ASCLS Today Volume 33, Number 3

Linda Goossen, PhD, MT(ASCP), ASCLS Government Affairs Committee

Nearly 120 clinical laboratory professionals from 38 states met in Washington, D.C., March 18-19 for the 31st Annual Legislative Symposium. Sponsored by six professional organizations—the American Society for Clinical Laboratory Sciences (ASCLS), the Clinical Laboratory Management Association (CLMA), the American Society for Clinical Pathology (ASCP), the American Medical Technologists (AMT), the Association of Genetic Technologists (AGT), and the National Society for Histotechnology (NSH)—this annual two-day event first enables attendees to learn about the legislative and regulatory issues at the federal level that impact laboratories, laboratory professionals, and ultimately our patients. Second, attendees are prepared to take the issues to their senators and representatives and thus advocate on behalf of the profession.

Patrick Cooney, ASCLS legislative liaison; Michael McCarty, AMT legal counsel; and Matt Schultz, ASCP director of government affairs, spoke about the current political environment in Washington, which has been impacted by the recent elections and democrats holding a majority in the House or Representatives. Our meetings on Capitol Hill this year focused on three legislative or regulatory issues that currently impact clinical laboratories: (1) crisis in the clinical laboratory workforce; (2) flawed implementation of Section 216 of the Preserving Access to Medicare Act (PAMA); and (3) regulation of laboratory-developed tests (LDTs).

The importance of our six organizations speaking with one voice as we advocate for the laboratory profession and ultimately for our patients cannot be understated. Our united voice makes a much greater impact than individual voices.

Crisis in the Clinical Laboratory Workforce
A critical issue impacting clinical laboratories is the shortage of clinical laboratory personnel. The demand for the services of clinical laboratory personnel is growing, primarily due to the aging population and increased demand for laboratory services; retirement of the aging laboratory workforce; and new laboratory tests resulting from technology advances. With more than 10,000 new beneficiaries enrolling in Medicare each day, the Medicare population will rise from 20 million in 1970 to 80 million in 2030. Long-term and pervasive shortages of qualified professionals to fill many clinical laboratory and other allied health positions are expected.

The U.S. Department of Labor’s Bureau of Labor Statistics (BLS) anticipates needed growth of 12,000 new medical laboratory professionals per year to meet the growing demand. Yet, academic programs produced just 6,300 graduates in 2017, another factor leading to the crisis in the clinical laboratory workforce. Limited or no federal investment is being provided to address the workforce shortage in allied health.

In light of the current employment outlook for clinical laboratory personnel and other allied health professionals, as documented by the BLS, attendees urged their representatives in Congress to

• Establish a program of scholarships and loan repayment to alleviate shortages of clinical laboratory scientists and other allied health professionals. The scholarship and loan repayment program shall include a period of obligated service for recipients in a designated health professional shortage area.
• Establish a demonstration program to improve access to clinical education opportunities for allied health professionals under which an eligible hospital may receive payment for reasonable costs associated with the provision of qualified clinical training for clinical laboratory scientists and other health professionals.
• Require the secretary of Health and Human Services, in collaboration with the U.S. Department of Veterans Affairs, to identify which allied health occupations are in significant shortage on an annual basis.

On behalf of ASCLS, Patrick Cooney and staff are drafting the Allied Health Personnel Shortage Act, which contains the actions referred to in our visits to Capitol Hill, as listed above. We are currently looking for bill sponsors.

Flawed Implementation of PAMA
The second issue that we spoke to our representatives about is the flawed Preserving Access to Medicare Act of 2014 (PAMA). Signed into law on April 1, 2014, section 216 of PAMA includes the most extensive revision of the Clinical Laboratory Fee Schedule (CLFS) since it was established in 1984. The proposed rule required “applicable” clinical laboratories to report private payer payment rates and the test volume associated with those payment rates for laboratory services reimbursed under the CLFS. The intent of PAMA was to ensure true market-based pricing by setting the fee schedule to a weighted median of the collected data.

There were problems from the beginning. The Centers for Medicare and Medicaid Services (CMS) failed to publish the proposed rule in a timely manner; the statute required a final rule to be published by June 30, 2015, to enable laboratories to prepare their systems to submit data during 2016 for a January 1, 2017, initiation of the new fee schedule. The final rule was published June 23, 2016, in the Federal Register.

