Representatives from almost 50 different clinical laboratories, professional associations, and societies came together this week to align efforts to expand the supply and retention of qualified laboratory scientists
FORT WORTH, TEXAS—Last week, representatives from a broad cross section of clinical laboratories, lab and pathology associations, public health laboratories, and lab regulatory bodies gathered specifically to identify ways to expand the number of skilled lab professionals.
COLA organized the “Workforce Action Alliance Summit,” a one-day gathering of key clinical laboratory stakeholders who share a common interest in developing initiatives that would directly increase the number of individuals choosing to pursue a career in laboratory medicine.
This is not a new problem, as the lack of trained laboratory scientists across all scientific disciplines has been acute for many years.
Call to Action
In a communication sent to invited participants, COLA’s CEO, Nancy Stratton, and COO, Kathy Nucifora, described the objective of the summit, writing:
“Clearly a call to collective action is required if we are to address the impending clinical laboratory workforce shortage. The past three years have demonstrated the significance of a resilient laboratory infrastructure, not only for the daily care of millions of Americans, but also during the global pandemic. The numerous efforts currently underway to resolve the shortage are unquestionably a component of the solution. Many, however, believe that these efforts are insufficient to close the gap between the projected number of new entrants into the profession, the rate at which those currently in the profession are departing, and the future demand for laboratory testing.”
Robert L. Michel, Editor-in-Chief of Dark Daily’s sister publication The Dark Report was a participant at COLA’S workforce summit. The Dark Report regularly profiles clinical laboratory organizations that have developed innovative and productive initiatives designed to increase the number of students choosing to train as medical technologists (MTs), clinical laboratory scientists (CLSs), medical laboratory technologists (MLTs) and other skilled lab positions.
In materials distributed at the summit, the ongoing gap between demand for skilled lab professionals and the supply was illustrated thusly:
“The US Department of Labor estimates 320,000 bachelors and associates degreed laboratory professionals are working in the United States. If each of those professionals worked a standard 40-year career, the natural annual attrition of 2.5% would require 8,000 new professionals to maintain their current numbers. This exceeds the current output of accredited educational programs by more than 1,000 annually.”
Case Studies of Success
Over the course of the day, participants at the summit heard about the successes of certain laboratory organizations designed to get more students into training programs, supported by the educational courses required for them to become certified in their chosen area of laboratory medicine. These case studies centered around several themes:
Obtaining funding specifically to establish an MT/CLS training program to increase the number of candidates in a region. One example involved ARUP Laboratories and its success at working with a local Congressional representative to get a $3 million federal grant funded as part of a larger legislative package.
The medical laboratory scientist (MLS) program at Saint Louis University (SLU) worked with Quest Diagnostics to launch an accelerated bachelor’s degree program. The 16-month program combines online academic courses with intensive hands-on learning and clinical experiences in Quest’s Lenexa, Kansas, laboratory. The first students in this accelerated degree program began their studies in the spring semester of 2023.
During the afternoon, working groups addressed ways that lab organizations can collaborate to increase recruitment and retention of laboratory scientists across all disciplines of lab medicine. This input was synthesized into action planning for the three priorities that can lead to expanding the lab workforce.
By day’s end, several working groups were organized with specific next steps. COLA is taking the lead in managing this initiative and giving it momentum. All clinical laboratory professionals and pathologists are welcome to participate in the Workforce Action Alliance (WAA). Anyone wishing to learn more can contact COLA by clicking here, calling 800-981-9883, or by visiting https://education.cola.org/contact-us-page.
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
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
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
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.
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
Experts agree, clinical laboratories that prepare for
external assessments with internal audits and continuous improvement programs
may reduce deficiencies during inspections.
All labs face the challenge of coping with shrinking budgets and staffing shortages, which is why coaching, management observation, and continuous improvement initiatives are proving helpful to medical laboratories
It’s the biggest generational shift since baby boomers began working in clinical laboratories and anatomic pathology groups. Across the nation, labs are watching their most experienced and knowledgeable medical technologists and other lab scientists retire. The need to train their replacements while maintaining peak productivity and controlling costs is motivating lab leaders to adopt powerful new management methods.
