Jan 3, 2018 | Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
University of Turin study in Italy shows under-vacuum sealing systems reduce exposure to formaldehyde by 75% among nurses handling tissue biopsy specimens during surgery
Histology technicians and anatomic pathology (AP) laboratories regularly handle dangerous chemicals such as formaldehyde. They understand the risks exposure brings and take precautions to minimize those risks. However, in operating suites worldwide, nurses assisting surgeons also are being exposed to this nasty chemical.
Nurses must place biopsies and other tissues into buckets of formaldehyde to preserve the tissue between the operating room (OR) and histology laboratory. Formaldehyde, along with toluene, and xylene, is used to process and preserve biopsy tissue, displace water, and to create glass slides. It is an important substance that has long been used to maintain the viability of tissue specimens. Thus, exposure to formaldehyde among nurses is well-documented.
According to a National Academy of Sciences report, formalin, a tissue preservative that is a form of formaldehyde, has been linked to:
· Myeloid leukemia;
· Nasopharyngeal cancer; and,
· Sinonasal cancer.
However, as Dark Daily previously reported, “One alternative to storing specimens in buckets with formalin is to vacuum-seal specimens … [so] that both the quality management of the patient specimen and worker safety for handling the specimens are greatly improved.” (See Dark Daily, “Anatomic Pathology Labs Adopt New Ways to Package, Transport, and Store Specimens to Reduce Formalin and Improve Staff Safety in Operating Theaters and Histology Laboratories,” October 13, 2014.)
Now, motivated by increasing formaldehyde regulations in Europe, as well as the need to increase awareness of exposure risks, the University of Turin (Unito), and other hospitals in Italy’s Piedmont region, conducted a cross-sectional study of 94 female nurses who were being potentially exposed to formaldehyde.
Researchers Aim for “Formalin-Free” Hospitals
The Unito study showed that nurses using an under-vacuum sealing (UVS) system in ORs are exposed to levels of formaldehyde 75% lower than those who did not use the system. This study differs from other similar tests because the level of exposure is not just potential, due to environmental contamination, but confirmed with analytic data from specific urine analyses.
The researchers divided the nurses into two groups:
· One group immersed samples in containers of formaldehyde following standard procedures;
· The other group worked in operating rooms equipped with a UVS system.
The researchers described a UVS system that called for the tissue removed during surgery to be sealed in a medical grade vacuum bag and refrigerated at four degrees centigrade before being transferred to the lab for fixation.
One example of a UVS system is TissueSAFE plus, developed by Milestone Medical, located in Bergamo, Italy, and Kalamazoo, Mich. According to the company’s website, the system, “Eliminates formalin in the operating theatre and allows a controlled formalin-free transfer of biospecimens to the laboratory.”
The image above is from a research paper by Richard J. Zarbo, MD, Pathology and Laboratory Medicine, Henry Ford Health System. It describes “five validation trials of new vacuum sealing technologies that change the approach to the preanalytic ‘front end’ of specimen transport, handling, and processing, and illustrate their adaptation and integration into existing Lean laboratory operations with reduction in formalin use and personnel exposure to this toxic and potentially carcinogenic fixative.” (Image copyright: Henry Ford Health System/Springer International Publishing.)
Increased Scrutiny Leads to New Pathology Guidelines
In a paper published in Toxicology Research, a journal of The Royal Society of Chemistry, the researchers noted a marked difference related to the adoption of the under-vacuum sealing procedure, as an alternative to formaldehyde for preserving tissues. “Nurses, operating in surgical theatres, are traditionally exposed to formaldehyde because of the common and traditional practice of immersing surgical samples, of a size ranging between two and 30 centimeters, in this preservative liquid (three to five liters at a time) to be later transferred to a [histopathology] lab,” the authors wrote. “We evaluated the conditions favoring the risk of exposure to this toxic reagent and the effect of measures to prevent it.”
