However, effective communication can bring more harmony to medical lab managers and scientists when it comes to compliance
Depending on how lab professionals view it, clinical laboratory regulations can be characterized as a series of checklists to fill out or an opportunity to grow an organization.
Leaning into the latter option will preserve regulatory compliance while also ensuring the operational health of the clinical laboratory.
At the Lab Manager Leadership Summit, Kelly VanBemmel, MS, MB(ASCP)CM (above) pressed attendees to open the lines of communication between bench scientists and lab managers when it comes to clinical laboratory regulations. (Photo copyright: Scott Wallask.)
‘There’s a Gap’ in How Both Sides View Regulatory Compliance
VanBemmel spent her presentation aiming to bridge the rift between how bench scientists look at clinical laboratory regulations compared to the views of medical lab managers.
“There’s a gap between how staff experience regulations and how management does,” she noted. “Staff typically think of compliance as a checklist to do their jobs.” Managers, however, need to understand a wider compliance picture. She illustrated her point by comparing views on the following regulatory bodies.
Staff understand that the FDA clears tests and devices for use in non-research environments, though not all consumables or equipment are in that setting.
Managers understand that the FDA develops rules and guidance for CLIA complexity categorization.
Communication Leads to Common Ground with Clinical Laboratory Regulations
Given the above differences among managers and staff, VanBemmel explained that both sides must frequently talk to each other to fill in the missing details.
“When you’re in the thick of regulations, communication becomes critical,” she said.
For example, bench staff may feel it is solely their manager’s responsibility to comply with clinical laboratory regulations. Savvy lab leaders will point out non-compliant conditions—such as diagnostic analyzer malfunctions and sample cross contamination—over which bench staff have direct control, helping workers better understand their responsibility when it comes to compliance.
On the other hand, lazy communication from managers to their bench scientists can stunt compliance efforts. She recalled a prior supervisor who often answered questions about regulations by asking: What does the standard operation procedure state?
“That answer wasn’t particularly helpful,” VanBemmel recalled. “That made me think that my supervisor didn’t understand nuance.”
Thorough communication builds greater trust, and seasoned clinical laboratory professionals of all ranks will quickly recognize the compliance benefits when the worker-manager relationship gels.
Program is open to providers that exclusively offer telehealth services, and those providers that offer the telehealth services to other hospitals
In another sign that telehealth is now an established presence in the healthcare marketplace, The Joint Commission recently implemented a new Telehealth Accreditation Program. The initiative, which took effect on July 1, 2024, aims to provide “updated, streamlined standards” enabling “safe, high-quality” delivery of telehealth services to patients, according to a press release. The organization announced the program in April.
Dark Daily has regularly commented on the importance for clinical laboratories to recognize this trend and add the necessary services to meet the expectations and needs of telehealth/virtual doctor visits where the physician orders medical laboratory tests for the patient.
“The use of telehealth in the United States increased 154% during early stages of the COVID-19 pandemic and stabilized at levels 38 times higher than levels in 2019,” said Joint Commission President and CEO Jonathan B. Perlin, MD, PhD, in the press release.
“As telehealth continues to evolve, it was imperative to create a new accreditation program to provide a framework to support the integrity of patient safety regardless of the care setting,” he added.
The accrediting organization is reacting to market demand. Patient and doctor acceptance of virtual doctor visits and telehealth consults is now an established fact.
[PHOTO OF PERLIN HERE]
“Our new Telehealth Accreditation Program helps organizations standardize care and reduce risk so that all patients, including those obtaining services remotely, receive the safest, highest-quality care with outcomes consistent with traditional settings,” said Jonathan B. Perlin, MD, PhD (above), President/CEO, The Joint Commission, in a press release. Clinical laboratory accreditation nationwide is also handled by the not-for-profit organization. (Photo copyright: International Hospital Federation.)
