Premier receives prestigious CAP accreditation see more
Premier Medical Laboratory Services (PMLS), an advanced medical diagnostic laboratory offering over 2,000 clinical tests, is announcing today their receipt of the College of American Pathologists (CAP) Accreditation. As one of the most stringent of laboratory certifications, CAP Accreditation verifies that the laboratory meets all required standards from CLIA, the FDA, and OSHA. With this certification, PMLS is regarded as one of the world’s top-ranked labs for medical diagnostics which exceeds the industry’s clinical laboratory standards.
“Quality medical diagnostics are integral for successful patient outcomes,” stated Kevin Murdock, CEO of PMLS. “With that in mind, we are meticulous in our pursuit to deliver accuracy and consistency. That’s why we underwent the CAP Accreditation process - to ensure that we’re an industry leader for the doctors and patients that rely on our testing capabilities. We’re proud of our team that performs at such an extraordinary level and to have achieved this highly regarded certification.”
In order to receive CAP Accreditation, a laboratory is required to first attain Clinical Laboratory Improvement Amendments (CLIA) certification. CLIA is regulated by the Centers for Medicare & Medicaid Services (CMS), The Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) to set the standards for which a clinical diagnostics lab must operate in the US. Once this certification is attained, a laboratory like PMLS can apply for CAP Accreditation and undergo a rigorous inspection of their laboratory operations to further confirm that precision, accuracy, safety, and best practices are in place. This sets CAP Accredited laboratories apart from most that are in operation today.
Along with this achievement, PMLS has reached one of the highest testing capacities in the US, processing up to 100,000 tests per day. They are a trusted testing partner of state health departments, Health and Human Services surge sites, large corporations, professional sports teams, universities, and health systems throughout the country. With an in-house research and development team of PhD scientists, they are continually expanding their diagnostic services. Now, as a CAP Accredited laboratory, doctors and patients can be further assured that PMLS provides the industry’s highest standards for accurate, cutting edge, and reliable diagnostics to improve patient lives.
For more information on Premier Medical Laboratory Services, please visit www.premedinc.com.
ABOUT PREMIER MEDICAL LABORATORY SERVICES
Premier Medical Laboratory Services® is fully certified by all major accrediting organizations including Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) Accreditation. Utilizing the latest equipment, including liquid chromatography mass spectrometry (LCMS), molecular, Next Generation Sequencing (NGS) and other technology, we provide high analytical standards and accurate interpretations along with unsurpassed turnaround times for clinics and physicians. As an industry leader in molecular diagnostics, our in-house team of PhD scientists, laboratory staff, and customer care team deliver accuracy and reliability that is unmatched. We are innovators and thought leaders, moving the medical industry forward with the latest in science and technology. As a top of the line, highly complex diagnostics lab, we are committed to help our clients meet the highest standards in patient care and specialize in the following areas:
• General and Routine Chemistry's
• Advanced Cardiovascular Testing
• Allergen – Specific IgE Blood Testing
• Women’s Health
• Patient Rx Monitoring
• Wellness Panel
• Covid-19 Testing
A new topic from the Nelson Mullins Idea Exchange see more
The Centers for Medicare & Medicaid Services (CMS or the Agency) announced on January 19, 2022 that it was delaying the publication of a Clinical Laboratory Improvement Amendments of 1988 (CLIA) final rulemaking by one year. The goal of this rulemaking is to update clinical laboratory proficiency testing (PT) regulations. PT is the testing of unknown samples sent to a clinical laboratory by a CMS-approved program. Such testing is used by CMS, accreditation organizations, and clinical laboratories to verify the accuracy and reliability of a laboratory’s testing activities.
CMS published the PT proposed rulemaking in February 2019. Under the Social Security Act, a Medicare final rule must be published within three years of the proposed rule (absent exceptional circumstances). CMS originally slated the PT final rulemaking for publication in February of this year. Now, the Agency is expecting finalization of the rule by February 2023.
The PT rulemaking is intended to address current analytes and newer technologies by updating CLIA regulations (42 CFR Part 493). In the February 2019 proposed rule, CMS proposed, among other items:
- Requiring PT for an additional 29 analytes;
- Mandating a minimum of 10 laboratory participants before a PT program offers an analyte;
- Increasing the number of challenges per PT event for certain types of testing (e.g., susceptibility or resistance testing for each microbiology subspecialty would increase from one to two challenges); and
- Requiring that PT programs limit participants’ online submission of PT data to one submission or that a method be provided to track changes made to electronically-reported results.