Throughout Europe, increased scrutiny has forced medical pathology associations to write new guidelines that accept alternative methods to formaldehyde-based tissue preservation methods.
“In Europe, and in Italy in particular, the level of attention to formaldehyde exposure in the public health hospital system has become very high, forcing pathology associations to rewrite guidelines,” Marco Bellini, General Manager of the Medical Division at Milestone Medical, told Dark Daily. “What makes this study unique from many other similar tests is that the level of exposure has been confirmed with data from specific urine analyses,” he added.
The Italian Society of Pathological Anatomy and Diagnostic Cytology (SIAPEC), a division of the International Academy of Pathology, wrote general guidelines for AP labs that have been accepted and officially published by the Italian Ministry of Health.
The main topic of these guidelines is the preanalytical aspects of specimen collection, transportation, and preservation, where the vacuum method has been indicated as a valid alternative to improve the standardization of these crucial steps in pathology. By moving the starting point for specimen fixation from the OR to the histology labs, parameters can be controlled and documented, with the main advantage of reducing formaldehyde exposure by operators at the collection point.
These guidelines will be presented at the European Society of Pathology (ESP) with the intent to extending them throughout Europe.
Toluene’s and Xylene’s Effects Studied
Formaldehyde is not the only potentially harmful substance in the clinical laboratory. As previously noted, common solvents toluene and xylene also are potentially hazardous.
In fact, a study of pathologists, lab technicians, and scientists who work with toluene and xylene published in the Journal of Rheumatology found that the chance of acquiring Raynaud Syndrome (a vascular condition) doubled for those workers. (See Dark Daily, “Health of Pathology Laboratory Technicians at Risk from Common Solvents like Xylene and Toluene,” July 5, 2011.)
Medical laboratory leaders are reminded to initiate processes that ensure safe specimen handling, transport, and processing, as well as workflow changes that eliminate chemical odors in the lab. Studies, such as those cited above, may provide information necessary to affect change.
—Donna Marie Pocius
Related Information:
Formaldehyde Fact Sheet
Towards a Formalin-Free Hospital: Levels of 15-F2t-isoprostane and malondialdehyde to Monitor Exposure to Formaldehyde in Nurses from Operating Theatres
Histologic Validation of Vacuum Sealed, Formalin-Free Tissue Preservation, and Transport System
Notes Regarding the Use of Formalin, Reclassified as “Carcinogenic”
Formaldehyde Substitute Fixatives: Analysis of Macroscopy, Morpholologic Analysis, and Immunohistochemical Analysis
Anatomic Pathology Labs Adopt New Ways to Package, Transport, and Store Specimens to Reduce Formalin and Improve Staff Safety in Operating Theaters and Histology Laboratories
Health of Pathology and Laboratory Technicians at Risk from Common Solvents Like Xylene and Toluene
National Academy of Sciences Confirms that Formaldehyde Can Cause Cancer in a Finding that has Implications for Anatomic Pathology and Histology Laboratories
Sep 20, 2017 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement, Management & Operations, News From Dark Daily
To offset the loss of revenue from the price cuts to Medicare Part B clinical laboratory tests, labs will need to aggressively—but wisely—slash costs to balance their budgets
Any day now, Medicare officials will announce the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) for 2018. Both the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) have issued reports indicating that these fee cuts will total $400 million just during 2018, which Dark Daily reported on in July.
Many experienced industry executives expect this to be the single most financially disruptive event to hit the clinical laboratory profession in more than 20 years. This will not only have a substantial negative financial impact on all labs—large and small—but two sectors of the clinical lab industry are considered to be so financially vulnerable they could cease to exist.
At Greatest Risk of Financial Failure are Community Laboratories
The first sector is comprised of smaller community lab companies that operate in towns and rural areas. These labs are at the greatest risk because they are the primary providers of lab testing services to the nursing homes and skilled nursing facilities in their neighborhoods. And because they have a high proportion of Medicare Part B revenue.
