Dec 7, 2018 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Experts say medical laboratories must overcome staffing challenges and develop a culture of continual inspection readiness
Clinical laboratories and anatomic pathology groups will be entering 2019 facing not only financial upheaval from Medicare Part B fee cuts and narrowing payer networks, but also an increasingly rigorous and ever-evolving regulatory environment.
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.”
Hess and Anne T. Daley, MS, Quality Officer at ARUP Laboratories in Salt Lake City, UT, will co-present a 90-minute webinar on Dec. 13th titled, “Make Your Lab Assessment Ready in 2019: Know the Most Common Deficiencies in Accreditation and Certification and What to Expect in the Future.”
The program will review the top deficiencies reported by the College of American Pathologists (CAP), the Joint Commission, A2LA, and COLA.
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/).
—Andrea Downing Peck
Related Information:
Make Your Lab Assessment Ready in 2019: Know the Most Common Deficiencies in Accreditation and Certification
CLIA Inspection–What they Mean and How to Avoid Them
‘We Wanted to Be the Best we Could Possibly Be’: CAP ISO 15189-Accredited Labs on the Difference it Makes
Are CLIA Inspections of Clinical Pathology Laboratories Getting Tougher? Why It Pays to Achieve “Inspection Readiness”
Nov 2, 2018 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Patient privacy, ethics of monetizing not-for-profit data, and questions surrounding industry conflicts appear after the public announcement of an arrangement to grant exclusive access to academic pathology slides and samples
Clinical laboratories and anatomic pathology groups already serve as gatekeepers for a range of medical data used in patient treatments. Glass slides, paraffin-embedded tissue specimens, pathology reports, and autopsy records hold immense value to researchers. The challenge has been how pathologists (and others) in a not-for-profit academic center could set themselves up to potentially profit from their exclusive access to this archived pathology material.
Now, a recent partnership between Memorial Sloan Kettering Cancer Center (MSK) and Paige.AI (a developer of artificial intelligence for pathology) shows how academic pathology laboratories might accomplish this goal and serve a similar gatekeeper role in research and development using the decades of cases in their archives.
The arrangement, however, is not without controversy.
New York Times, ProPublica Report
Following an investigative report from the New York Times (NYT) and ProPublica, pathologists and board members at MSK are under fire from doctors and scientists there who have concerns surrounding ethics, exclusivity, and profiting from data generated by physicians and but owned by MSK.
“Hospital pathologists have strongly objected to the Paige.AI deal, saying it is unfair that the founders received equity stakes in a company that relies on the pathologists’ expertise and work amassed over 60 years. They also questioned the use of patients’ data—even if it is anonymous—without their knowledge in a profit-driven venture,” the NYT article states.
Prominent members of MSK are facing scrutiny from the media and peers—with some relinquishing stakes in Paige.AI—as part of the backlash of the report. This is an example of the perils and PR concerns lab stakeholders might face concerning the safety of data sharing and profits made by medical laboratories and other diagnostics providers using patient data.
Controversy Surrounds Formation of Paige.AI/MSK Partnership
In February 2018, Paige.AI announced closing the deal on a $25-million round of Series A funding, and in gaining exclusive access to 25-million pathology slides and computational pathology intellectual property held by the Department of Pathology at Memorial Sloan Kettering. Coverage by TechCrunch noted that while MSK received an equity stake as part of the licensing agreement, they were not a cash investor.
Creation of the company involved three hospital insiders and three additional board members with the hospital itself established as part owner, according to STAT.
Unnamed officials told the NYT that board members at MSK only invested in Paige.AI after earlier efforts to generate outside interest and investors were unsuccessful. NYT’s coverage also notes experts in non-profit law and corporate governance have raised questions as to compliance with federal and state laws that govern nonprofits in light of the Paige.AI deal.