CMS received over 100 comments concerning the proposed rulemaking. In delaying the publication of the final rulemaking by a year, CMS cited the COVID-19 public health emergency. The Agency is currently prioritizing the “publication of notices relevant to COVID-19 and to provide guidance to laboratories involved in COVID-19 testing.” Because of these ongoing public health demands, CMS explained that it cannot meet the original February 2022 deadline.
According to the Fall 2021 Unified Agenda, CMS is scheduled to publish another clinical laboratory-focused proposed rulemaking in March of this year. That rulemaking will focus on updates to the clinical laboratory personnel, histocompatibility, and alternative sanctions regulations as well as CLIA-related program fees. Because of the COVID-19 public health emergency, it is unclear if the Agency will postpone publication of this proposed rulemaking as well.
Nelson Mullins continues to closely monitor developments related to clinical laboratories and CLIA regulations. For questions or assistance, please contact Christopher Hanson.
Life sciences firm seeking to add hundreds of new employees see more
Premier Medical Laboratory Services, has recently reported a rapid increase in medical testing demands coming to their laboratory – the amount of COVID-19 tests alone being processed at their Greenville, SC facility has jumped 250% in the last two weeks. Much of this is due to the Omicron variant, which first made landfall in the US at the beginning of December and is now the dominant strain of the virus in the nation. With this influx of tests poses an immediate need for hundreds of Upstate employees to be hired at the medical laboratory.
“Throughout the pandemic we’ve been proactive in fulfilling our staffing needs,” said Kevin Murdock, CEO and Founder of Premier Medical Laboratory Services. “To ensure that we continue to properly meet testing demands amid this new surge, we are looking to vastly expand our team and to provide jobs in the community.”
PMLS is a CLIA and COLA certified laboratory. They are the choice processing lab for Health and Human Services testing sites, and the trusted COVID-19 management partner for professional sports teams, schools, colleges, large corporations, and health departments across the nation. With an expanding team, they are inviting members of the Upstate community to join them in providing vital services and information, helping to battle COVID-19 and its new variants and to improve the future of healthcare with advanced medical diagnostics. Currently, the lab is looking to fill the following positions:
Lab Data Entry Clerk
- NO EXPERIENCE NEEDED
- Job duties include entering patient information into a computer system, scanning barcodes, and helping with any other lab assistant needs
- Protective gear and all training are provided by the lab
Job Type: Part-Time; Pay: $15 per hour
Medical Laboratory Technician
Responsible for performing medical tests in the Molecular Lab. Does not need to be certified if a degree in Chemistry or Biology have been attained.
- Collect and organize blood, tissue, and other bodily fluid samples from patients
- Prepare samples for routine testing and analysis
- Properly record results for further analysis and easy reference
- Monitor inventory samples and supplies
- Maintain a clean work environment
- You must have experience as a Medical Technologist (ASCP Certificate that is CURRENT is a plus!)
- BS in Biology or Chemistry is also helpful
- Familiarity with common medical terminology
- Experience in a laboratory setting
- Strong organizational skills
Job Type: Full-time; Pay: $18-$22 per hour
- ***MUST HAVE EXPERIENCE WITH MANUAL EXTRACTION PROCESSES***
- Has earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution
- Has at least 2 years of current laboratory experience, in moderate complexity testing (Chemistry, Hematology, Urinalysis)
- Has 2 years of laboratory training or experience in high complexity testing (Allergy and/or Molecular)
Job Type: Full-time; Pay: $24-$28/hr
All positions located in Greenville, SC. Please email: HR@DIVMEDINC.COM to apply. For more information, please visit www.PreMedInc.com or call 1.866.800.5470.
ABOUT PREMIER MEDICAL LABORATORY SERVICES
Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS) easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry. Their expansive testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women's Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and a first of its kind predictive genetic test for type II diabetes, DIABETESPredict. For more information, please visit www.PreMedInc.com.
Company investing $5 million and creating 91 new jobs see more
KIYATEC, Inc. today announced plans to expand operations in Greenville County. The $5 million investment will create 91 new jobs.
Founded in 2005, KIYATEC, Inc. is a commercial stage cancer diagnostics company born from technology developed at Clemson University, creating transformative solutions for cancer patients using functional precision oncology. KIYATEC, Inc. recently launched its first commercial assay 3D Predict™ Glioma for use in glioblastoma (commonly known as GBM) and other brain cancer patient care.
The company established its Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory and began clinical studies in 2015, developing proprietary “ex vivo” 3D cell culture technology platforms to accurately model and predict patient-specific response to approved and investigational cancer drugs targeting a spectrum of solid tumors.
