’s employees.
As Dark Daily recently advised, medical laboratory leaders will want to ensure their lab’s inclusion in virtual care networks, which someday may include Amazon Care.
In a federal lawsuit, seven healthcare organizations and hospitals systems allege HHS exceeded its statutory authority and clinical laboratories will want to watch how this court case unfolds
There is quite a brouhaha over the final new federal rule requiring hospitals to allow patients and the public to see the prices they charge for services—including clinical laboratory and anatomic pathology prices. Some very influential hospital associations and healthcare systems are opposing implementation of this rule.
For more than a decade, Dark Daily has
reported on the federal government’s efforts to enact pricing transparency in
healthcare. In many e-briefings, we advised pathologists
and medical
laboratory leaders that the outcome of those efforts will likely affect
clinical laboratory workflows and bottom lines, and that many clinical laboratories
are not prepared to negotiate directly with customers over the price of their
services.
Now, the federal Centers for Medicare and Medicaid Services
(CMS) has passed a final
rule (CMS-1717-F2) that expands on an earlier rule mandating pricing
transparency for hospital procedures—including medical
laboratory and anatomic
pathology services. This new rule requires hospitals to disclose not only
their chargemaster
prices, but also prices negotiated with payers.
Hospital leaders are not pleased by this, and though the
final rule does not go into effect until January 1, 2021, they are already
pushing back through representative organizations such as the American Hospital Association (AHA), which has
brought a lawsuit to federal court that seeks to overturn the new rule.
New Transparency Rules Include Rates Negotiated with Health
Insurers
Beginning Jan. 1, 2019, CMS required hospitals to disclose chargemaster prices to customers. These are essentially the “list prices” for hospital procedures. However, as Dark Daily reported in “California Healthline Report Finds Hospital Chargemaster Prices Fluctuate Dramatically Even Among Hospitals Located Near Each Other,” June 12, 2019, there were problems. Chargemaster prices typically do not reflect the actual fees charged to patients or payers. Thus, consumers still found it problematic to price shop before committing to healthcare.
In an effort to remedy this, the
new 2020 final rule expands the pricing information hospitals are required to
provide and includes several categories of prices negotiated with health insurers.
Simultaneous to this final rule, CMS also announced a
proposed rule (CMS-9915-P) titled, “Transparency
in Coverage,” that if passed, will require health insurers to disclose
pricing for healthcare services as well.
In a federal Department of Health and Human Services (HHS) press
release, the Trump Administration stated that both rules will “increase
price transparency to empower patients and increase competition among all
hospitals, group health plans, and health insurance issuers in the individual
and group markets.”
“Under the status quo, healthcare prices are about as clear
as mud to patients,” said CMS Administrator Seema Verma in the HHS press
release. “This final rule and the proposed rule will bring forward the
transparency we need to finally begin reducing the overall healthcare costs.”
AHA Sues HHS in Federal Court
In response, four hospital organizations and three health
systems filed a
lawsuit in federal court against the HHS. The suit alleges the final rule
“exceeds the agency’s statutory authority,” and violates the First Amendment by
requiring public disclosure of prices negotiated with payers. This information,
they say, is “highly confidential and commercially sensitive.”
In court
documents, the plaintiffs argue that “the Final Rule is arbitrary and
capricious and lacks any rational basis. The agency’s explanation for the Final
Rule runs counter to both logic and evidence. In fact, it is belied by the
agency’s own research regarding what patients care about most when selecting a
hospital: their own out-of-pocket costs. The agency’s justification for the
Final Rule therefore does not stand up to even the barest of scrutiny. That is
the epitome of arbitrary and capricious agency action.”
A brief
filed by the plaintiffs contends that patients’ actual out-of-pocket costs
are determined by a complex set of factors and aren’t reflected in negotiated
rates. In addition, the brief states, “the sheer burden of compliance with the
rule is staggering, and way out of line with any projected benefits associated
with the rule.”
Charles N. Kahn III (above), President and CEO, Federation of American Hospitals (FAH), said in an AHA press release that, “CMS’ final rule fails to offer patients easy-to-understand information regarding their out-of-pocket obligations for care, so we feel obligated to contest the regulation. We contend the agency exceeded its authority and should go back to the drawing board.” (Photo copyright: FAH.)
Details of the Final Rule on Hospital Price Transparency
If it goes forward, starting Jan. 1, 2021, the final rule
requires hospitals to disclose five types of standard charges, according to the
HHS and AHA press releases:
The chargemaster rate, also known as the gross
charge;
The discounted cash price, which CMS defines as
the amount the hospital will accept from self-paying patients;
The payer-specific negotiated charge, defined as
“the charge that the hospital has negotiated with a third-party payer for an
item or service.” This would be the charge that applies if a patient uses an
in-network provider;
The maximum charge negotiated with payers; and
The minimum charge negotiated with payers.
Hospitals must list these charges for all billable “items
and services,” including medical laboratory and pathology services, in a
machine-readable format, such as a CSV file that
can be opened in a spreadsheet program.
In addition, they must provide a “consumer-friendly” list of charges for at least 300 “shoppable services,” defined as services that consumers can schedule in advance. Each list would include 70 services specified by CMS and an additional 230 services selected by the hospital.