Growing Privacy Fallout and Potential Pitfalls for Medical Labs
The original September 2018 NYT coverage noted that Klimstra intends to divest his ownership stake in Paige.AI. Later coverage by NYT in October, notes that Democrat Representative Debbie Dingell of Michigan submitted a letter questioning details about patient privacy related to Paige.AI’s access to MSK’s academic pathology resources.
Privacy continues to be a focus for both media and regulatory scrutiny as patient data continues to fill electronic health record (EHR) systems as well as research and commercial databases. Dark Daily recently covered how University of Melbourne researchers demonstrated how easily malicious parties might reidentify deidentified data. (See “Researchers Easily Reidentify Deidentified Patient Records with 95% Accuracy; Privacy Protection of Patient Test Records a Concern for Clinical Laboratories”, October 10, 2018.)
According to the NYT, MSK also issued a memo to employees announcing new restrictions on interactions with for-profit companies with a moratorium on board members investing in or holding board positions in startups created within MSK. The nonprofit further noted it is considering barring hospital executives from receiving compensation for their work on outside boards.
However, MSK told the NYT this only applies to new deals and will not affect the exclusive deal between Paige.AI and MSK.
“We have determined,” MSK wrote, “that when profits emerge through the monetization of our research, financial payments to MSK-designated board members should be used for the benefit of the institution.”
There are no current official legal filings regarding actions against the partnership. Despite this, the arrangement—and the subsequent fallout after the public announcement of the arrangement—serve as an example of pitfalls medical laboratories and other medical service centers considering similar arrangements might face in terms of public relations and employee scrutiny.
Risk versus Reward of Monetizing Pathology Data
While the Paige.AI situation is only one of multiple concerns now facing healthcare teams and board members at MSK, the events are an example of risks pathologists take when playing a role in a commercial enterprise outside their own operations or departments.
In doing so, the pathologists investing in and shaping the deal with Paige.AI brought criticism from reputable sources and negative exposure in major media outlets for their enterprise, themselves, and MSK as a whole. The lesson from this episode is that pathologists should tread carefully when entertaining offers to access the patient materials and data archived by their respective anatomic pathology and clinical laboratory organizations.
—Jon Stone
Related Information:
Sloan Kettering’s Cozy Deal with Start-Up Ignites a New Uproar
Paige.AI Nabs $25M, Inks IP Deal with Sloan Kettering to Bring Machine Learning to Cancer Pathology
Sloan Kettering Executive Turns Over Windfall Stake in Biotech Start-Up
Cancer Center’s Board Chairman Faults Top Doctor over ‘Crossed Lines’
Memorial Sloan Kettering, You’ve Betrayed My Trust
LVHN Patient Data Not Shared with For-Profit Company in Sloan Kettering Trials
Researchers Easily Reidentify Deidentified Patient Records with 95% Accuracy; Privacy Protection of Patient Test Records a Concern for Clinical Laboratories
Oct 24, 2018 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Pathology, Laboratory Sales and Marketing, Laboratory Testing, Management & Operations
Though patients get a big discount when paying for drugs, copay accumulators prohibit discounts from applying to plan deductibles, extending time it takes for enrollees to reach full plan coverage
There’s a new insurance/payer industry tactic in town and Dark Daily thinks clinical laboratories and anatomic pathology groups should know about it. It’s called a “copay accumulator” and it was designed by payers in response to pharmaceutical company copay assistance cards and discount coupons.
How do Copay Accumulators Work?
Many consumers use manufacturer copay assistance programs, copay cards, and coupons to afford expensive brand-name medications. As payers attempt to make consumers pay a higher portion of drug costs, pharmaceutical companies have responded by offering financial aid to patients in the form of copay assistance cards and coupons. These discounts insulate patients from having to pay the full deductible required by their health insurance plans for medicines prescribed by their doctors.
However, payers say these deductibles were designed to motivate patients to monitor the price of prescribed drugs and discourage the overutilization of costly medicines. A primary goal of price transparency and precision medicine.