“Securing testing capacity to bring our testing to thousands, then tens of thousands of cancer patients is a business decision that positions us to win and increases our competitive advantage. As a Greenville-based life sciences company, KIYATEC benefits from all this area has to offer including its highly-educated labor force, excellent quality of life for our employees, competitive cost profile and business-friendly environment,” said KIYATEC, Inc. Chief Executive Officer Matt Gevaert, Ph.D.
Located at 2 N. Main Street in Greenville, KIYATEC, Inc.’s downtown facility will allow the company to expand its existing clinical testing operations and drug development services which are co-located with the Cancer Institute at nearby Prisma Health’s Memorial Campus. This new facility will be the anchor tenant of the city of Greenville’s new Innovation District.
The new offices are expected to be operational by January 2022 and the CLIA-certified laboratory by April 2022. Individuals interested in joining the KIYATEC, Inc. team should visit the company’s website.
Clinical laboratory investing over $3 million, creating 54 new positions see more
Luxor Scientific, LLC (Luxor), a full-service clinical laboratory serving customers nationwide, today announced plans to expand operations in Greenville County, South Carolina. The more than $3.2 million investment will create 54 new jobs.
Luxor is a CLIA and CAP-accredited, and DEA registered full-service clinical laboratory that specializes in infectious disease, immunology, integrated oncology and genetics, chemistry and hematology research. The company is comprised of recognized experts in providing cutting-edge scientific solutions to better serve the health care community.
“We are excited to continue Luxor Scientific’s growth and investment in Greenville. Our team has established itself as one of the best serving our community, and we are glad to be adding to our capability and to our numbers,” said Luxor Scientific, LLC Chief Strategy Officer Jay Flanagan. “We are ever thankful to Greenville County and the S.C. Department of Commerce for helping us make this expansion a reality.”
Located at 1327 Miller Road in Greenville, Luxor’s expansion will increase the company’s research and development capacity to better serve its clientele.
“Luxor’s expansion highlights the tremendous success life science companies are seeing throughout South Carolina,” stated South Carolina Governor Henry McMaster. “This investment will bring enhanced care and innovation to South Carolina’s health care community while also creating high-quality jobs in Greenville County.”
Luxor was founded in 2016 by brothers Ryan and Jay Flanagan, and has grown to more than 140 employees, including world-class PhD science officers on its staff. Among their clients are S.C. Department of Health and Environmental Control (DHEC), the S.C. Department of Agriculture, the US Drug Enforcement Administration, private sector employers, hospitals, universities, clinics, and others.
“When companies like Luxor Scientific operate in South Carolina and find success, it highlights the diversity of our state’s economy. We congratulate Luxor on this expansion in Greenville County and look forward to watching their continued work in South Carolina,” added Secretary of Commerce Harry M. Lightsey III.
The latest expansion is expected to be completed by April 2022. Individuals interested in joining the Luxor team should visit the company’s contact webpage.
“We are always pleased when a homegrown company like Luxor chooses to expand here in Greenville County, commented Greenville County Council Chairman and Greenville Area Development Corporation Board Member Willis Meadows. “Luxor’s leading-edge expertise in life sciences has made them a strong resource to our state and to communities across the country already, and we are delighted that they have chosen to continue that growth from right here in Greenville County.”
# # #
The Greenville Area Development Corporation is a non-profit organization established by Greenville County Council to promote and enhance the economic growth and development of Greenville County. Since its founding in 2001, GADC efforts have resulted in the creation of over 30,000 new jobs, nearly $6 billion in capital investment, and a cumulative economic impact of over $55 billion in Greenville County, SC -- including an economic impact of more than $6 billion annually. To learn more, please visit www.goGADC.com or call (864) 235-2008. To learn more about workforce opportunities, visit www.jobsingreenvillesc.com.
PMLS picks new Chief Commercial Officer for fast-growing organization see more
Premier Medical Laboratory Services (PMLS) is announcing today Jeff Schmalz as their new Chief Commercial Officer. At PMLS, Jeff will be focusing on the major disciplines impacting lab growth including partnerships, product development, clinical outreach, sales infrastructure, customer service and marketing. With 35 years of experience in multiple healthcare organizations, he brings extensive knowledge in the diagnostics and reference lab markets.
In his latest role, he led the segment marketing and business development team responsible for integrating specialty labs, technology, and test launches that contributed to several hundred million in additional revenue growth. Jeff also oversaw the launching, branding, and commercializing of Lab Developed Tests (LTDS) over a period of 15 years for 25 test classes resulting in over $400M per year in revenue. He has founded, developed, and launched international partnerships to carry out his sales initiatives and maximize overall market share.
