Dettwyler is set to retire at age 92 after a long career helping clinical laboratories with their coding and billing systems
When William Dettwyler, MT, began working in a clinical laboratory, Harry Truman was president of the United States and scientists had not yet discovered the structure of DNA. Now, as he approaches his 92nd birthday in March, he is finally ready to retire from a career that has spanned more than seven decades, from bench work as a medical laboratory technician (MLT) to assisting labs with their medical coding and medical billing challenges.
Along the way, one of his coding innovations helped the State of Oregon save substantial sums in its Medicaid program. He also helped many medical laboratories increase reimbursement by correcting their coding mistakes. This from someone who left school after eighth grade to help on his family’s farm in rural Oregon.
In an exclusive interview with Dark Daily, Dettwyler discusses his long career and offered pointers for labs on improving their coding and reimbursement procedures.
Back in the 1980s, when he began his consulting work for labs, “they were very poor at billing,” he recalled. “Hospital billing staff didn’t understand lab coding. Reference laboratories didn’t do a good job of picking the right codes or even billing all the codes. Up until around the 1970s, hospitals didn’t even have to bill individual lab procedures with CPT codes. They billed with a revenue center code for all their lab services.”
These days “people are much more sophisticated,” he notes. “There are fewer coding problems compared to what it was in the 1980s and 1990s up to the 2010s.” However, he says he still has a handful of clients who call on his expertise.
“It was not unusual to go to a large university medical center and in three days tell the CFO on my exit review that the following year their lab would bring in about a half million more in revenue, just from my coding review. But I did not reveal to them that I had only gone to the eighth grade in a little one room school and was the lone graduate in my eighth-grade class,” wrote William Dettwyler, MT (above), owner of Codus Medicus in Salem, Ore., in an article he penned for Medical Laboratory Observer. For 75 years Dettwyler worked in the clinical laboratory industry. For much of that time he helped labs all over America improve their coding and reimbursement systems. (Photo copyright: LinkedIn.)
How It All Began
Dettwyler got his first taste of lab work in the early 1950s as a teenager washing glassware for a medical laboratory technician at a local medical practice. A few years later he completed an MLT program at Oregon Institute of Technology in Klamath Falls and landed his first lab tech job at a clinic in Portland.
His entry to consulting came in the early 1970s while he was working for a medical group in Salem. “I was helping the accounting personnel with their billing and noticed that Medicaid was not paying for a common test for syphilis that I was performing,” he recalled. “I contacted Medicaid, and they told me they didn’t understand laboratory procedures.”
After that, “they started to call me frequently with laboratory questions,” he said. “It wasn’t long before they asked me to help them on a part-time basis.” He also assisted with questions related to radiology.
By 1976, Dettwyler was devoting 35 hours a week to assisting the state Medicaid agency while still working as a lab tech.
Simple Hack Ends Overpayments
One of his career highlights came around 1981, when he discovered that the agency was overpaying for some pathology and radiology procedures by as much as 200%.
“Pathologists and radiologists are paid based on whether they are performing the complete procedure—the technical component and the professional component—or just the professional component, where they interpret the results,” he explained.
When billing for just the professional component, the physicians would add two digits to the standard code, so it might come in as 88305-26. However, the state’s computer system could only accommodate a five-digit code, so the state was paying as if the providers had done everything.
“The computer techs said the software couldn’t handle a seven-digit number in a five-digit box, so I devised a way for the computer to read the equivalent of seven digits,” he recalled.
His solution was to modify the codes so that the last digit was an alphabetic character. Instead of billing for code 88305-26, the physicians would bill for 8830F, and the state would pay them correctly.
Around that time, Dettwyler also began assisting a Medicare office in Portland. This forced him to cut back on his work as a lab tech. But he still worked around 60 hours a week.
“For most of my life, I’ve worked three jobs,” he said. “Work is my hobby.” He also had a large family to support—by 1976, he and his wife had 10 kids.
Transition to Lab Consulting
In 1986, the state was facing a budget shortfall and cut its Medicaid consultants, so Dettwyler decided to seek consulting work with labs while continuing to work at the bench.