The upside to payers is, with a copay accumulator in place, the amount of those manufacturer discounts does not count toward the patient’s insurance deductible. And the longer it takes for patients to reach their deductibles, the longer the insurer gets to collect copays, which adds to the controversy of copay accumulators.
Also, prohibiting drug manufacturer discounts from counting toward a patient’s insurance deductible prolongs the time patients have to wait before full coverage begins. Thus, more upfront costs are shifted to consumers.
“Copay accumulator programs are nothing more than insurance scheme[s] that leave patients financially exposed while benefiting payers’ bottom lines,” Stephen J. Ubl, President and Chief Executive Officer, Pharmaceutical Research and Manufacturers of America (PhRMA), told the LA Times.
Others, however, claim manufacturer discounts are simply marketing schemes used by pharmaceutical companies to keep drug costs high.
“The true issue remains that drug pricing continues to skyrocket, with no clear explanation on how those prices are set,” Cathryn Donaldson, Director of Communications, America’s Health Insurance Plans (AHIP), told the LA Times. “Copay coupon programs hide the true impact of rising prescription drug costs.” (Photo copyright: AHIP.)
Patients Stuck in the Middle
Physicians and patient advisory groups worry that shifting more drug costs to patients may affect therapy adherence and cause confusion for consumers.
“Accumulators are seen as a way to keep manufacturers in line and force them to negotiate better deals,” Randy Vogenberg, PhD, Principal, Institute for Integrated Healthcare (IIH), told Managed Care.
“But the Achilles heel for the pharmacy benefits manager is that you’re hurting the patient, who is stuck in the middle,” continued Vogenberg. “Patients may end up not taking or getting a drug, which is not good for anyone. And it’s not really affecting pricing because patients are still hurting. Unfortunately, it makes the third-party payer look like a crook.”
Managed Care notes that, according to a recent survey of 170 employers conducted by the National Business Group on Health (NBGH), 29% of employers plan on using copay accumulators in 2019. That’s up from the 17% of employers who are currently using them.
“They are not universal yet,” Steve Wojcik, Vice President of Public Policy at the NBGH, told Managed Care. “But they will probably continue to be one tool that employers use to keep costs down.”
Drug Costs Down, Cost to Patients Up
The struggles between payers and big pharma could be heating up. Studies show utilization of copay accumulators may be negatively impacting drug company revenue. Research conducted by Sector and Sovereign (SSR) found that retail drug prices in the United States fell 5.6% during the first quarter of this year. During the same period last year, prices fell just 1.7%. SSR’s report states that most of the decline in prices is due to copay accumulators.
“Unless manufacturers adapt their copay support programs fairly drastically, net price declines may worsen in 2019,” SSR analyst Richard Evans told Reuters.
Clinical laboratories might not directly feel the effects of copay accumulators. Nevertheless, anything that impacts patients’ ability to pay, especially those on high-deductible health plans, should be on the radar of smart lab managers and stakeholders.
—JP Schlingman
Related Information:
Copay Accumulators: Costly Consequences of a New Cost-Shifting Pharmacy Benefit
Backlash Against Copay Accumulators
Copay Accumulators: The Deductible Double-Dip
They’re Called ‘Copay Accumulators,’ and They’re a Way Insurers Make You Pay More for Meds
Insurance Tactic Drags Down U.S. Drug Prices in 2nd Quarter
Oct 12, 2018 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Diagnostic medical laboratories may sequence DNA genetic tests correctly, but there are issues with how companies analyze the information
In 2017, some 12 million people paid to spit in a tube and have their genetic data analyzed, according to Technology Review. Many companies offer this type of DNA testing, and each of them works with one or more clinical laboratories to get the actual sequencing performed. For example, Ancestry.com, one of the largest direct-to-consumer genetic data testing companies, works with both Quest Diagnostics and Illumina.
In the case of Quest Diagnostics, the clinical laboratory company does the actual sequencing for Ancestry. But the analysis of the genetic data for an individual and its interpretation is performed by Ancestry’s team.