Eligibility
The Joint Commission describes itself as “the nation’s oldest and largest standards-setting and accrediting body in healthcare.” The not-for-profit organization certifies more than 22,000 healthcare providers in the US, according to its website, including hospitals and medical laboratories. Its evaluations are based on surveys in which qualified experts conduct inspections of the facilities to ensure compliance with patient safety and quality standards.
Accreditation is not mandatory, however many states have licensing, certification, or contracting requirements that mandate accreditation by The Joint Commission or other accrediting bodies.
The program is open to providers that exclusively offer healthcare services “via telehealth or remote patient monitoring, with no in-person visits or encounters,” according to The Joint Commission website. This can include organizations that provide:
Primary care, specialty care, or urgent care,
Medical or behavioral consultation,
Remote patient monitoring, and
TeleICU, telestroke, telepsychiatry, or teleimaging services to hospitals.
Hospitals or other healthcare providers can also apply if they have contracts to offer “care, treatment, and services via telehealth to another organization’s patients,” The Joint Commission states. Examples include acute care or psychiatric hospitals that provide telehealth services to other facilities. In this case, the hospitals can obtain telehealth accreditation for the contracted services while maintaining their current accreditation for services provided onsite.
Requirements for Certification
The requirements for accreditation are similar to those in other Joint Commission programs, the organization says. This includes “requirements for information management, leadership, medication management, patient identification, documentation, and credentialing and privileging.”
In addition, it includes requirements specific to telehealth. For example, emergency management requirements have been streamlined to account for services provided remotely. It also contains standards related to telehealth equipment as well as provider and patient education about use of the technology.
“Additionally, the program’s standards may be filtered based on the telehealth modality or service provided,” the organization’s website notes.
Other Accrediting Organizations
The Joint Commission is not the only organization that offers telehealth accreditation or certification. The Utilization Review Accreditation Commission (URAC) provides accreditation programs for telehealth and remote patient monitoring, as well as a certification program for telehealth support services.
The telehealth accreditation program consists of three modules accounting for different forms of delivery:
Provider-to-provider (one provider offers services such as consultation to another provider).
The accreditation process takes up to four months, URAC says.
The Accreditation Commission for Health Care (ACHC) offers what it describes as a telehealth “Distinction” for certain kinds of healthcare providers that it has accredited, including:
Additionally, in April 2022, ACHC announced a telehealth certification program open to “any healthcare provider or organization that delivers health-related services via electronic information and telecommunication technologies,” regardless of whether they are accredited, according to a press release.
“The pandemic really pushed healthcare providers to adopt and grow telehealth services to maintain access for patients and, as a result, many of our clients were seeking ways to optimize this offering in the context of providing quality services,” said program director Teresa Hoosier, RN, in the press release. “ACHC Telehealth Certification establishes national standards. It promotes best practices for digital healthcare services. Certification confirms quality, safety, and consistency—strengthening trust in an organization and assuring patients that they are receiving the best care possible.”
This development is a reminder that clinical laboratory managers need a consumer/patient focused strategy and operational capability to collect specimens and provide medical laboratory tests for telehealth visits when the doctors order tests. It confirms that the trend of consumers/patients using remote healthcare is real, robust, and has legs.
Though data on delays in treatment due to misdiagnosis have been collected by TJC since 2015, misdiagnosis is not listed among the reported top 10 sentinel events
Accurate diagnosis could be the most critical aspect of all
healthcare. Without accurate diagnoses, doctors may be delayed in starting
treatment for their patients. In other cases, ordering inappropriate clinical
laboratory tests might contribute to a misdiagnosis.
SIDM’s analysis revealed that “one in three malpractice cases involving serious patient harm is due to misdiagnosis.” And that, “Cancer, vascular events, and infection account for three-fourths of high-harm, diagnosis-related claims.”
Therefore, it seems odd that misdiagnosis would not be front and center on the latest list of Sentinel Events from The Joint Commission (TJC), the non-profit organization that accredits more than 21,000 healthcare organizations on behalf of the federal Centers for Medicare and Medicaid Services (CMS). Was it omitted? Perhaps not.