Thus, the expected Medicare price cuts to the high-volume automated lab tests—such as chemistry panels and CBCs (complete blood count) that are the bread-and-butter tests for these labs—will swiftly move them from minimal profit margins to substantial losses. Since these labs have a cost-per-test that is significantly higher than the nation’s largest public lab companies, they will be unable to financially survive the 2018 Medicare fee cuts.
The second sector at risk is comprised of rural hospitals and modest-sized community hospitals. What officials at CMS and their consulting companies overlooked when they created the PAMA (Protecting Access to Medicare Act) private payer market price reporting rule is that these hospitals provide lab testing services to nursing homes and office-based physicians in their service areas.
Because of the low volumes of testing in these hospital labs, they also have a larger average cost-per-test than the big public labs. Thus, the 2018 cuts to Medicare Part B lab test prices will erode or erase any extra margin from this testing that now accrues to these hospitals.
Rural and Small Community Hospitals Rely on Lab Outreach Revenue
The financial disruption these Medicare lab test price cuts will cause to rural and community hospitals is a real thing. These hospitals rely on outreach lab test revenues to subsidize many other clinical services within the hospital. One rural hospital CEO confirmed the importance of lab outreach revenue to her organization. Michelle McEwen, FACHE, CEO of Speare Memorial Hospital in Plymouth, N.H., spoke to The Dark Report in 2012 about the financial disruption that was happening when a major health insurer excluded her hospital’s laboratory from its network.
Speare Memorial is a 25-bed critical access hospital in the central part of the state between the lakes region and the White Mountain National Forest. McEwen was blunt in her assessment of the importance of clinical laboratory outreach revenues to her hospital. “The funds generated by performing these [outreach] lab tests are used to support the cost of providing laboratory services to all patients 24/7, including stat labs for emergency patients and inpatients,” McEwen explained. “These funds also help support other services in the hospital where losses are typically incurred, such as the emergency room and obstetric programs.” (See “Critical Access Hospitals Losing Lab Test Work,” The Dark Report, April 2, 2012.)
For the second consecutive year, Lab Quality Confab (LQC) is offering an extended session on clinical laboratory accreditation and certification in New Orleans on October 24-25. CMS has indicated it will participate in this year’s session. It was an historic first for the clinical laboratory industry when last year’s Lab Quality Confab convened a panel that included experts in CLIA laboratory inspection and compliance from the four deeming organizations. From left to right: Moderator Nora L. Hess, MBA, MT(ASCP), PMP, Senior Consultant, Operations Management, Chi Solutions, Inc., Ann Arbor, Mich.; Kathy Nucifora, MPH, MT(ASCP), Director of Accreditation, COLA, Columbia, Md.; Stacy Olea, MBA, MT(ASCP), FACHE, Executive Director of Laboratory Accreditation Program, The Joint Commission, Oakbrook Terrace, Ill.; Randall Querry, Accreditation Manager, Clinical, American Association for Laboratory Accreditation (A2LA), Frederick, Md.; Robert L. Michel, Editor-in-Chief, The Dark Report, Spicewood, Texas; and Denise Driscoll, MS, MT(ASCP)SBB, Senior Director, Laboratory Accreditation and Regulatory Affairs, College of American Pathologists, Northfield, IL. (Photo by Linda Reineke of Riverview Photography. Copyright: The Dark Report.)
All Medical Laboratories Will Suffer Financial Pain from Medicare Price Cuts
But it is not just community lab companies and rural hospitals that are at risk of financial failure as the Medicare Part B cuts are implemented by CMS on Jan. 1, 2018. Any clinical laboratory serving Medicare patients will experience a meaningful drop in revenue. Many larger hospital and health system laboratories are recasting their financial projections for 2018 to identify how big a drop in revenue they will experience and what cost-cutting strategies will be needed to at least break even on their lab outreach business.
This explains why the first big trend of 2018 will be substantial revenue cuts from the Medicare program. It also explains why the second big trend of 2018 will be smart cost-cutting as labs attempt to balance their books and lower spending proportional to the reduced income they project.