“I chose to work at Premier Medical Laboratory Services because they’re an innovative and nimble company with all of the components in place to make them a national leading specialty lab,” said Jeff Schmalz. “They lead with a forward-thinking approach to unmet needs within the healthcare industry and continually build on their capabilities to bring the most advanced medical diagnostics services for better patient outcomes…and that’s something I want to be a part of and advance forward.”
As a graduate and scholarship athlete from the University of Maryland, Jeff pursued an executive management MBA curriculum from the Kellogg School of Management. Since then, he has served as a board member for the Biomedical Marketing Association and successfully launched products at Abbot, Chiron, LabCorp, Digene, Bayer and Qiagen. He managed a team of 53 segment leaders, product managers, and marketing communication strategists by positive motivation, leading by example, and empowering them to make decisions and take initiative.
“We are at an integral phase in our growth here at Premier Medical Laboratory Services as a top lab with the mission to bring the most advanced diagnostics to our nation,” said Kevin Murdock, CEO and Founder of PMLS. “The level of talent and experience that Jeff Schmalz possesses will help us tremendously in fulfilling our vision of improving patient lives.”
ABOUT PREMIER MEDICAL LABORATORY SERVICES
Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS) easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry. Their expansive testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women's Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and a first of its kind predictive genetic test for type II diabetes, DIABETESPredict. For more information, please visit www.PreMedInc.com
Senator views progress one year later see more
Senator Tim Scott’s senior staff visited Diversified Medical Healthcare (DMH) headquarters, touring the Greenville, SC facility which houses four healthcare companies making a national impact. Premier Medical Laboratory Services (PMLS), CPT Medical, OnGen, and Vessel Medical serve as a large-scale molecular diagnostics lab, clinical test kit manufacturer, surgical kit manufacturer, medical data management software firm, laboratory equipment supplier, and PPE kit supplier.
Just one year ago, Diversified Medical Healthcare’s laboratory, PMLS, became the first lab validated for COVID-19 testing in South Carolina alongside their other advanced clinical diagnostics offerings. Providing an inside look at their 40,000 sqft faciltiy for the US Senator’s staff, DMH founder, Kevin Murdock introduced them to the company’s research and development team of Ph.D. scientists and over 450 employees as well as showcased the cutting edge laboratory automation equipment which has allowed them one of the highest laboratory testing capacities in the nation.
“From leading research and innovation to generously donating PPE for our front line workers, Diversified Medical Healthcare has been a valuable partner for South Carolina as we’ve worked to get through the pandemic,” said Senator Scott. “Their efforts highlight the life-saving impact of American innovation, and I am proud of the work they have done.”
The senator’s staff toured the laboratory where over 1,000,000 COVID-19 tests were processed during the last year and data has been managed by their laboratory information management software developed in-house. They viewed CPT Medical where over 6,000,000 COVID-19 testing kits and viral transport media have been manufactured and saw the Vessel Medical facility where hundreds of thousands of customized PPE supply kits were assembled and distributed.
In the laboratory, PhD Scientist, Vidhya Narayanan spoke with them about a large scale genomic sequencing that Premier Medical Laboratory Services is conducting for the surveillance of new variants of the Sars CoV-2 virus. As the only laboratory in the US fully automated for Next Generation Sequencing, PMLS expects to sequence up to 84,000 specimens per week. This will be a critical contribution in preventing a future surge of new COVID-19 variants.
“It was a high honor to have Senator Tim Scott’s team here and to show them all that we’re doing right here in South Carolina to improve healthcare across the US,” said Kevin Murdock, founder of Diversified Medical Healthcare. “Senator Tim Scott has done much to improve healthcare and create jobs, and those are two of the driving forces behind what we do here as well.”
The visit of Senator Tim Scott’s staff, comes just two weeks after SC State Representatives, Bobby Cox and Bruce Bannister visited the facility to view all that DMH is doing to contribute to healthcare in the state of South Carolina and the nation.
Over the past year, Diversified Medical Healthcare companies have also:
- Reached one of the highest testing capacities in the nation with the capability to process over 300,000 tests per day
- Developed medical data management software that communicates directly from laboratory equipment for faster delivery of data to healthcare providers and patients
- Developed Virtual Lab, an innovative solution to laboratory infrastructure limitations which allows other labs to utilize PMLS’ testing capacity, 450 employees including a research and development team of PhD scientists, and top of the line lab equipment
- Developed Lab in a Box, turnkey lab equipment for other labs, hospital systems, and large organizations that comes with everything needed for professional laboratory level diagnostics for COVID-19, Flu A and B, upper respiratory, STD/UTI, cancer risk screening, pharmacogenomics, and antibiotic resistance testing
- Shifted production to add in-house manufacturing of COVID-19 testing kits
- Achieved the capacity to produce 60,000 COVID-19 testing kits per day
- Become the official COVID-19 testing lab for the United Soccer League (USL) and Division I/Division II teams in 7 collegiate conferences as well as large schools and business organizations across the US
- Become the processing lab for Human Health Services surge sites and state health departments in South Carolina, Arizona, Utah, and North Carolina
- Become the Blue Cross Blue Shield preferred COVID-19 testing lab in Texas, South Carolina, and North Carolina
- Donated hundreds of thousands of masks to local law enforcement, paramedics, fire departments, hospitals, and the Shriners organization and has provided free testing to first responders during the pandemic
For more information, please visit www.divmedinc.com or call 866-521-7541.