What Is a Sentinel Event?
The Joint Commission adopted its formal Sentinel Event
Policy in 1996 as a way to help healthcare organizations improve safety and
mitigate future patient risk. TJC defines a sentinel event as a “patient safety
event that reaches a patient and results in any of the following:
“death,
“permanent harm,
“severe temporary harm, and
“intervention required to sustain life.”
TJC determines healthcare events to be “sentinel” when they
“signal the need for immediate investigation and response.”
Misdiagnosis leading to preventable medical errors would
seem to be a sentinel event, but it is missing from TJC’s list for the past two
years. It’s not, however, missing from an earlier TJC list of preventable
diagnostic errors.
Delay in Treatment Due to Misdiagnosis
A 2015 TJC advisory report on safety and quality issues in healthcare, titled “Preventing Delays in Treatment,” lists misdiagnosis among several reported events that led to delays in diagnosis that then led to patient harm or death.
In that report, TJC defines “delay in diagnosis” as “a
non-optimal interval of time between onset of symptoms, identification, and
initiation of treatment. A delayed diagnosis occurs when the correct diagnosis
is delayed due to failure in or untimely ordering of tests (e.g., [clinical
laboratory] work, colonoscopies, or breast imaging studies). Whether due to
delay in diagnosis, misunderstanding of the disease, misdiagnosis, or failure
to treat, delay in treatment can reduce the number of treatment options a
patient can pursue.”
So, misdiagnosis was, at that time, an event the TJC
collected data on and included in its advisor statements. But since then, it
has been omitted from the list. What changed?
Recent Sentinel Events
Turns out, nothing really. Though misdiagnosis is not listed on TJC’s lists for 2018 and 2019, it is part of a more comprehensive list published by TJC in February titled, “Most Commonly Reviewed Sentinel Event Types.” That report offers more details on the listed sentinel events, and also includes a section drawn from TJC’s 2015 report on delays in treatment, which covers results due to misdiagnosis.
Unanticipated events such as asphyxiation,
burns, choking, drowning or being found unresponsive
Suicide
Delay in treatment
Product or device event
Criminal event
Medication error
Then, in August, TJC release a new report based on the 436 reports of sentinel events TJC received in the first six months of 2019. They include:
Anesthesia-related events
Care management events
Criminal events
Environmental events
Product or device events
Protection events
Suicide—emergency department
Suicide—inpatient
Suicide—offsite within 72 hours (these are
defined in the Sentinel Event Policy)
Surgical or invasive procedure events
Following the release of its March sentinel events list, TJC noted that the components were typical when compared to previous years.
“The trend for the most frequently reported sentinel events remains generally unchanged,” stated Gerard Castro, PhD, MPH (above), Project Director, Patient Safety Initiatives at The Joint Commission, in a PSQH analysis of the Joint Commission’s 2018 list of sentinel events. “Organizations should continue their work toward minimizing risks associated with these types of events, but also strengthen systems and processes that keep patients safe, such as reporting and learning from close calls, teamwork, and improving safety culture.” (Photo copyright: The Joint Commission.)
TJC’s website notes, however, that “fewer than 2% of all sentinel events are reported to The Joint Commission. Of these, 58.4% (8,714 of 14,925 events) have been self-reported since 2005. Therefore, these data are not an epidemiologic data set, and no conclusions should be drawn about the actual relative frequency of events or trends in events over time.”
Might that be because the healthcare organizations in the US
accredited by the Joint Commission are “encouraged” to report sentinel events
and not “required” to do so? This also allows accredited healthcare
organizations to pick and choose which events to report to TJC.
If there is one easy conclusion to draw from all the information presented above, it is that the true rate of misdiagnoses—as well as other types of sentinel events—remains unknown. But what is equally true is that, step by step, the adoption and use of electronic health systems (EHRs), along with other digital tracking modalities, will make it easier for providers and healthcare policymakers to more accurately identify and classify instances of misdiagnoses.