“I really liked the coding because I had very little competition,” he said. “But I wanted to keep working in the laboratory mainly to understand the problems.”
While working for the state, Dettwyler attended coding seminars and workshops. He noticed that labs were losing revenue due to poor billing practices. “They didn’t understand all the coding complexities, so they really hungered for this kind of assistance.”
But first, he had to find clients. So he partnered with another lab tech who was offering similar consulting services.
Business picked up after Dettwyler contributed an article to the trade publication Medical Laboratory Observer about his process, which he calls “procedure code verification and post payment analysis.”
“That went like gangbusters,” he said. “We started getting calls from all over the country.”
Dettwyler later split from his partner and went to work on his own.
“I would sit down with the person who was responsible for coding, usually the lab or radiology manager,” he explained. “We would go over the chargemaster and cover every procedure to make sure the code and units were correct. When I was done, I would give them a report of what codes we changed and why we changed them.”
Beginning in 1989, he signed on as a contractor for another consultancy, Health Systems Concepts on the East Coast, where he remained until 2019.
Advice to the Current Generation
What is Dettwyler’s advice for someone who wants to follow in his footsteps and assist labs with their coding? “I wouldn’t recommend it now,” he said. “There’s less need for that kind of assistance than in the past.”
However, he does find that labs still run into problems. The greatest need, he says, is in molecular diagnostics, due to the complexity of the procedures.
In addition, labs are sometimes confused by coding for therapeutic drug monitoring, in which a doctor is gauging a patient’s reaction to a therapy versus screening for substance abuse. “Those issues are often misunderstood,” he said.
Microbiology also poses coding challenges, he noted, because of the steps required to identify the pathogen and determine antibiotic susceptibility. “It requires quite a bit of additional coding,” he said. “Some labs don’t understand that they can’t just bill a code for culture and sensitivity. They have to bill for the individual portions.”
Labs that work with reference labs also have to be careful to verify codes for specific procedures. “I’ll review the codes used by reference labs and, surprisingly, they’re not always correct. Reference labs sometimes get it wrong.”
If someone does want to become a coding expert, Dettwyler suggests that “they should first have experience as a lab tech, especially in microbiology, because of the additional coding. And they should try to work with somebody who is already doing it. Then, they should work with the billing department to learn how it operates.”
He also advises clinical laboratory managers to follow the latest developments in the field by reading lab publications such as The Dark Report. “You have to do that to keep current,” he said.
Despite never completing high school, Dettwyler eventually received his GED and an associate degree. “But the degrees didn’t really help me,” he said. “Much of it was on-the-job training and keeping my eyes open and listening.”
Clinical laboratories are particularly tasty targets for cybercriminals seeking the abundance of protect health information contained in patient electronic health records
Recent data from cybersecurity company Netwrix of Frisco, Texas, shows that 84% of healthcare organizations—including clinical laboratories and pathology groups—caught at least one cyberattack in the past year and “69% of them faced financial damage as a result.” That’s according to the company’s latest Hybrid Security Trends Report which notes that 24% of healthcare organizations are “fully cloud-based,” as opposed to just 11% of non-healthcare industries.
“Phishing was the most common type of incident experienced on premises, similar to other industries. Account compromise topped the list for cloud attacks: 74% of healthcare organizations that spotted a cyberattack reported user or admin account compromise,” the Netwrix report notes.
Phishing, where cybercriminals send fake emails and texts to unsuspecting employees that trick them into providing private information, continues to be one of the most prevalent cyberthreats experienced by healthcare organizations and often serves as the catalyst for much larger and more dangerous cyberattacks.
This is particularly dangerous in clinical laboratories where as much as 80% of protected health information (PHI) in patients’ electronic health records (EHRs) is laboratory test results and other personal medical data.
“Protected health information (PHI) is one of the most expensive types of data sold on darknet forums, which makes healthcare organizations a top target for cybercriminals, said Ilia Sotnikov (above), security strategist and VP of user experience at Netwrix, in the report. Clinical laboratory patient electronic health records are particularly weighted toward PHI. (Photo copyright: Netwrix.)
Don’t Open That Email!