In addition, the proposed rule defined “applicable laboratory” as an entity with a National Provider Identifier (NPI), and this definition of applicable laboratory excluded virtually all hospitallaboratories and physician office laboratories, as well as over 50 percent of independent laboratories. Applicable laboratories also must have more than $12,500 in Medicare revenues from laboratory services on the CLFS and receive more than 50 percent of their Medicare revenues from laboratory and physician services during the data collection period. Excluding pricing data from hospitals and smaller laboratories allowed CMS to base industry-wide payment rates on data drawn from large reference laboratories that have significant economies of scale and, typically, much lower payment rates.

Given the definition of an “applicable” lab, 90 percent of the reported data came from independent laboratories; hospitals and POLs, which provide 44 percent of the laboratory services under Medicare, represented just 8.5 percent of the reporting entities; only 21 of the 6,994 hospital laboratories submitted data; only 1,106 of the ~ 236,000 POLS reported; and only 1.85 percent of the data collected came from laboratories serving rural areas.

The result of this bias in reporting is a significant lowering of the Medicare Fee Schedule as well as private payer rates for all laboratories, beginning in 2018. Small, local, physician office, and hospital labs that function close to the patient and thus can provide rapid results have already been impacted by this loss of revenue, to a level that has resulted in decreases in in-house testing, new technologies, funding for raises and benefits, and subsequently more tests being sent to reference labs. This situation will ultimately lead to the loss of jobs and the bankruptcy of clinical laboratories. Rather than protecting access to healthcare, these cuts are beginning to prohibit access to rapid diagnosis and treatment of disease. In the long run, patients will suffer. PAMA cuts will be particularly burdensome to the most vulnerable seniors, such as those in skilled nursing facilities, those managing chronic conditions, and seniors living in medically underserved communities.

For 2019, CMS has defined any hospital laboratory that uses the CMS 1450 14X to bill for Medicare Part B clinical laboratory tests as an “applicable laboratory” under PAMA. Under the final rule, laboratories, including physician office laboratories, are required to report private payer rate and volume data if they: (1) have more than $12,500 in Medicare revenues from laboratory services on the CLFS; and (2) receive more than 50 percent of their Medicare revenues from laboratory and physician services during a data collection period. That means a majority of hospital labs in the United States are required to report the prices they were paid by private health insurers to CMS. Laboratories will collect private payer data from January 1, 2019, through June 30, 2019, and report it to CMS by March 31, 2020.

While medical laboratories continue to grapple with the impact of reduced reimbursement rates under PAMA’s revised CLFS final rule, the new rules for what constitutes an “applicable lab” and the new reporting requirements that started January 1, 2019, add yet another level of complexity to reporting and compliance concerns. Rodney Forsman, assistant professor emeritus of lab medicine and pathology at the Mayo Clinic College of Medicine, in Rochester, Minnesota, told Dark Daily that “Laboratories must work to identify reporting concerns, billing and IT limitations, and identify current statutes and limitations to present to compliance officers and stakeholders. Failure to do so could leave labs liable for fines of up to $10,000 per day.”

Attendees urged their representatives in Congress to fix the flawed implementation of section 216 of PAMA. We urge Congress to: (a) make a statutory adjustment to the CLFS payments that provides short-term relief and allows time to revise the rate setting process conducted by CMS; (b) ensure a valid stratified random data sample is collected by CMS that represents all segments of the laboratory market; (c) require that data collection requirements streamline collection to reduce the burden on participating laboratories by focusing on data specific to the private market; and (d) revise PAMA statutory requirements to calculate final CLFS payment rates per code as a weighted mean proportionate to laboratory-type, market share, and geography.

Regulation of LDTs
The third issue brought forward during the Legislative Symposium was regulation of laboratory-developed tests (LDTs). In December of 2018, Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO), members of the House Energy and Commerce Committee, drafted a bill, called the Verifying Accurate, Leading-edge, IVCT Development Act (VALID Act of 2018). The VALID Act is an attempt to develop a new regulatory framework for LDTs.

Laboratory-developed tests are defined by the Food and Drug Administration (FDA) as in vitro diagnostic tests that are designed, manufactured, and used within a single laboratory. “ASCLS believes that LDTs must be regulated to ensure their accuracy and overall patient safety. Patients and health care providers need accurate, reliable, and clinically valid tests to make good health care decisions. Inaccurate or false tests results, or accurate measurements with an invalid claim regarding the test results’ relationship to a disease (clinical validity), can lead to substantial patient harm.”

ASCLS, representing clinical laboratory professionals, agrees that LDTs must be regulated to ensure their clinical validity, accuracy, and overall patient safety. Attendees asked their representatives in Congress to support the VALID Act of 2018.