When that happens and better data on misdiagnoses is
available, it will be possible for medical laboratory professionals to use the
methods of Lean
and quality management to collaborate with physicians and other providers. The
first step will be to identify the sources of misdiagnoses. The second step
will be to use these quality improvement techniques to support providers in
ways that allow them to reduce or eliminate the causes of diagnostic errors and
misdiagnoses.
Contrary to CMS and Joint Commission programs implemented in 2017 to reduce them, incidents of hospital-acquired infections have risen for the past few years
Nevertheless, a recent Leapfrog Group report indicates hospitals are finding it increasingly difficult to remove infections all together. This has many healthcare leaders concerned.
The report, which was analyzed by Castlight Health, states that the number of hospitals reporting zero infections has declined significantly since 2015, according to a news release. According to the Leapfrog Group’s report:
Two million people acquire HAIs every year;
90,000 people die annually from HAIs;
HAI costs range from $1,000 to $50,000 depending on the infection.
Hospitals spend $28 to $45 billion annually on HAI costs, Healthcare Finance reported.
“I think it’s far too easy to let something slip, so it’s clear that there really needs to be a renewed focus on getting back to zero. We do still see some hospitals that are getting to zero, so it’s clearly possible,” Erica Mobley (above), Leapfrog Group’s Director of Operations, told Fierce Healthcare. (Photo copyright: LinkedIn.)
Regressing Instead of Progressing Toward Total HAI Elimination
Leapfrog Group’s report is based on 2017 hospital survey data submitted by 2,000 providers. The data indicates that in just two years the number of hospitals reporting zero HAIs dropped by up to 50%. The reported HAIs include:
Central line-associated bloodstream infections (CLABSI) occurring in Intensive Care and other units: 12.7% of hospitals reporting zero CLABSI infections in 2017, down from 25% in 2015;
The remaining infection measures studied by Leapfrog Group had less dramatic decreases over the same time period, according to Fierce Healthcare. Nevertheless, they are significant. They include:
Surgical site infections (SSI) following colon surgery: 19% zero infections compared to 23% previously;
Clostridium difficile (C. difficile) inpatient infections: 3% zero inpatient infections in 2017, compared to 5% in 2015.
Joint Commission Studies Antimicrobial Program Progress
Hospitals have revised their antimicrobial programs, which originally operated on a “top-down” structure, to programs that include clinicians from throughout entire provider organizations;
Health information technology (HIT) can enable real-time opportunities to launch antimicrobial therapy and treat patients; and,
Some barriers exist in getting resources to integrate technology and analyze data.
“These programs used expansion of personnel to amplify the antimicrobial stewardship programs’ impact and integrated IT resources into daily workflow to improve efficiency,” the researchers wrote. “Hospital antimicrobial stewardship programs can reduce inappropriate antimicrobial use, length of stay, C. difficile infection, rates of resistant infections, and cost.”
What Do CMS and Joint Commission Expect?
According to Contagion, while the Joint Commission program is part of medication management, CMS places its requirements for the antimicrobial stewardship program under “infection prevention.”
CMS requirements for an antimicrobial stewardship program include:
Developing antimicrobial stewardship program policies and procedures;
Implementing hospital-wide efforts;
Involving antimicrobial stakeholders for focus on antimicrobial use and bacterial resistance;
Setting evidence-based antimicrobial use goals; and,
Reducing effects of antimicrobial use in areas of C. difficile infections and antibiotic resistance.
Leapfrog Group’s data about fewer hospitals reporting zero infections offers opportunities for hospital laboratory microbiology professionals to get involved with hospital-wide antimicrobial program teams and processes and help their hospitals progress back to zero HAIs. Clinical laboratories, both hospital-based and independent, also have opportunities to contribute to improving the antimicrobial stewardship efforts of the physicians who refer them specimens.
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.