Typical phishing scams begin with innocent-looking emails from companies that appear to be legitimate and often contain language that implies urgent action is needed on the part of the user. These emails can be very convincing, appear to originate from reputable companies, and usually instruct users to open an attachment contained in the email or click on a link that goes to a known company website. However, the site is a fake.
Once the harmful file attachment is opened, users will be directed to download fake software or ransomware that attempts to capture the user’s personal information. When visiting a malicious website, consumers will often receive pop-ups with instructions for updating information, but the true purpose is to harvest personal data.
Never provide any personal information to an unsolicited request.
If you believe the contact is legitimate, initiate a contact with the organization using verified data, usually via telephone.
Never provide any passwords over the phone or in response to an unsolicited Internet request.
Review any accounts, such as bank statements, often to search for any suspicious activity.
“Healthcare workers regularly communicate with many people they do not know—patients, laboratory assistants, external auditors and more—so properly vetting every message is a huge burden,” said IT security expert Dirk Schrader, VP of security research at Netwrix, in the report. “Plus, they do not realize how critical it is to be cautious, since security awareness training often takes a back seat to the urgent work of taking care of patients. Combined, these factors can lead to a higher rate of security incidents.”
Top 10 Brands Faked in Phishing Scams
Phishing emails often appear to be from legitimate companies to lull the recipient into a false sense of security. In a January 22 report, Check Point Research (CPR) announced its latest Brand Phishing Ranking for the fourth quarter of 2024. The report reveals the brands that were most frequently impersonated in phishing attacks by cybercriminals for the purpose of stealing personal information from consumers.
According to the CPR report, 80% of disclosed brand phishing incidents occurred within just 10 brands (listed below with each brand’s percentage of phishing attacks). They are:
According to the report, fraudulent domains “replicated official websites to mislead shoppers with fake discounts, ultimately stealing login credentials and personal information. These fraudulent sites replicate the brand’s logo and offer unrealistically low prices to lure victims. Their goal is to trick users into sharing sensitive information, such as login credentials and personal details, enabling hackers to steal their data effectively.”
Steps Clinical Labs Can Take to Protect Patients’ PHI
Clinical laboratories and pathology groups can take precautions that minimize the risk of allowing cybercriminals access to their patients’ PHI.
“A core defense strategy is to minimize standing privileges by using a privileged access management (PAM) solution. Another is to implement identity threat detection and response (IDTR) tools to quickly block malicious actors using compromised credentials,” said Ilia Sotnikov, security strategist and VP of user experience at Netwrix, in the report.
The threat of phishing scams is a lingering issue that everyone in healthcare should be aware of and take necessary precautions to recognize and prevent having one’s PHI stolen. Clinical laboratory management should constantly remind lab personnel and contractors to be vigilant regarding fake emails and texts from well-known brands that ask for private information.
Legal actions highlight ongoing concerns about payer behavior and included a record-breaking settlement in antitrust case against Blue Cross and Blue Shield
Several high-profile federal lawsuits filed last year, along with settlements in older cases, demonstrate that providers, patients, and self-insured employers—including hospitals, clinical laboratories, and anatomic pathology groups—continue to have serious concerns about lack of transparency and certain business practices of health plans.
Self-Insured employers are suing because they cannot see their data and discovered their health plans overpaid providers from allowed charges (meaning a self-insured employer has greater health benefit costs).
Providers are suing because they are being paid less than agreed and have claims denied for spurious reasons.
These lawsuits show that there is increasing ill will and concerns by self-insured employers and providers as to how health insurers are properly conducting business.
Below is a rundown of the cases.
“Over the past 12 years we have dedicated an extraordinary amount of time, tireless effort, and resources to this historic outcome for providers,” said Co-Lead Counsel Edith Kallas, JD, of Whatley Kallas, a press release. The Blue Cross and Blue Shield Association settlement with healthcare providers is the largest healthcare-related antitrust settlement in US history, according to plaintiff’s attorney Whatley Kallas, LLP. Clinical laboratories and pathology groups can learn from these lawsuits. (Photo copyright: Whatley Kallas.)