On March 19, 2019, more than 115 clinical laboratory professionals rode the Washington, D.C., Metro system to Capitol Hill to tell our senators and representatives who we are, what we do, and to stress how critical our services are to the health of the people we serve. The experience of advocating on behalf of our profession is rewarding. The importance of our six organizations speaking with one voice as we advocate for the laboratory profession and ultimately for our patients cannot be understated. Our united voice makes a much greater impact than individual voices.

Linda Goossen is professor emerita at Grand Valley State University in Allendale, Michigan.

Alison Rossdeutscher, MLS(ASCP)^CM

Case History
A 70-year-old male was transported by EMSA to the hospital after falling in his home. The patient had an established diagnosis of chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS). This disease is an inflammatory disorder of the central nervous system and often presents as brainstem lesions.

The key characteristic of this disorder is that it is responsive to steroid immunosuppression therapy¹. The patient had been responsive to the steroids used to treat this disorder, but recently showed an increase in neurological symptoms. Initially believed to be a result of worsening CLIPPERS, the patient had been showing symptoms of progressive weakness, general malaise, and falling.

Upon admission to the hospital, an MRI scan was performed, during which a brain abscess was seen. The patient was placed on empiric vancomycin treatment and brought to the OR for abscess drainage. During surgery, tissue was collected and sent to the microbiology laboratory for culture.

Laboratory Identification
The Gram stain of the abscess tissue showed 2+ Gram-positive bacilli that were beaded and branching. The organism grew well on 5 percent sheep blood agar and chocolate agar within two days incubation. The colonies were dry, and the organism was modified acid-fast positive but negative for the Kinyoun acid-fast stain. The isolate was reported as presumptive Nocardia species and sent to a reference laboratory for full identification, where it was identified as Nocardia nova by MALDI-TOF.

Discussion
Nocardia species are saprophytic organisms found in the environment in places like soil and water. They are a suborder of the aerobic actinomycetes, and microscopically appear to be finely beaded and branching Gram-positive bacilli³. They can appear to have small branching hyphae but are not considered to be related to fungi and do not respond to antifungal treatment.

Due to their lack of virulence factors, they are most commonly seen in immunocompromised patients with decreased cell-mediated immunity, although they have been known to cause disease in some immunocompetent individuals². The most common site of infection is pulmonary. Of the extrapulmonary cases of nocardiosis, the central nervous system is the most common location for infection and often present as abscess formation. Symptoms are insidious in developing, and eventually present in patients as headaches, nausea, vomiting, seizures, or alteration in consciousness².

Laboratory identification can be difficult, as Nocardia are typically slow growing and take two to six days to initially grow on laboratory media. On a Gram stain, the organisms can resemble hyphae in some cases or acid-fast bacteria (AFB) in others. They are weakly acid-fast, and a stain using a weaker acid (0.5-1 percent sulfuric acid) compared to a typical acid-fast stain will yield a positive result. However, they will present as negative when subjected to a regular acid-fast stain (ex. Kinyoun stain). The colonies are often dry and breadcrumb-like. Current bacterial identification methods for Nocardia include 16S rRNA gene sequencing or mass spectrometry via MALDI-TOF³.

The treatment of choice for nocardiosis is a sulfonamide, which proves to be an active agent against most species of Nocardia³. In this case, after initial Gram stain results were reported, the patient was switched from empiric antimicrobial therapy to trimethoprim/sulfamethoxazole with success. This patient is a case in which induced immunosuppression due to inflammatory disease resulted in an opportunistic infection of Nocardia nova in the brain.

References

1. Reddy SM, Lath R, Swain M, and Ranjan A. Chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS): A case report and review of literature. Ann Indian Acad Neur. 2015;18(3):345-347.
2. Wilson JW. Nocardiosis: Updates and Clinical Overview. Mayo Clin Proc. 2012;87(4):403-407.
3. Mahon CR, Lehman DC, and Manuselis G. Textbook of Diagnostic Microbiology. Fifth Edition. Elsevier;2015;361-363.

Alison Rossdeutscher is a medical technologist at Saint Anthony Hospital in Mustang, Oklahoma.

Join the Microbiology/Public Health Scientific Assembly (member login required).

Creating Stronger and Financially-Sustainable Clinics in Haiti

Tim Randolph, PhD, MT(ASCP)

Randolph World Ministries, Inc., is operated by Tim and Liz Randolph out of their home. They make two annual medical mission trips to Haiti with teams that have included laboratorians, physician assistants, physicians, nurses, occupational therapists, and health information managers.