There are critics of the booming direct-to-consumer genetic testing business, but it’s not due to the quality of the sequencing. Rather, critics cite other issues, such as:
- Privacy concerns;
- How the physical samples are stored and used;
- Who owns the data; and,
- That this branch of genetics is an area of emerging study and not clearly understood.
What Does All That Genetic Data Mean?
The consumer DNA testing market was worth $359 million dollars in 2017 and is projected to grow to $928 million by 2023, according to a report from Research and Markets. Those numbers represent a lot of spit, and an enormous amount of personal health information. As of now, some one in every 25 adults in the US has access to their genetic data. But, what does all that data mean?
The answer depends, in large part, on who you ask. Many reporters, scientists, and others have taken multiple DNA tests from different companies and received entirely different results. In some cases, the sequencing from one sample submitted to different companies for analysis have rendered dramatically different results.
“There is a wild-west aspect to all of this,” Erin Murphy, a New York University law professor and genetics specialist who focuses on privacy implications, told McClatchy. “It just takes one person in a family to reveal the genetic information of everyone in the family,” she notes. (Photo copyright: New York University.)
It’s All About the Database
Although some people purchase kits from multiple companies, the majority of people take just one test. Each person who buys genetic analysis from Ancestry, for example, consents to having his/her data become part of Ancestry’s enormous database, which is used to perform the analyses that people pay for. There are some interesting implications to how these databases are built.
First, they are primarily made up of paying customers, which means that the vast majority of genetic datasets in Ancestry’s database come from people who have enough disposable income to purchase the kit and analysis. It may not seem like an important detail, but it shows that the comparison population is not the same as the general population.
Second, because the analyses compare the sample DNA to DNA already in the database, it matters how many people from any given area have taken the test and are in the database. An article in Gizmodo describes one family’s experience with DNA testing and some of the pitfalls. The author quotes a representative from the company 23andMe as saying, “Different companies have different reference data sets and different algorithms, hence the variance in results. Middle Eastern reference populations [for example] are not as well represented as European, an industry-wide challenge.”
The same is true for any population where not many members have taken the test for a particular company. In an interview with NPR about trying to find information about her ancestry, journalist Alex Wagner described a similar problem, saying, “There are not a lot of Burmese people taking DNA tests … and so, the results that were returned were kind of nebulous.”
Wagner’s mother and grandmother both immigrated to the US from Burma in 1965, and when Wagner began investigating her ancestry, she, both of her parents, and her grandmother, all took tests from three different direct-to-consumer DNA testing companies. To Wagner’s surprise, her mother and grandmother both had results that showed they were Mongolian, but none of the results indicated Burmese heritage. In the interview she says that one of the biggest things she learned through doing all these tests was that “a lot of these DNA test companies [are] commercial enterprises. So, they basically purchase or acquire DNA samples on market-demand.”
As it turns out, there aren’t many Burmese people taking DNA tests, so there’s not much reason for the testing companies to pursue having a robust Burmese or even Southeast Asian database of DNA.
Who Owns Your Genetic Data?
As is often the case when it comes to technological advances, existing law hasn’t quite caught up with the market for ancestry DNA testing. There are some important unanswered questions, such as who owns the data that results from a DNA analysis?
An investigation conducted by the news organization McClatchy found that Ancestry does allow customers to request their DNA information be deleted from the company’s database, and that they can request their physical sample be destroyed as well. The author writes, “But it is a two-step process, and customers must read deep into the company’s privacy statement to learn how to do it. Requests for DNA data elimination can be made online, but the company asks customers to call its support center to request destruction of their biological sample.”
Another concern is hacking or theft. Ancestry and similar companies take steps to protect customers’ information, such as using barcodes rather than names and encryption when samples are sent to labs. Nevertheless, there was an incident in 2017 in which hackers infiltrated a website owned by Ancestry called RootsWeb. “The RootsWeb situation was certainly unfortunate,” Eric Heath, Ancestry’s Chief Privacy Officer, told McClatchy. He added that RootsWeb was a “completely separate system” from the Ancestry database that includes DNA information.