BCBSA Settles Long-Running Antitrust Case
In October, the Blue Cross and Blue Shield Association (BCBSA) and the 33 independent Blue Cross and Blue Shield (BCBS) plans agreed to a $2.8 billion settlement in a 12-year-old federal antitrust lawsuit. Co-counsel for the plaintiffs Whatley Kallas, LLP, described the agreement as the “largest antitrust settlement in the history of the United States healthcare industry.”
Healthcare providers alleged that the BCBS plans had agreed “to allocate markets through the use of exclusive service areas and to fix the prices paid to providers through the BlueCard Program,” according to a news release.
In addition to the cash payment, the health plans also agreed to “invest hundreds of millions of dollars in system improvements for the benefit of providers,” the law firm noted, adding that the settlement would compel changes in how the plans “process claims, communicate with, and make payments to healthcare providers,” helping to “address resource-draining administrative burdens and inefficiencies currently experienced by providers.”
Whatley Kallas said the settlement would ultimately result in injunctive relief amounting to $17.3 billion during its first 10 years.
“Many important issues for providers are finally being addressed,” said Edith Kallas, JD, of Whatley Kallas in the news release. “We’re pleased that we have been able to achieve relief that will create a better system for healthcare providers and that will support the organizations and people we rely on to take care of us and our families every day.”
BCBSA also issued a statement: “This settlement ends a long-running legal challenge to the Blue Cross Blue Shield Association license agreements and related rules. We deny the allegations made in the lawsuit. However, to reach a settlement and put years of litigation behind us, we have agreed to make some operational changes and a monetary payment to the provider class involved in the case.”
As explained in court documents, plaintiff Sandra M. Peters was covered by an ERISA plan self-funded by Mars Inc. and administered by Aetna. The latter contracted with Optum to provide access to physical therapy, occupational therapy, and chiropractic services.
Peters alleged that Aetna, in collusion with Optum, fraudulently disguised the latter’s administrative fees as medical costs.
“These misrepresentations serve as the cover that allows Aetna to illegally (i) obtain payment of the Subcontractors’ administrative fees directly from insureds when the insureds’ deductibles have not been reached; (ii) use insureds’ health spending accounts to pay for these fees; (iii) inflate insureds’ co-insurance obligations using administrative fees; (iv) artificially reduce the amount of available coverage for medical services when such coverage is subject to an annual cap; and (v) obtain payment of the administrative fees directly from employers when an insured’s deductible has been exhausted or is inapplicable,” stated her original complaint, filed in 2015 in the US District Court for the Western District of North Carolina.
On Nov. 6, attorneys for Peters notified the court that they had settled the case. A month later, Optum said it had withdrawn from the settlement and was prepared to go to trial. Then, the parties appeared to resolve their remaining differences, and Peters’ attorneys filed notice on Dec. 17 that they had once again settled, Mealey’s reported. Terms of the settlement were not disclosed.
Owens and Minor Alleges Mismanagement of Self-Funded Plan
As reported by The Dark Report and various news outlets, Owens and Minor, a healthcare logistics company, filed a lawsuit in November against Anthem BCBS of Virginia, which had been administering Owens’ self-funded employee health plan since 2017.
The complaint further stated that “Defendant acted contrary to the fiduciary standards imposed by ERISA by, among other things, (i) paying more for healthcare claims than was even billed, (ii) securing kickbacks from providers, (iii) double-paying claims, and (iv) pocketing rebates belonging to Plaintiff.”
Owens initially requested plan data from Anthem in September 2021, but Anthem refused to do so, the complaint stated. “Eventually, Plaintiff had to sue Defendant to obtain its own data. Now that Plaintiff has a portion of that Plan data and has had the opportunity to analyze it, it is clear why Defendant fought so hard to prevent Plaintiff from accessing it.”
Becker’s Payer Issues noted that the lawsuit “reflects a wider legal trend for employers and health plan administrators navigating ERISA requirements. Under the law, plan fiduciaries must act in the best interests of beneficiaries by seeking the lowest reasonable costs for services. Recent amendments, such as the Consolidated Appropriations Act of 2021, have heightened transparency requirements, leaving employers with new tools—and new pressures—to ensure compliance.”