Innovative lab administrators and pathologists recognize that automation and the ability to leverage the increasing amounts of data produced by today’s innovative diagnostic technologies and assays can only go so far in helping to compensate for declining revenues.
This is why one trend is quietly gaining momentum. There are many medical laboratories, pathology groups, and other diagnostics providers working to help their lab staffs create a culture of continuous, meaningful improvement. The stakes are great. Not only is this essential for financial sustainability, it can be the source of competitive advantage with physicians, patients, and payers in today’s increasingly competitive diagnostic market.
This is why many medical laboratories are turning to continuous improvement systems such as Lean to increase personnel skills, reduce waste, and make the most out of shrinking budgets and margins. Yet, without a solid foundation of staff trained in these methods and a framework of processes to encourage improvement, lean laboratory managers often struggle to see consistent, significant improvements.
Optimizing Staff Performance and Developing Improvement Processes with Coaching and Management Observation
Performance Coaching and Management Observation offer powerful tools for laboratory managers to reinforce improvement efforts. They encourage the success of personnel, leverage existing personnel to meet growing demands while maintaining service levels, and establish an effective foundation for Lean execution.
Benefits of effective coaching and management observation sessions for laboratories include:
Enhancement of laboratory manager performance and skills;
Improved retention of skilled labor and consistent improvement of personnel skills through individualized assessment and improved communication;
Establishing a method of creating and maintaining a culture of continuous improvement, while empowering staff across all levels of lab operations; and,
Creating a competitive edge on laboratories struggling to implement Lean processes and other optimizations in response to increased workloads, reduced staff, and tighter budgets.
Stephen Stone (left), Managing Director, Argent Global Services, and, Rita D’Angelo, PhD (right), President and CEO, D’Angelo Advantage, spoke at Lab Quality Confab in 2018 on the benefits of coaching and management observation sessions for clinical laboratories and implementing continuous improvement systems using Lean Production Methods. (Photo copyright: Dark Daily.)
“While many laboratories are familiar with management observation because of competency testing, few laboratories use coaching and management observation as part of their Lean efforts.” Stephen Stone, Managing Director at Argent Global Services told Dark Daily. “Coaching and management observation offers laboratories an effective means to not only increase throughput using existing staffing and encourage sustainable growth, but also increase retention of existing skilled personnel and reduce hiring costs.”
Lab Supervisor Retirements Projected to Exceed Staff Retirements
Of possibly greater concern, he goes on to point out, is that projected retirement rates for supervisors are higher than those of staff. This means laboratories which fail to focus on staff development and retention could face further issues in both leadership and staffing shortages should trends continue.
“Investing in and empowering your staff will improve productivity, improve quality, improve safety, and help laboratories to work toward goals as a cohesive team,” Rita D’Angelo, PhD, President and CEO at D’Angelo Advantage, LLC, told Dark Daily. “As a result, costs and waste drop significantly. Coaching and management observation alongside a culture of continuous improvement can help labs to overcome many of the staffing and budget obstacles faced today.”
The webinar will include essential coaching skills to help laboratory managers pass on the skills to serve as Lean champions to personnel and establish the foundation and structure for a lasting culture of improvement within the laboratory.
C-Level laboratory leadership, laboratory directors, managers and supervisors, and key members of continuous improvement teams also can use the interactive Q/A session following the webinar to gain answers to questions and concerns directly facing their laboratories’ efforts to develop continuous improvement processes or implement Lean methodologies.
(To register for this critical Jan. 16th webinar, click here. Or, copy and paste this URL into your browser: https://www.darkdaily.com/webinar/performance-coaching-and-management-observations-to-improve-productivity-and-efficiency-strengthening-the-skills-of-management-to-execute-a-lean-lab-transformation-2-2/.)
Although the Clinical Laboratory Improvement Amendments (CLIA) requirements have not undergone major changes since debuting in 1992, the medical laboratory industry has become more complex and technology-laden, resulting in old rules being applied to emerging technologies.