Labs Have a Decade of Successful Cost-Cutting, More Cuts are Difficult
Aggressive cost-cutting, however, puts the nation’s medical laboratories at risk for a different reason. For the past decade, most well-run labs have already harvested the low-hanging fruit from obvious sources of cost reduction. They installed latest-generation automation. They re-engineered workflows using the techniques of Lean, Six Sigma, and process improvement.
During these same years, most medical laboratories also reduced technical staff and trimmed management ranks. That has created two new problems:
- First, there are not enough managers in many labs to both handle the daily flow of work while also tackling specific projects to cut costs and boost productivity. Basically, these labs are already at their management limit, with no excess capacity for their lab managers to initiate and implement cost-cutting projects.
- Second, technical staffs are already working at near peak capacity. Increased use of automation at these labs has reduced lab costs because labs were able to do the same volume of testing with fewer staff. However, the reduced staffs that oversee the lab automation are now working at their own peak capacity. Not only are they highly stressed from the daily routine, they also do not have spare time to devote to new projects designed to further cut costs.
Each Year Will Bring Additional Cuts to Medicare Part B Lab Prices
This is why all clinical laboratories in the United States will find it difficult to deal with the Medicare Part lab test fee cuts that will total $400 million during 2018. And what must be remembered is that, in 2019 and beyond, CMS officials will use the PAMA private payer market price reporting rule to make additional fee cuts. Over 10 years, CMS expects these cuts will reduce spending by $5.4 billion from the current spending level.
Taken collectively, all these factors indicate that many medical laboratories in the United States will not survive these Medicare fee cuts. The basic economics of operating a clinical laboratory say that less volume equals a higher average cost per test and higher volume equals a lower average cost per test.
Medical Labs with Highest Costs Most at Risk of Failure from Price Cuts
What this means in the marketplace is that labs with the highest average cost per test make the least profit margin on a fee-for-service payment. The opposite is true for labs with the lowest average cost per test. They will make a greater profit margin on that same fee-for-service payment.
Carry this fundamental economic principle of medical laboratory operations forward as Medicare Part B lab test fee cuts happen in 2018. Labs with the highest average cost per test will be first to go from a modest profit or break-even to a loss. As noted earlier, the clinical lab sectors that have the highest average cost per test are smaller community labs, along with rural and community hospitals. That is why they will be first to go out of business—whether by sale, bankruptcy, or by simply closing their doors.
Learning How to Cut Lab Costs While Protecting Quality
Every pathologist and lab administrator seeking the right strategies to further cut costs in their lab, while protecting quality and enhancing patient services, will want to consider sending a team from their laboratory to the 11th Annual Lab Quality Confab that takes place in New Orleans on October 24-25, 2018.
Anticipating the greater need for shrewd cost-cutting that also protects the quality of the lab’s testing services, this year’s Lab Quality Confab has lined up more than 51 speakers and 39 sessions. Of particular interest are these extended workshops that come with certifications:
- Lean Six Sigma Yellow Belt Training and Certification, led by Maureen Harte, MT(ASCP), LSSBB, Master Black Belt, of HartePro Consulting.
- Mastering Strategic Leadership in Pursuit of Clinical Lab 2.0, led by Karan Arora, Senior Global Marketing Director, Digital Health, Abbott Laboratories.
- Getting More from Lean for Lab Leaders: Henry Ford Production System Lean Gold Certification, led by Richard J. Zarbo, MD, DMD, System Chairman, Pathology and Laboratory Medicine at Henry Ford Hospital.
Sessions will address proven ways to:
- Use real-time analytics to improve workflow in molecular laboratories;
- Introduce automation in microbiology; as well as
- New breakthroughs in core lab automation; and
- Success stories in reducing lab test utilization.