DOJ Alleges Overcharges Related to Military Managed Care
On March 13, the US Department of Justice (DOJ) announced that it had sued six health plans that participate in the Uniformed Services Family Health Plan (USFHP) program, which provides health benefits to military retirees and their families. The government alleged that the plans were aware of calculation errors that had inflated payment rates by more than $300 million between 2008 and 2012.
“The Plans failed to report or return any of those overpayments and, in fact, continued submitting claims to the government at the improperly inflated rates for several more months,” the complaint states.
Shortly after filing the lawsuit, US Family Health Plan Alliance issued a statement describing the allegations as “meritless,” Becker’s Payer Issues reported. The group said that the plans and the government had “expressly negotiated [payment rates] in a fixed-rate contract more than 10 years ago.”
These developments are clear signals in the market that self-insured employers, along with providers—including physicians, hospitals, and medical laboratories—have growing evidence that certain health insurance companies are gaming the system and not paying claims according to contractual arrangements. Expect to see more lawsuits against health plans, particularly by self-insured employers because, for them, the sums involved can be in the tens of millions of dollars.
Judge decides injuries claimed by pathologists are not antitrust injuries and that plaintiffs have no standing to bring antitrust lawsuit
Four pathologists who filed an antitrust lawsuit alleging their former employer “engaged in a series of unfair and deceptive practices” in an effort to maintain a monopoly on clinical pathology services in central Iowa had their lawsuit dismissed by a federal judge. The plaintiffs appealed the decision. Two related state lawsuits are still pending, one in which the plaintiffs are the defendants.
It is common for pathologists in a community to leave one pathology practice and either establish a new practice or join a nearby practice. What is less common is litigation that involves the original group practice and the departed pathologists.
Thus, this example of lawsuits and counter lawsuits is interesting because it creates court rulings about the strengths and weaknesses of the arguments asserted by both plaintiffs and defendants in situations where pathologists leave their employer but continue to practice in the same community.
The court decisions in these cases demonstrate how judges are handling these issues involving antitrust allegations, market share, and non-compete agreements.
“As a result of Defendants’ alleged conduct, Goldfinch asserts its ability to compete has been severely undermined and ‘has the potential to harm patients,’” wrote federal judge Rebecca Goodgame Ebinger, JD (above), in her order granting defendants’ motion to dismiss. “These injuries are not antitrust injuries because they do not stem from conduct affecting competition in the pathology and dermatopathology markets generally.” Clinical laboratories and anatomic pathology practices can learn from the decisions handed down in this court case. (Photo copyright: Wikipedia.)
Pathologists Accuse Defendants of Suppressing Competition
In their original complaint, which was filed May 13, 2024, in the US District Court for the Southern District of Iowa, the plaintiffs said that, beginning in 2021, IPA “strongly pressured” them to sign an employment agreement that would have prevented them from launching a competing practice in the Des Moines area. They refused to comply, but “the administrator of these corporations told these pathologists that the Agreement was in effect even though they had not signed it,” the complaint states.
On October 2022, they informed IPA that they intended to leave to form their own pathology practice, according to the complaint.
The new practice, Goldfinch Laboratory in Urbandale, Iowa, began offering pathology services in February 2023.
“Prior to the formation of Goldfinch, IPA was the only independent pathology practice in central Iowa that was not exclusively tied to one source of referrals,” the complaint states. In addition, “it was the only independent pathology practice in central Iowa that offered dermatopathology services.”
After they notified IPA and RLC of their intention to leave, the plaintiffs alleged that the employer engaged in a series of efforts to “suppress competition” and monopolize the local market for pathology and dermatopathology services.
Plaintiffs Allege Defendants’ Behavior Could Have Harmed Patients
The pathologists were barred from entering IPA’s offices, leaving potential referring physicians with the impression that “these pathologists were no longer practicing,” the complaint states, and preventing them from “maintaining on-going relations with potential referral sources.”
IPA, the complaint alleges, “refused to share biopsy slides with Goldfinch pathologists when those slides were required for continuity of care of the patient—even though this practice was contrary to the standard of care and could well have caused harm to patients.” The complaint characterized this as “an effort to induce referral sources not to make referrals to Goldfinch.”