Randolph World Ministries, Inc., (RWM) is a faith-based, 501c3, medical mission ministry, founded in 2000 and currently operating in Haiti. Our primary mission is to improve healthcare in Haiti using a sustainable medical mission model. The focus of most medical mission groups is to deliver direct patient care during a typical 7- to 10-day mission trip. Although this medical mission model clearly benefits those served, there are several disadvantages often overlooked by mission team members.

Disadvantages of the Typical Mission Trip Model
First, and most notable to laboratory professionals, is the absence of laboratory services. From personal experience I estimate over 90 percent of medical mission groups—probably more like 99 percent—do not bring a lab. Second, due to limitations and fees for checked bags, most groups do not bring a comprehensive pharmacy. Third, most medical mission participants are not well versed in language and culture and do not know what diseases to expect due to a paucity of publications. Fourth, and most importantly, most teams set up a “mobile clinic” (often free) in an area where Haitian healthcare is available.

Haitians assume that North American mobile clinics provide superior care. Considering that local Haitian clinics have a functioning lab; a deeper pharmacy; and Haitian physicians who speak the language, know the culture, and are well versed in the conditions affecting their people, it is my observation this is usually not the case. I have observed well-intentioned Americans conduct a mobile clinic with nothing more than vitamins and NSAIDS. Although both are needed and helpful, most Haitian patients assume they received curative care from the bag of pills they received.

What is overlooked most by foreign medical mission teams is the impact mobile clinics have on the stability and survival of local Haitian clinics. Due to high unemployment and low wages, many Haitians lack the financial resources to access healthcare. However, most faith-based clinics treat patients regardless of their ability to pay. This creates a financial deficit for most Haitian clinics that is exacerbated when free mobile clinics attract paying patients away from local clinics. This problem is magnified in small villages and the countryside where most Haitians live, sometimes resulting in local clinic closures.

RWM’s Sustainable Model
The RWM model is to partner with local Haitian clinics to evaluate their procedures, equipment, and systems to improve their services through education, training, and materials support. This creates sustainable improvements to the local clinics that strengthen, rather than weaken, them financially. Currently RWM has 30 Haitian clinic partners scattered across Haiti with whom we communicate regularly and visit on a rotational basis biannually during our medical mission trips.

In addition to clinic partnerships, RWM conducts mobile clinics but only in areas where healthcare is not available, so as not to compete with local clinics. We also charge a nominal fee to dissuade healthy people from accessing our services. We always bring a large and comprehensive lab and pharmacy and we also recruit Haitian physicians to work with our teams creating a two-way consultation system for the more difficult cases. Our large network of clinic partners creates a deep referral system for patients with health concerns beyond our capabilities. Lastly, we donate our clinic fees back to the local leaders and encourage them to work with us to create a local clinic. To illustrate this model in action, 19 years ago our first clinic partner had two lab staff working in an 8’ x 8’ lab performing 13 tests. That same lab today has six staff and three lab rooms, each measuring 12’ x 15,’ and performs 42 tests.

Almost all Haitian clinics do not have the infrastructure (finances, electricity, clean water, refrigeration, climate control, waste disposal, etc.) to integrate modern systems. Therefore, RWM seeks to create new methods^1-3 or identify existing methods worldwide that are simple and inexpensive to be incorporated into Haitian clinics. Our initial goals are to find and correct errors through education and training, then introduce new methods, procedures, and systems that work within the limitations facing Haitian clinics to create stronger and financially-sustainable clinics to better serve patients well into the future.

The First Sickle Cell Center of Haiti
Our most recent undertaking is to tackle the problem of sickle cell (SCD) in Haiti. The prevalence of HbS in Haiti is about 15 percent⁴ but the birth rate and mortality rate for those with SCD are unknown. Based on African data⁵, we estimate the death rate of SCD in Haiti by age five years to be between 75 and 80 percent. By contrast, the mortality rate in the United States by age five years is <1 percent.^6-8

RWM seeks to solve this problem by developing the first Sickle Cell Center of Haiti to deliver comprehensive diagnostic testing, standard of care, and country-wide education to reduce mortality. Since the standard of care will be expensive and many patients will have limited finances, we plan to close this financial gap using a sustainable business model. Rather than ask for monthly donations indefinitely, we plan to open a chain of laboratory supply companies to sell a wide variety of laboratory supplies.

Based on what Haitian labs need, what is available to them for purchase, and current pricing, we are confident our laboratory supply companies can expand offerings to laboratories at reduced costs. This model will increase diagnostic capabilities and improve financial stability of Haitian clinics while creating jobs and generating profits to offset the costs to operate the Sickle Cell Center of Haiti. We are seeking start-up support to construct the Sickle Cell Center and to get the laboratory supply companies started. Once launched we anticipate profits from the laboratory supply companies will sustain the operating costs of the Sickle Cell Center, indefinitely.