Lab Quality Confab is recognized for its use of lab case studies—taught by the nation’s early adopter lab organizations. Certification classes are available to gain proficiency in the use of Lean methods and Six Sigma tools, such as:
Given the strong interest in smart ways to cut costs, boost productivity, and balance revenue-versus-cost, registrations for this year’s Lab Quality Confab is running at a record pace. The full agenda can be viewed at this link (or copy this URL and paste into your browser: http://www.labqualityconfab.com/agenda).
Of special interest to lab leaders preparing to stay ahead of the financial impact of the Medicare Part B fee cuts, Lab Quality Confab offers deep discounts for four or more attendees from the same lab organization. This allows your lab’s most effective cost-cutters to see, hear, and learn together, so that when they return they can get a flying start helping you align your lab’s costs to the expected declines in revenue that will happen on Jan. 1, 2018.
Reserve your place today and register now http://www.labqualityconfab.com/register.
—Robert L. Michel, Editor-in-Chief
Related Information:
Information, Agenda, and to Register for Lab Quality Confab Taking Place on October 24-25, 2017
In 2017, to Offset Declining Reimbursement and Shrinking Budgets, Savvy Clinical Laboratories Are Using LEAN to Improve Service and Intelligently Cut Costs
Lean-Six Sigma Medical Laboratories Begin to Innovate in Ways That Add Value to Physicians, Payers, and Patients
An Interview with Robert Michel, Editor-in-Chief of The Dark Report
At Lab Quality Confab in New Orleans this Week, Speakers Addressed Major Issues Faced by Medical Laboratories, including the Need for Labs to Deliver More Diagnostic Value to Physicians
Nov 23, 2016 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
With more medical laboratories making progress on improving the operational performance of their labs, and the level of service they provide to their clients, they are finding it essential to have real-time analytics and healthcare relationship management systems
In today’s world of clinical laboratory medicine, the pace of daily operations continues to increase. Everything happens faster as the nation’s leading medical laboratories apply Lean and other process improvement methods to speed up workflow with the goal of shortening lab test turnaround times.
However, those labs making progress on doing more faster and in less time have a challenge: they require information systems and software that can feed essential information to lab managers and staff in real time. It is for this reason that some of the best-selling informatics products in the clinical laboratory industry these days are middleware solutions and healthcare relationship management (HRM) solutions that support real-time analytics and help medical labs improve their client service.
In the past, clinical laboratories and pathology groups often developed in-house solutions to help manage data and generate reports. While data in these systems often drove diagnostic decisions, with the pace of technological change and demands for reduced turnaround times (TATs), these systems often struggled to provide: (more…)
Oct 21, 2016 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
With record attendance of 300 Lean-Six Sigma experts, this week’s conference was a high-energy event that provided medical lab professionals and pathologists with case studies of how to improve lab operations and contribute to better patient care
DATELINE: NEW ORLEANS—Yesterday was the conclusion of the 10th Annual Lab Quality Confab, which showcased innovators in clinical laboratories and anatomic pathology groups. Attendees traveled here from six different countries.
One new trend that emerged from this year’s presentations is that progressive medical labs are beginning to direct their Lean-Six Sigma, and process improvement efforts toward projects designed to add value to client physicians and hospitals. These projects include added-value features of benefit to patients and health insurers.
How Clinical Laboratories Are Succeeding with Lean Projects
This is a shift from prior years. At earlier Lab Quality Confabs, most speakers were describing how their labs were using Lean and quality management methods to improve workflow within their labs, increase the productivity of automation and staff, reduce errors, and cut costs. This was an “inside-the-lab” mindset.
That was not the case here in New Orleans this week. Yes, there were plenty of sessions where workflow redesign, productivity improvement, and cost reduction were discussed. But, at the same time, a significant number of labs doing presentations were describing projects that took the lab team outside of their laboratory to engage with physicians and nurses specifically to help them use clinical laboratory test data in ways that would improve patient care, reduce length-of-stay for hospital patients, and trigger worthwhile reductions of the cost of care. This is an “outside-the-lab” mindset. (more…)