What We Don’t Know
The biggest pitfall for consumers may be that geneticists don’t know very much about DNA analysis. Adam Rutherford, PhD, is a British geneticist who interviewed for the Gizmodo story. He said that the real problem with companies like Ancestry is that people have a basic, fundamental misunderstanding of what can be learned from a DNA test.
“They’re not telling you where your DNA comes from in the past. They’re telling you where on Earth your DNA is from today,” Rutherford told Gizmodo.
Science evolves, of course, and genetic testing has much evolving to do. The author of the Gizmodo piece writes, “It’s not that the science is bad. It’s that it’s inherently imperfect.” There aren’t any best-practices for analyzing DNA data yet, and companies like Ancestry aren’t doing much to make sure their customers understand that fact.
Nevertheless, issues surrounding genetic testing, the resulting data, and its storage, interpretation, and protection, continue to impact clinical laboratories and anatomic pathology groups.
—Dava Stewart
Related Information:
2017 Was the Year Consumer DNA Testing Blew Up
Quest Diagnostics and Ancestry DNA Collaborate to Expand Consumer DNA Testing
Illumina, Secret Giant of DNA Sequencing, Is Bringing Its Tech to the Masses
Global $928 Million Consumer DNA (Genetic) Testing Market 2018-2023 with 23andMe, Ancestry, Color Genomics and Gene by Gene Dominating
How DNA Testing Botched My Family’s Heritage, and Probably Yours, Too
A Journalist Seeks Out Her Roots but Finds Few Answers in the Soil
Ancestry Wants Your Spit, Your DNA and Your Trust. Should You Give Them All Three?
Oct 10, 2018 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Protecting patient privacy is of critical importance, and yet researchers reidentified data using only a few additional data points, casting doubt on the effectiveness of existing federally required data security methods and sharing protocols
Clinical laboratories and anatomic pathologists know the data generated by their diagnostics and testing services constitute most of a patient’s personal health record (PHR). They also know federal law requires them to secure their patients’ protected health information (PHI) and any threat to the security of that data endangers medical laboratories and healthcare practices as well.
Therefore, recent coverage in The Guardian which reported on how easily so-called “deidentified data” can be reidentified with just a few additional data points should be of particular interest to clinical laboratory and health network managers and stakeholders.
Risky Balance Between Data Sharing and Privacy
In December 2017, University of Melbourne (UM) researchers, Chris Culnane, PhD, Benjamin Rubinstein, and Vanessa Teague, PhD, published a report with the Cornell University Library detailing how they reidentified data listed in an open dataset of Australian medical billing records.
“We found that patients can be re-identified, without decryption, through a process of linking the unencrypted parts of the record with known information about the individual such as medical procedures and year of birth,” Culnane stated in a UM news release. “This shows the surprising ease with which de-identification can fail, highlighting the risky balance between data sharing and privacy.”
In a similar study published in Scientific Reports, Yves-Alexandre de Montjoye, PhD, a computation private researcher, used location data on 1.5 million people from a mobile phone dataset collected over 15 months to identify 95% of the people in an anonymized dataset using four unique data points. With just two unique data points, he could identify 50% of the people in the dataset.
“Location data is a fingerprint. It’s a piece of information that’s likely to exist across a broad range of data sets and could potentially be used as a global identifier,” Montjoye told The Guardian.
The problem is exacerbated by the fact that everything we do online these days generates data—much of it open to the public. “If you want to be a functioning member of society, you have no ability to restrict the amount of data that’s being vacuumed out of you to a meaningful level,” Chris Vickery, a security researcher and Director of Cyber Risk Research at UpGuard, told The Guardian.