ABOUT DIVERSIFIED MEDICAL HEALTHCARE
Diversified Medical Healthcare (DMH), a holding company with four subsidiary healthcare companies, Premier Medical Laboratory Services (PMLS), CPT Medical, OnGen, and Vessel Medical. PMLS is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including Clinical Laboratory Improvement Amendments (CLIA) and COLA. PMLS testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women’s Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and a first of its kind predictive genetic test for type II diabetes, DiabetestPredict. CPT Medical, Inc. has manufactured surgical custom and standard procedure trays, packs, and kits assembled to fit specific needs and requirements for over 15 years. Now, CPT Medical also manufactures and distributes COVID-19 testing kits with the FDA recommended viral transport medium as well as nuclease free water for laboratories. OnGen is an advanced Laboratory Information System that automates laboratory processes for higher efficiency, accuracy, and profitability. Vessel Medical, since its inception in 1991, has been committed to providing physician’s offices, hospitals, laboratories and their employees with the right workflow solutions, medical supplies, and medical equipment for their needs. Included in their medical equipment offerings is ‘Lab in a Box,’ turnkey laboratory equipment that can turn a 600 sq. ft. room into a COVID-19 testing facility with the capacity to process up to 12,000 tests per day within 24 hours. For more information, please visit www.divmedinc.com or call 866-521-7541.
Life sciences executive named to national NAMB Board see more
Nephron Pharmaceuticals Corporation today announced CEO Lou Kennedy as a new member of the National Association of Manufacturers Board of Directors.
Kennedy, who was elected on Monday, joins the NAM Board to bolster the association’s leadership in policy advocacy, workforce solutions, legal action, operational excellence and news and insights. She will help the industry advance an agenda that promotes growth and prosperity for all Americans.
“I could not be more excited and honored to join the board,” said Kennedy. “Our team has been fortunate to work with NAM over the last few years on critical issues, from COVID-19 to workforce development, and we are always impressed by the results NAM delivers for its members, as well as for employers and employees across the nation.”
NAM and its members are at the forefront of every important policy debate for manufacturers and have led the nation’s response to COVID-19.
Board members play a key role in the NAM’s “Creators Wanted” campaign, a member-driven initiative to inspire and drive more Americans to pursue careers in modern manufacturing.
“Lou Kennedy is a recognized leader in our industry, and the NAM will be stronger thanks to her service on our Board of Directors,” said NAM President and CEO Jay Timmons. “Manufacturers are the driving force behind our economic recovery and our fight to defeat COVID-19. We are working with lawmakers to ensure they deliver the relief America needs and the long-term policy work on issues like infrastructure investment, immigration reform, trade expansion and workforce development. We will also defend the progress we’ve made on tax reform and regulatory certainty to ensure we can keep our promises to invest in our people and communities and build the strongest economy possible. The NAM’s mission is to ensure we always keep moving forward, and Lou will bring invaluable insights as we advocate for the men and women of our industry and advance the values that have made America exceptional and our industry strong — free enterprise, competitiveness, individual liberty and equal opportunity.”
A West Columbia, S.C.-based company, Nephron is a nationwide leader in the development and production of safe, affordable generic inhalation solutions and suspension products. The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate drug shortage needs. The company recently opened a CLIA-certified diagnostics lab, conducts COVID-19 tests and administers vaccines. Nephron announced a new $215 million investment and expansion in July, signaling a new era of unprecedented growth, including the establishment of a vaccine production facility.
The National Association of Manufacturers is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 12.2 million men and women, contributes $2.32 trillion to the U.S. economy annually and has the largest economic multiplier of any major sector and accounts for 63% of private-sector research and development. The NAM is the powerful voice of the manufacturing community and the leading advocate for a policy agenda that helps manufacturers compete in the global economy and create jobs across the United States. For more information about the NAM or to follow us on Twitter and Facebook, please visit www.nam.org.