Learn more about Randolph World Ministries, Inc.

References

1. A Method of HbF Determination for Potential Use in Underdeveloped Countries. Schumacher S and Randolph TR. Clin Lab Sci. Vol. 25/Number 4, Fall 2012, 212-218.
2. Novel Test Method (Sickle Confirm) to Differentiate Sickle Cell Anemia from Sickle Cell Trait for Potential Use in Developing Countries. Randolph TR and Wheelhouse J. Clin Lab Sci. Vol 25/Number 1, Winter 2012:26-34.
3. Development of a Falling Drop Hemoglobin Method for Resource-Poor Settings. Stumpf, MS, Sinha R, Golob N, Hoerner, Chen C, and Randolph TR. Clin Lab Sci. 2017;30(3):131-138.
4. Randolph TR. Estimated prevalence of sickle cell in northern Haiti. Clin Lab Sci. 2010;23(2):79-83.
5. Grosse SD, Odame I, Atrash HK, Amendah DD, Piel FB, and Williams TN. Sickle Cell Disease in Africa - A Neglected Cause of Early Childhood Mortality. Am J Prev Med. 2011;41(6): S398–S405.
6. CDC. Mortality among children with sickle cell disease identified by newborn screening during 1990-1994 – California, Illinois, and New York. DC, Morbidity and Mortality Weekly Report. 1998; March 13, 1998/vol. 47/No. 9:169-172.
7. Lanzkron S, Carroll CP, and Haywood C. Mortality rates and age at death from sickle cell disease: US, 1979-2005. Public Health Reports. 2013;128(2):110-116.
8. Yanni E, Grosse SD, Yang Q, and Olney RS. Trends in pediatric sickle cell disease-related mortality in the United States, 1983-2002. J Pediatr. 2009;154(4):541-545.

Tim Randolph is associate professor of medical laboratory science at Saint Louis University and founder of Randolph World Ministries, Inc.

The goal of the ASCLS Mentorship Program is to create a supportive environment that fosters a feeling of belonging and value as a member of the ASCLS community. Students, new professionals, and new members will develop meaningful relationships with mentors to promote personal and professional growth within ASCLS and beyond.

Mentors and mentees are paired up one-on-one and are free to discuss any goals or challenges the mentee wishes to work toward. In addition, supplemental information on everything from the history of ASCLS to how to plan a state meeting is provided to the pairs to further enhance discussion.

Mentors should be active ASCLS professional members and have at least five years of membership within the organization. To qualify as a mentee, applicants should be ASCLS members in the Developing Professional or Ascending Professional categories or be a new member/new professional that has been in the organization for less than five years.

Mentor-mentee pairs need to establish a positive, professional relationship with each other by establishing mutual trust and respect and maintaining regular interaction and consistent support. The Mentorship Committee requests you make contact with your mentor or mentee at least once a month using some form of communication medium that is determined by the mentor-mentee pair.

The formal program spans one year and after the program the pairs are encouraged to remain in contact. Mentors can sign up to be part of the program again and mentees are able to reapply as mentors themselves once they meet the mentor requirements.

Apply by July 15
The application period for the 2019-20 mentorship program is now open! Applications are due by July 15, 2019.

Mentee Application for those who would like to be connected with a mentor.

Mentor Application for those who would like to assist with the program.

If you have questions about the ASCLS Mentorship Program, please contact Heather McLaughlin, 2019-20 Mentorship Committee chair.

Testimonials:
“I’m new to ASCLS and there is a lot I don’t know. Being paired with someone who has been in ASCLS longer with more experience was very helpful.” - Mentee

“I wanted to join the mentorship program to gain more knowledge and experience from those who have been with the profession for years. It was nice to get a different perspective on issues from outside your own mentors within your state and local societies.” - Mentee

“I think a mentorship program provides a great opportunity for members who even just want to learn more about ASCLS. The more they learn the more likely they are to not only maintain their membership but also to become involved. This also provides an opportunity to help develop future leaders of the organization. Even though my mentee already held a leadership position, she had lots of ASCLS-related questions. I think she now understands the ‘why’ behind things she has to do, and it all makes more sense.” - Mentor

“I wanted to help guide new professionals through the complicated environment that is ASCLS and medical laboratory science in general. I wanted to be there for someone when they had questions regarding our organization as well as job related questions.” - Mentor