“People can get lulled into this sense that we know what standards are and we’re meeting them, but what has happened is the rules haven’t really changed—the industry has,” says Nora L. Hess, MBA, MT(ASCP), Senior Consultant for Accumen, a lab quality improvement company in San Diego, CA. “Technology is now jumping ahead so fast that keeping up with it and understanding how the rules are going to be applied is challenging.”
Anne T. Daley, MS, CMQOE, CSSBB, CLC, MT, DLM (left), and Nora L. Hess, MBA, MT(ASCP), PMP (right), are Senior Consultants with Chi Solutions, an Accumen company. Together, they have extensive first-hand experience guiding clinical laboratories through the rigid and rigorous process of achieving inspection-ready status. (Photo copyrights: Chi Solutions, Inc.)
Why being ‘Inspection Ready’ Can Improve Performance and Increase Revenue
Striving to be “inspection ready” should be the goal of every clinical laboratory and pathology group. However, Daley notes labs typically operate with staffs that are stretched thin by retirements, illnesses, staff shortages, or ancillary demands on administrators’ time, caused by system-wide initiatives that range from electronic health record (EHR) rollouts to integration and consolidation of other labs.
“Most hospital laboratories are staffed at a level where they are working hard just to meet the daily patient care needs,” Daley says. “You add in all these additional projects and something has to give.”
In today’s challenging environment, Hess says laboratories that consistently perform well during the inspection process share several characteristics, including the following:
a culture of quality across the laboratory; and,
an emphasis on inspection readiness.
“They make inspection readiness a consistent focus across the entire laboratory,” Hess notes. “It becomes part of the calendar. It becomes part of what they talk about all the time. It is a part of their decision-making. It is hardwired into who they are and what they do … successful laboratories are making this part of their day-to-day activities, so it doesn’t get lost in the shuffle and it doesn’t get back-burnered.”
Hess and Daley note the types of deficiencies cited by accreditation agencies tend not to vary much from year to year. Testing personnel competency and proficiency testing are common themes, annually ranking high on top-10 lists of deficiencies found. However, laboratory directors increasingly are being singled out for issues related to qualifications and performance of responsibilities.
(To register for their Dec. 13th webinar or to order a DVD, click here. Or, copy and paste this URL into your browser: https://www.darkdaily.com/webinar/make-your-lab-assessment-ready-in-2019-know-the-most-common-deficiencies-in-accreditation-and-certification/).
Research conducted by Kalorama suggests the popularity of retail clinics represents a trend towards newer healthcare models that challenge existing models of care, and which could severely impact hospitals, clinical laboratories, and pathology groups
In recent years, pathologists and medical laboratory managers have watched as retail clinics housed in drug and grocery stores became a go-to service for healthcare customers seeking relief from minor illnesses. However, to market research company Kalorama, retail clinics also are a “game-changer” that could pose a threat to healthcare providers if their growth remains unchecked.
At risk are health systems and office-based physicians, along with the clinical laboratories and pathology groups that serve them. This would happen if patients shy away from primary care doctors in favor of cheaper, faster, medical care. However, as retail clinics expand the services they provide, they also could become an important source of orders for certain types of medical laboratory tests.
Kalorama defines retail clinics as, “healthcare centers that provide basic and preventative care in a retail setting; excluded are crisis and acute care centers; urgent care centers; emergency facilities; and wellness centers.” According to Kalorama’s data, “in 2016, total US retail clinic sales are estimated at more than $1.4 billion, an increase of 20.3% per year from $518 million in 2010.”
This increased use of retail clinics is a mixed blessing. On one hand, easy accessibility, low-wait times, and flexibility combined with lower costs for basic care is a boon for certain patients. On the other hand, this emergent healthcare model requires that traditional healthcare facilities address the impact of retail clinics on traditional practices, patient care, and regulatory standards.
Here are five reasons why retail clinics could threaten traditional healthcare models:
Retail Clinics Disrupt the Normal Healthcare Delivery Environment
Retail clinics are designed for immediate treatment of symptoms and vaccinations, not in-depth examination or long-term healthcare relationships between physician and patient. However, because retail clinics are a convenient low-cost option for patients, they become direct competition for full-service. Why visit a primary care physician (PCP) when you can receive off-hour care at lower prices and with faster wait times?