The CMS-specified shoppable services include 14 laboratory
and pathology tests. They include:
Basic metabolic panel
Blood test, comprehensive group of blood
chemicals
Obstetric blood test panel
Blood test, lipids (cholesterol and triglycerides)
Kidney function panel test
Liver function blood test panel
Manual urinalysis test with examination using
microscope
Automated urinalysis test
PSA (prostate specific antigen)
Blood test, thyroid stimulating hormone (TSH)
Complete blood cell count, with differential
white blood cells, automated
Complete blood count, automated
Blood test, clotting time
Coagulation assessment blood test
Blood Brother Clinical Laboratories Also Affected by
Price Transparency
Price transparency is also at the center of two federal
lawsuits involving Laboratory Corporation of America (LabCorp) and Quest
Diagnostics. The Dark Report, Dark Daily’s sister publication, reported
on these suits in “Lawsuits
Alleging Overcharges to Proceed in Two Courts in 2020,” December 16, 2019.
The plaintiffs in those cases are uninsured or underinsured
customers who claim they were charged far more for medical laboratory tests
than customers covered by insurance. In both cases, customers were charged at
the chargemaster rates. The plaintiffs contend that the medical laboratories
should have disclosed their rates in advance.
Whichever way this all goes, clinical laboratories will need
to monitor the multiple efforts by the states and the federal government to
make it easy for patients to see the prices of hospital, physician, and other
medical services in advance of treatment. This has the potential to be a disruptive
trend, particularly for hospitals.
Savvy medical laboratory managers conduct internal audits of processes involved in deficiency citations so they can uncover how deficiencies occur and help eliminate recurrences
One trend that places clinical laboratories at risk involves increased regulation of lab processes, along with more thorough accreditation inspections. Compared to past years, both developments mean more ways for lab assessors to find greater numbers of deficiencies.
However, leading laboratory accreditation and quality improvement experts say that many deficiencies could be avoided if lab leaders conducted their own internal audits and continuous quality improvement projects ahead of visits by accrediting authorities.
In an exclusive interview with Dark Daily, Randall Querry, Director of Government Relations at the American Association for Laboratory Accreditation (A2LA) said, “Clinical laboratories can do a better job of preparing for the external assessment by doing an internal audit. That is, watching personnel perform tests and noting if they aren’t following the same sequences that standard operating procedures address before the external assessors arrive.”
“This doesn’t have to be an ‘us against them’ exercise. We are
all in this together for continual improvement and to ensure we’re doing a
better job at the end of each day—that we have had a win,” said Querry
said.
How Should Clinical Laboratories Conduct Internal Audits?
So, what is the best method for clinical laboratory leaders to
conduct their own audits of operations and avoid citations of deficiencies?
Lucia Berte, President of Laboratories Made Better, suggested medical laboratories should “Pick a sequence and follow it through.” In the Dark Daily interview, she suggested labs should focus on:
The sequence of receiving samples in the
laboratory to make certain they are properly accessioned, processed, and
distributed;
Steps to setting up and running an analyzer; and
The process of ensuring tests’ critical values
are reported to ordering clinicians and how reports are made.
An internal audit may suggest areas where the clinical lab
is not on target to meet regulatory and accreditation criteria. Or, the lab may
discover what Querry calls “gray areas”—places where criteria are currently
being met, but a trend suggests there could be problems down the road.
“And in those cases, it’s always good to identify areas of
improvement for preventative action. They may not be a top priority—such as a
deficiency—but the areas are on the radar screen as something to address to prevent
it becoming a worsening problem,” Querry said.
Quality Improvement Processes to Address Deficiencies
Berte notes that citations in one area of the lab may
suggest the need for continuous improvement projects across all laboratory
departments or sections. For example, an accrediting body may cite chemistry
for a deficiency while hematology and other departments do okay. However, that
determination can be deceiving.
“There is always an underlying process. And the better
question for the clinical laboratory is ‘can we make an improvement project out
of this that can solve this problem not only for the area where it was cited,
but perhaps prevent this problem from occurring in other lab [departments]
prior to the next external accreditation assessments?’” Berte said.
Lack of Uniformity among a Clinical Laboratory’s
Departments
Berte says a common deficiency is “lack of a uniform
competency assessment program” for staff throughout the lab. Assessors expect
laboratory departments to have the same competency assessment in regard to
processes, records, and the way documents are created, she explained.
Lucia Berte (above), President of Laboratories Made Better, advises improving quality of documents as a project across the entire lab. “We still have a lot of silo-mentality in labs—where chemistry is different from hematology which is different from transfusion. Labs should have a uniform approach to the way their documents are written, and this is not necessarily the case,” she told Dark Daily. (Photo copyright: Whitehat Communications.)
Competency-related Citations
Berte also said competency-related citations may happen when
documents read by auditors are not in sync with what the officials see in the clinical
lab during inspections. “People not doing things in the order in which things
have to happen. That’s the disconnect.”
Querry, speaking from the perspective of an assessor, adds,
“We see a discrepancy and ask—do they have the appropriate work procedures with
them at the workstation? Is it accessible? Where is this discrepancy? We
identify it and then it’s up to the lab to address it—in training, and between
the written procedure and the process.”
Consistency, he says, is important especially in
organizations where staff rotate among lab areas and different shifts.
Quality System Essentials for Clinical Laboratories
The website for the Clinical and Laboratory Standards Institute (CLIA) states that implementing a quality management system in the lab involves use of “quality system essentials (QSEs).” QSEs are key to lab workflow, communication, and training. They include documents and records management, assessments, and continual improvement.
Querry emphasizes that trying to predict what the hot citations may be in 2020 is not as important as focusing on the technical competence of the lab and its resources.
“We are not out to play gotcha. We are going in there, looking
at all the systems, and doing a sampling of testing in various departments of
the lab. It’s up to the lab to show us it is technically competent to perform
those tests. And they have the equipment and records that the equipment has
been checked and calibrated and maintained. We have an examination process,” he
said.
Experts agree, clinical laboratories that prepare for
external assessments with internal audits and continuous improvement programs
may reduce deficiencies during inspections.