This privacy vulnerability isn’t restricted to just users of the Internet and social media. In 2013, Latanya Sweeney, PhD, Professor and Director at Harvard’s Data Privacy Lab, performed similar analysis on approximately 579 participants in the Personal Genome Project who provided their zip code, date of birth, and gender to be included in the dataset. Of those analyzed, she named 42% of the individuals. Personal Genome Project later confirmed 97% of her submitted names according to Forbes.
In testimony before the Privacy and Integrity Advisory Committee of the Department of Homeland Security (DHS), Latanya Sweeney, PhD (above), Professor and Director at Harvard’s Data Privacy Lab stated, “One problem is that people don’t understand what makes data unique or identifiable. For example, in 1997 I was able to show how medical information that had all explicit identifiers, such as name, address and Social Security number removed could be reidentified using publicly available population registers (e.g., a voter list). In this particular example, I was able to show how the medical record of William Weld, the Governor of Massachusetts of the time, could be reidentified using only his date of birth, gender, and ZIP. In fact, 87% of the population of the United States is uniquely identified by date of birth (e.g., month, day, and year), gender, and their 5-digit ZIP codes. The point is that data that may look anonymous is not necessarily anonymous. Scientific assessment is needed.” (Photo copyright: US Department of Health and Human Services.)
These studies reveal that—regardless of attempts to create security standards—such as the Privacy Rule in the Health Insurance Portability and Accountability Act of 1996 (HIPAA)—the sheer amount of available data on the Internet makes it relatively easy to reidentify data that has been deidentified.
The Future of Privacy in Big Data
“Open publication of deidentified records like health, census, tax or Centrelink data is bound to fail, as it is trying to achieve two inconsistent aims: the protection of individual privacy and publication of detailed individual records,” Dr. Teague noted in the UM news release. “We need a much more controlled release in a secure research environment, as well as the ability to provide patients greater control and visibility over their data.”
While studies are mounting to show how vulnerable deidentified information might be, there’s little in the way of movement to fix the issue. Nevertheless, clinical laboratories should consider carefully any decision to sell anonymized (AKA, blinded) patient data for data mining purposes. The data may still contain enough identifying information to be used inappropriately. (See Dark Daily, “Coverage of Alexion Investigation Highlights the Risk to Clinical Laboratories That Sell Blinded Medical Data,” June 21, 2017.)
Should regulators and governments address the issue, clinical laboratories and healthcare providers could find more stringent regulations on the sharing of data—both identified and deidentified—and increased liability and responsibility regarding its governance and safekeeping.
Until then, any healthcare professional or researcher should consider the implications of deidentification—both to patients and businesses—should people use the data shared in unexpected and potentially malicious ways.
—Jon Stone
Related Information:
‘Data Is a Fingerprint’: Why You Aren’t as Anonymous as You Think Online
Research Reveals De-Identified Patient Data Can Be Re-Identified
Health Data in an Open World
The Simple Process of Re-Identifying Patients in Public Health Records
Harvard Professor Re-Identifies Anonymous Volunteers in DNA Study
How Someone Can Re-Identify Your Medical Records
Trading in Medical Data: Is this a Headache or An Opportunity for Pathologists and Clinical Laboratories
Coverage of Alexion Investigation Highlights the Risk to Clinical Laboratories That Sell Blinded Medical Data
Sep 24, 2018 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations, News From Dark Daily
It’s the next wave in the long-running trend of hospital laboratory consolidation, as the need to trim costs and support thriving medical laboratory outreach programs continues
There’s an important new development in the hospital/health system sector of the clinical laboratory industry that continues the longstanding trend of consolidating multi-site lab operations. It is to rationalize and standardize medical laboratory operations across all lab sites within the health system. Effectively, this standardization trend represents the next cycle of clinical laboratory consolidation.
One recent example of this trend can be found at Atrium Health, the hospital health network based in Charlotte, N.C. (formerly known as Carolinas HealthCare System until earlier this year). Becker’s Hospital Review states that Atrium Health is the “seventh largest nonprofit system in the country based on number of acute-care hospitals (35).”