The plaintiffs also alleged that IPA and RLC made “false and deceptive statements to dissuade referral sources from making referrals to Goldfinch,” for example by claiming that legal problems would force the practice to close.
Given their “monopoly power” in the local market, the plaintiffs argued, IPA and RLC “were able to charge supracompetitive prices for their services.” A $1.4 million contract with one hospital corporation was “in the top 5% of Part A contracts in the United States,” the complaint alleges, and rural hospitals paid “at least 400% of the actual Medicare fee schedule amount for the technical component of pathology services for Medicare patients.”
Defendants’ Response to Allegations
In their motion to dismiss the suit, the defendants argued that Goldfinch was “a classic ‘disgruntled competitor’” that had not demonstrated an “antitrust injury” as defined by federal and state law.
“Goldfinch’s owners used to work for IPA and RLC, voluntarily left, and now seek to litigate their personal financial losses under the guise of federal and state antitrust claims,” the motion states.
The defendants also argued that Goldfinch lacked standing to file an antitrust claim.
Goldfinch “alleges the ‘antitrust practices’ of IPA and RLC are harmful to patients and other payers for pathology and dermatopathology services,” the motion states. “But patients and payers are quite capable of noticing and seeking redress for the alleged harms and Goldfinch need not do so on their behalf.”
In addition, the defendants argued, Goldfinch failed to adequately define a “plausible” product market or geographic market that was subject to the alleged monopoly power.
“Goldfinch’s alleged geographic market is vaguely ill-defined as ‘central Iowa,’” the motion states. “But there is a difference between the service area and a geographic market.” The motion cited an earlier decision in which the US Court of Appeals for the Seventh Circuit “deemed a relevant market for a pathology practice to be nationwide.”
“As a result of Defendants’ alleged conduct, Goldfinch asserts its ability to compete has been severely undermined and ‘has the potential to harm patients,’” she wrote. “These injuries are not antitrust injuries because they do not stem from conduct affecting competition in the pathology and dermatopathology markets generally. These injuries, instead, are a result of Defendants’ alleged actions targeting Goldfinch and demonstrate an injury to Goldfinch as a competitor—the loss of some patients and referral sources.”
She also agreed with the defendants that Goldfinch lacked sufficient standing to bring an antitrust claim, and that the plaintiffs had failed “to adequately allege a relevant market for pathology and dermatopathology services.”
Goldfinch filed a Notice of Appeal on Jan. 10.
State Lawsuits Pending
Meanwhile, both parties are awaiting a decision in a state court lawsuit in which the Goldfinch partners are the defendants, according to the Iowa Capital Dispatch.
IPA filed the suit late in 2022, shortly after learning that the four pathologists planned to leave and start their own practice. It alleged “breach of contract, breach of the common law duty of loyalty, civil conspiracy and tortious interference,” Iowa Capital Dispatchreported at the time, claiming that the pathologists were improperly attempting to lure clients away.
In a related case, Goldfinch pathologists Milless and Halverson have filed a state discrimination lawsuit against their former employer, “alleging they were paid $200,000 to $350,000 annually, which they claim was far less than what some of the less qualified male doctors were paid,” Iowa Capital Dispatch reported. That case goes to trial in August.
This is a plethora of lawsuits involving pathologists and the pathology practices in the communities where they formally practiced. Pathologists and group pathology managers may find useful insights from a study of the legal arguments made by the two parties, as well as the decisions laid down by judges in these court cases.
Study found highest incidences of occupational carcinogenesis among clinical laboratory and histology technicians, followed by pathologists
It has been known for years that formalin (a form of formaldehyde used as a disinfectant and preservative in the handling of tissues samples in anatomy, pathology, and microbiology labs), as well as xylene and toluene, are dangerous to clinical laboratory workers. Nations around the world have taken steps to minimize exposure to these dangerous chemicals. However, a recent study in Iran found that those measures may not have gone far enough to protect histology and clinical laboratory technicians, pathologists, and medical laboratory scientists.