Based on data from peer-reviewed journal Mayo Clinic Proceedings, the graph above illustrates the huge growth of retail clinics over just the past 10 years, which is expected to continue. (Image copyright: Accenture Consulting.)
There is a rising fear among PCPs that the quick fix of retail clinic services will translate into poorer overall health for patients who fail to establish permanent long-term healthcare connections. This fear is validated by an American Medical Association (AMA) report that states, “only 39% of retail clinic users report having an established relationship with a primary care physician, which contrasts to about 80% of the general population reporting such a relationship.”
Retail Clinics Increase Competition for Primary Care Practices
Rather than competing with emergency departments, retail clinics directly compete with primary care clinics, according to Kalorama and the AMA. Staffed primarily by nurse practitioners and physician assistants, retail clinics treat symptoms of acute and easily identifiable health issues. There is growing concern that this limits opportunity for patients to receive more comprehensive healthcare that includes identification and treatment of chronic diseases.
And though competition in the healthcare market is good, physicians worry that retail clinics may push smaller stand-alone clinics out of business. The Kalorama report explains that “ultimately, medical practices are businesses that rely upon a steady flow of [patients] for their success.” When primary care facilities close due to loss of patients, it can create immediate healthcare gaps in communities.
Retail Clinics Could Increase Strain on Medical Laboratories and Pathology Groups
Kalorama’s data shows that retail clinics could place strain on medical laboratories and pathology practices. The study notes, “retail clinics are becoming relatively large users of point-of-care (POC) tests, clinical chemistry, and immunoassay laboratory tests and vaccines.” Kalorama’s report states, “the combined sales of these three types of products to retail clinics reached $240 million” in 2015, reflecting a 26% per year growth in testing since 2010. Projections from Kalorama suggest further increases in retail clinic test ordering in years to come.
The COLA newsletter also warns that pathologists and clinical laboratory managers “should expect to see, over time, a steady increase in the menu of diagnostic testing offered by retail clinics.” COLA suggests that pathologists and laboratory scientists will experience increased demand from retail clinics for their services and expertise, but that because retail clinics often require high-volume, fast-paced testing without the benefit of full clinical laboratories (both in terms of staff and equipment) there is potential for retail clinic testing to fall short of industry standards.
Retail Clinics Fragment Health Records
According to an article in AMA Wire, the AMA House of Delegates (HOD) established guidelines for retail clinics that focus on continuity of medical records and the safeguarding of patient care. The guidelines state that retail clinics “must produce patient visit summaries that are transferred to the appropriate physicians and other healthcare providers in a meaningful format that prominently highlights salient patient information.” The fear, according to the AMA, is that the fragmenting of medical records may bring harm to patients via miscommunication that undermines patient-physician relationships and complicates oversight in treatment plans.
The Kalorama report echoes this sentiment. It states that physicians often take a negative view of retail clinics because of the lack of communication between retail clinics and primary care practices, citing a lack of cooperation or “unwillingness or inability on the part of convenience clinics to share medical information about patients with primary care providers.”
Retail Clinics Are Expanding Their Reach
Despite the fact that the AMA Council on Medical Services 2017 report on delivery reform recommends that retail clinics limit the scope of their care, expansion of retail clinic services has gone unchecked in many areas according to the Kalorama report. AMA policy states that retail clinics must have a “well-defined and limited scope of clinical services,” and the AMA’s 2017 guidelines state that “retail health clinics should neither expand their scope of services beyond minor acute illnesses … nor expand their scope of services to include infusions or injections.”
As retail clinics open around the country and expand their offerings there is a call for increased regulation of retail clinics to check that growth. COLA states that retail clinics are positioning themselves to play a major role in the delivery of primary care services. And the Kalorama report suggests that the trend towards retail clinic use will continue to rise, creating both challenges and opportunities for providers, clinical laboratories, pathologists, and healthcare policy makers who will be required to address the disruption to their businesses.