Creating Standardized Medical Laboratory Testing Services at Multiple Sites
Over the past four years, the clinical laboratory team at Atrium Health has worked to design, build, and operate a new, state-of-the-art core laboratory. At the same time, there were sequential projects to integrate the lab testing services and operations of nine other medical lab sites within the health system to better align the test menu, lab instruments, and workflow at these sites with the activities of the core laboratory.
According to Modena Henderson, MHA, the Vice President of Laboratory Services at Atrium Health, in an interview with Dark Daily, there were multiple primary goals in this project to rationalize and standardize lab testing at all the participating lab sites. They include:
- Standardizing lab test methodologies, reference ranges, and test menu;
- Standardizing analyzers and test platforms across all labs;
- Using Lean, Six Sigma, and other process improvement methods to streamline workflow and reduce test turnaround time;
- Improve productivity of lab staff;
- Increase quality while reducing or eliminating unproductive activities;
- Using real-time analytics middleware to keep lab management informed on a daily basis, and,
- Collaborating with emergency departments, wards, and outreach physicians to deliver more value with clinical lab testing services.
Using the ‘Three Ps of Project Management’ Approach in Health System Labs
The centerpiece of this program of lab rationalization and consolidation was the design and build-out for a new core clinical laboratory facility. Henderson said her team followed the principals of the “Three Ps of Project Management”—People, Process, Performance—to model the new lab facility, then guide how it was constructed and brought into daily clinical service.
“The Atrium Health laboratory regionalization project is an example of the next step that many innovative hospital laboratories are taking,” stated Robert L. Michel, Editor-in-Chief of The Dark Report. “Every lab has the same double challenge. First is financial. Hospital lab budgets are shrinking as growth in inpatient admissions slows. Outreach revenues are declining as Medicare and private payers slash lab test prices.
“Second, labs must come up with the capital needed to acquire and deploy the expensive and sophisticated new genetic and molecular tests that physicians and patients want,” he continued. “Hospital and health network labs must offer these new tests to keep their parent organizations at the cutting edge of clinical care.
Clinical Labs See Value in Standardizing Test Methodologies, Menus
“Thus, it is logical for the clinical labs of health networks to begin the process of rationalizing and standardizing their test menus, methodologies, and analyzers at every site within the system that performs medical lab testing,” emphasized Michel. “This is a development that we have watched gather momentum.”
Keynote Speaker Robert L. Michel, Editor-in-Chief of The Dark Report and Dark Daily will discuss how clinical laboratories of hospitals and health networks are rationalizing and standardizing their medical laboratory testing services to achieve the goals of managing lab costs, boosting quality, and increasing lab outreach revenue. The 12th annual Lab Quality Confab takes place on Oct. 9-10, 2018, at the Hyatt Regency Atlanta. (Photo copyright: The Dark Report.)
Michel offered two examples of sizable programs to rationalize and standardize clinical lab tests and services across a large health system. One is in Michigan, at Ascension Health. The other is in the Canadian Province of Québec. Both are large and ambitious undertakings, both in the number of lab sites involved and the large geography served by these clinical laboratories.
Consolidation Project in Québec involves 123 Clinical Lab Facilities
Québec’s provincial health system wants to consolidate 123 clinical laboratories in the province into 11 groups (clusters) of labs. Each lab group, or cluster, will have a core lab and rapid response labs. Test menus and methodologies will be standardized throughout the province. In an interview with The Dark Report, Ralph Dadoun, PhD, Project Director for Optilab Québec, plans to accomplish the consolidation without adding costs.
In Michigan, Ascension’s clinical lab leadership is working to integrate and standardize the labs that are operated by seven system organizations. This includes 14 hospitals and 18 existing laboratories located throughout the entire State of Michigan. In an interview with The Dark Report, Carlton Burgess, MSM, Vice President of Laboratory Services at Ascension Health’s St. John Providence Clinical Pathology Laboratory in Grosse Pointe Woods, Mich., stated that the goal is to have all the labs in the state work together in a seamless, integrated fashion.