The study conducted by researchers in the Department of Occupational Health Engineering, School of Public Health, at Tehran University of Medical Sciences, showed that levels of exposure to these chemicals is still significantly higher than recommended, resulting in a higher risk for cancer among lab workers in Iran’s hospitals.
“Employing risk assessment techniques as a complementary tool in monitoring programs for respiratory exposure in the different work setting should be considered to protect the staffs against both non-cancerous and cancer-related hazards,” the study authors wrote.
Lessons learned from the Iranian hospital lab study could benefit clinical laboratory workers in US hospitals and help those who work with formaldehyde, toluene, and xylene worldwide to reduce their chances of developing a vascular condition known as Raynaud’s phenomenon (shown above) which can lead to necrosis and gangrene, as well as other dangerous health conditions affecting the lungs, brain, and other systems and organs in the body. (Photo copyright: Wikipedia.)
Study Details
The Iranian study considered the carcinogenic and non-carcinogenic impact of occupational exposure to formaldehyde in the pathology laboratories of four Tehran hospitals. The researchers “used a quantitative risk assessment method proposed by the United States Environmental Protection Agency (EPA), along with its provided database known as the Integrated Risk Information System (IRIS). Respiratory symptoms were assessed using the American Thoracic Society (ATS) questionnaire,” the study authors wrote in NatureScientific Reports.
The scientists found that “91.23% of exposure levels in occupational groups exceed the NIOSH [National Institute for Occupational Safety and Health] standard of 0.016 ppm.” They determined that “41.03% of all the studied subjects were in the definite carcinogenic risk range (LCR > 10−4), 23.08% were in the possible carcinogenic risk range (10−5 < LCR < 10−4), and 35.90% were in the negligible risk range (LCR < 10−6),” they wrote.
“The highest index of occupational carcinogenesis was observed in the group of lab technicians with a risk number of 3.7 × 10-4, followed by pathologists with a risk number of 1.7 × 10-4,” the scientists wrote. “Furthermore, 23.08% of the studied subjects were within the permitted health risk range (HQ < 1.0), while 76.92% were within the unhealthy risk range (HQ > 1.0),” they added.
“Formaldehyde exhibits high solubility in water and is rapidly absorbed by the nasal cavity, sinuses, throat, and mucous membrane of the upper respiratory tract upon exposure,” the study authors wrote. “Consequently, due to the elevated potential for both carcinogenic and non-carcinogenic formaldehyde exposure among pathology staff—particularly laboratory technicians—the implementation of management measures … becomes imperative to lower the exposure levels of all employees below permissible limits.”
Those management measures include:
“Strict guideline adherence and safe work protocols,
“Increasing staff numbers to decrease exposure duration,
“Adoption of engineering solutions such as localized ventilation systems, and
“Use of respiratory protective equipment during sample handling and tissue processing.”
Previous Reports on Exposure Risk to Clinical Lab Workers
The knowledge of the danger behind these chemicals isn’t new.
In 2017, a pathology lab in Auckland, New Zealand, lost its accreditation because formaldehyde levels were so high the lab had to be evacuated nearly every day, The New Zealand Herald reported.
“In epidemiological studies on industrial workers, pathologists and anatomists, the relationship between exposure to formaldehyde and an increased risk of various types of cancer including nasal cavity, nasopharynx, lung, brain, pancreas, prostate, colon and atopic lymphoma system has been determined,” the Iranian scientists wrote in Nature Scientific Reports.
Call for Stronger Regulations
“The Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC), and the Environmental Protection Agency have expressed serious concern about the carcinogenicity of formaldehyde,” the Iranian scientists noted, adding that “the potential carcinogenic risk to humans has been studied in a number of cohort and case-control studies.”
There is room for more studies looking at the health effects of exposure to these chemicals among lab workers, as well as continued evaluation of the risks and preventative measures that could be taken. Perhaps tightened regulations will make its way to US labs, echoing more stringent ones of the European Union.
“It is imperative to implement control measures across various hospital departments to mitigate occupational formaldehyde exposure levels proactively. These findings can be valuable for policymakers in the health sector, aiding in the elimination or reduction of airborne formaldehyde exposure in work environments,” the Iranian scientists wrote.