Regional Lab Integration at North Carolina’s Biggest Health System
“To achieve this, the labs will be linked in four regions—a process we describe as regional integration,” explained Burgess. “Each region has a core lab and rapid response labs and each region will be responsible for building lab volume through increased outreach testing. In addition to changing how labs serve each region, our statewide standardization project has three objectives:
- “Repatriate existing send-out lab testing back into Michigan;
- “Establish standard test menus for each facility; and,
- “Renew each lab’s focus on growing lab outreach business.
“Every lab administrator and pathologist working in hospital and health network laboratories should be tracking this new trend of regionalization and standardization of hospital labs,” observed Michel. “That’s because labs already moving down this path are setting new standards for the entire clinical laboratory industry. This goes beyond cost and productivity, because these labs are putting the systems in place that will allow them to deliver more value to physicians and thus be paid more for that value by private health insurers.”
Innovative Lab Leaders to Speak at Lab Quality Confab in Atlanta
Lab leaders from Ascension Health will be keynote speakers at the upcoming 12th Annual Lab Quality Confab that takes place on October 9-10, 2018, at the Hyatt Hotel in Atlanta. They will also conduct multiple learning sessions to share their successes and lessons learned in building a new core laboratory and using that as a foundation to rationalize and standardize test methods, reference ranges, menus, lab automation, and analyzers at every clinical lab facility in the Ascension Health system. Sessions by Ascension Health lab leaders include:
- Leveraging Lean to become a Best-in-Class Lab Performer: How We Built and Automated a New Core Lab while Integrating Lab Operations and Helping Staff Embrace a New Culture; Modena Henderson, Vice President, Laboratory Services, and, Steven Harris, Assistant Vice President, Atrium Health.
- Achieving Standardized, High-Performance Lab Testing Services at Multiple Hospitals Using Lean Methods and Effective Engagement with Lab Staff and Nurses; Gary Catarella, MBA, MT(ASCP), Assistant Vice President, Hospital Operations, Atrium Health.
- Lessons We’ve Learned in Our Step-by-Step Journey to Transform Lab Operations and Integrate Testing across All Sites: Engaging Staff, Sustaining Change, Working with Vendors and Consultants—Interactive Roundtable Discussion; Modena Henderson, Vice President, Laboratory Services; and, Steven Harris, Assistant Vice President, Atrium Health.
Using Lean, Six, Sigma, ISO 15189 in Clinical Laboratory Operations
Lab Quality Confab this year features 60 speakers and 40 presentations from lab administrators, pathologists, and other lab managers on their successes and innovations using Lean, Six Sigma, ISO 15189, and other process management methods. You can view the full agenda here (or copy and paste this URL into your web browser: https://www.labqualityconfab.com/agenda).
This year’s Lab Quality Confab is on track to be the largest in its 12-year history. Limited spaces are still available. To ensure your place, register today at: https://www.labqualityconfab.com/register (or copy and paste this URL into your web browser: https://www.labqualityconfab.com/register).
Also, you can bring your lab team and make this Lab Quality Confab a group learning opportunity. When you bring four or more from your organization, each can register for $695 for this two-day learning event. One benefit you’ll gain from bringing your team is that it will give them the knowledge, the tools, and the confidence to help your lab reduce costs without compromising quality, while supporting sustained revenue growth from your hospital lab’s successful outreach program.
—Michael McBride
Related Information:
Full Agenda and Other Details for 12th Annual Lab Quality Confab
To Register for 12th Annual Lab Quality Confab
10 Things to Know about Atrium Health, Formerly Carolinas HealthCare System
Québec’s Laboratory Consolidation Plan Aims to Save $13.5 Million: Optilab Québec to move 123 labs into 11 lab groups
Michigan’s Ascension to Standardize Labs Throughout the State: Goals Are Common Test Methods, Menus, Practices