Managers of histology and clinical laboratories may find useful advice in hospital laboratory studies like that coming out of Iran. Protecting the health of lab workers worldwide starts with reducing their exposure to deadly chemicals.
Settlement is a reminder to all clinical laboratories that state and federal DOJs and AGs are willing to file actions against genetic testing companies that intentionally mislead the public
California’s Attorney General, in cooperation with the Federal Trade Commission (FTC), announced a recent settlement with CRI Genetics regarding deceptive trade practices. The at-home genetics testing company will have to pay $700,000 in civil penalties and according to the Santa Monica Daily Press, “will be barred from a wide range of deceptive practices to settle charges from the Federal Trade Commission and the California Attorney General that the company deceived users about the accuracy of its DNA reports.”
Santa Monica, Calif.-based CRI Genetics (CRI), which also does business as OmniPGx, offers DNA saliva-swab test kits that are analyzed by a third party laboratory to return customers ancestry data, health information, optimal nutritional guidelines, and potential allergies. The company’s website states a guaranteed 8-week turn around for the kits.
The original complaint against CRI alleged the company used misleading marketing practices by claiming its DNA tests are more accurate and detailed than their competitors, such as Ancestry DNA and 23andMe. CRI also claimed their ancestry data was more than 90% accurate and could determine ancestry dating back 50 generations.
In addition, the company stated its algorithm for matching DNA was patented, which it was not, according to the complaint.
The complaint also alleged the CRI website contained deceitful information and was formatted to appear independent but included inflated reviews and false testimonials.
“CRI Genetics could have found legitimatewaysto market its services. Unfortunately, in its pursuit of growth and profits, the company repeatedly misled consumers. The FTC and my office took notice, we investigated, and we are delivering results today,” said California Attorney General Rob Bonta (above) in a press release. (Photo copyright: State of California Department of Justice.)
Alleged Deceptive Business Practices
According to court documents, CRI manipulated customers into purchasing add-on services and forced consumers to click through a myriad of pop-up pages to lure them into purchasing more products. Customers were informed they would have a chance to review their orders before being charged but were immediately billed. Consumers then had to go through a lengthy and often confusing process to obtain refunds for returned items.
“Based on the facts and violations of law alleged in this Complaint, the FTC has reason to believe that Defendant has violated or is about to violate laws enforced by the Commission because, among other things, Defendant engaged in the unlawful conduct over a period of four years, willfully and knowingly, despite having knowledge of hundreds of consumer complaints and refund requests, as well as inquiries by the Better Business Bureau regarding their deceptive practices and only ceased its unlawful activities after the FTC notified Defendant of its pending investigation,” the court filings state.
“Our settlement not only holds CRI Genetics accountable for its past misconduct, it also aims to ensure that CRI Genetics doesn’t engage in similar misconduct going forward,” said California Attorney General Rob Bonta in the press release. “I want to thank our federal counterparts at the FTC for their continued partnership and commitment to ensuring that all businesses play by the same rules.”
In addition to the $700,000 fine, CRI is obligated to change its practices by:
Ceasing to make misrepresentations about its testing and analysis services.
Not using deceptive tactics to sell its products, represent endorsements, or in billing practices.
Accurately disclosing its website billing practices.
Disclosing any sharing or usage of genetic data for purposes besides the services the consumer purchases.
Refraining from offering the sale of any DNA information testing product or service.
“Today’s action continues the FTC’s crackdown on deceptive reviews, dark patterns, and baseless claims around algorithmic solutions,” said Samuel Levine, Director, Bureau of Consumer Protection at the FTC, in the press release. “We are proud to partner with California on this important matter and will continue to carefully scrutinize claims around biometric information technologies.”
This settlement serves as a reminder to all genetic testing firms and clinical laboratories that state and federal Departments of Justice and state Attorney Generals are willing to file actions against genetic testing organizations that intentionally mislead the public. It is also useful for lab managers to stay aware of the lengths some genetic testing companies will go to deceive consumers and that regulatory agencies are noticing egregious practices.
