Diversified Medical Healthcare (DMH), a holding company with four subsidiary healthcare companies, Premier Medical Laboratory Services (PMLS), CPT Medical, OnGen, and Vessel Medical, has provided leading-edge solutions to combat COVID-19 nationally, addressing supply chain gaps and infrastructure restrictions caused by the virus. Their molecular diagnostics laboratory, PMLS, became the first lab in South Carolina validated as an independent COVID-19 testing lab one year ago. Just as PMLS achieved this validation for testing shortly after the first case was reported in the US, they continue to meet demands caused by COVID-19 as they arise with their laboratory staff of over 360 employees and in-house research and development team of Ph.D. scientists. Along with large scale testing via state of the art automated lab equipment, DMH companies developed advanced software for most efficient data management, distributed customized PPE supply kits, and manufactured COVID-19 testing kits as well as viral transport medium that properly preserves specimens during transit. 

“Since COVID-19 became a threat to our nation, we quickly streamlined our workflow, hired employees, validated various coronavirus assays, and purchased the equipment needed to test a large volume of specimens with the highest quality standards,” said Kevin Murdock founder of Diversified Medical Healthcare. “With our laboratory having one of the highest testing capacities in the nation, an in-house medical manufacturing firm, a lab equipment company, and data management software company, we feel that it’s imperative to do our part to help keep the country open and our citizens safe.”

At this one year mark, PMLS has processed over one million (1,000,000) tests to determine COVID-19 results for patients nationwide. With their highly advanced laboratory information management system (LIMS) created by OnGen, data is communicated directly from high throughput laboratory equipment for fast, accurate storage and delivery of data to healthcare providers and patients. Many of PMLS’ lab processes are automated to allow them a testing capacity of 300,000 tests per day. With this scalability, PMLS has enabled other laboratories and testing sites to increase their testing capacity and turnaround of results with Virtual Lab. An innovative COVID-19 testing solution to overcome laboratory infrastructure restrictions, Virtual Lab allows these facilities to utilize PMLS’ fully-automated robotic workflow and team of 360 employees to largely increase their testing capacity and efficiency while bypassing the need to purchase new equipment or endure waiting time of weeks or more for shipping, installation, and validation. Along with helping other labs, hospital systems and large organizations to test more patients, Diversified Medical Healthcare has 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.

As another means to aid laboratories, healthcare systems, and large organizations in the expansion of their COVID-19 testing, Vessel Medical offers Lab in a Box, turnkey lab equipment 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. Developed by leading scientists and technicians in partnership with Hamilton Company, Thermo Fisher, and Grenova, Lab in a Box enables a high capacity of onsite diagnostics for hospitals, expanding laboratories, schools, and large companies in need of quick and accurate testing results. With precision robotic instruments, lab in a box includes high throughput liquid handling along with automated, custom-programmable pipetting that decreases human error and result turnaround time.

Another DMH company, CPT Medical, shifted their production of surgical supplies to include manufacturing of COVID-19 testing kits since the beginning of the pandemic. CPT Medical is now capable of manufacturing 60,000 test kits per day and works in conjunction with PMLS to offer customizable testing to large organizations. Some of the large organizations that PMLS has partnered with as the official COVID-19 testing lab are 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. PMLS is also the processing lab for Human Health Services surge sites and state health departments in South Carolina, Arizona, Utah, and North Carolina and is the Blue Cross Blue Shield preferred COVID-19 testing lab in Texas, South Carolina, and North Carolina. Through all of these partnerships, PMLS has continued in their reputation of delivering the most advanced testing with rapid, reliable results, and diligent customer care.

Now, as vaccines are administered and restrictions on social distancing are being lifted, PMLS is conducting a critical large scale genomic sequencing for the surveillance of new COVID-19 variants, taking proactive measures so that a future surge of a mutated Sars CoV-2 strain is less likely to occur. The data collected from genomic sequencing can help pharmaceutical companies to stay ahead of the variants and make any changes needed to the current vaccines and treatments for higher efficacy and best patient outcomes. With PMLS’ high throughput genomic sequencers and library prep instruments that automate the library prep and sequencing process, a much higher capacity for genomic sequencing is achieved and margins of human error are drastically reduced. By sequencing an exponentially higher amount of specimens, PMLS is better equipped to provide meaningful analysis with larger amounts of data and faster turnaround times for the effective surveillance of SARS-CoV-2. PMLS is in discussions with the CDC and multiple states across the nation to provide COVID sequencing services at ports of entry and local and regional hotspots.  Along with this and their previous accomplishments, more groundbreaking COVID-19 solutions by Diversified Medical Healthcare are soon to be announced.

PMLS is an award-winning laboratory focused on delivering clinically meaningful results for better patient outcomes. As an industry leader in molecular diagnostics, PMLS is fully certified by top laboratory accrediting organizations, including CLIA and COLA. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry. The group continues to move the medical industry forward with the latest in science and technology and is committed to helping clients meet the highest standards in patient care.

“We are thrilled to bring on PMLS as our Official Health and Wellness Testing Supplier,” said Josh Keller, USL Sr. Vice President of Corporate Development & Partnerships. “The health and safety of everyone in our USL ecosystem is our top priority as a league. Having PMLS onboard to provide reliable testing helps us ensure we are operating in the safest environment possible as we return to play for the 2021 season.”

“Just as PMLS is improving healthcare through advanced molecular diagnostics, USL is cultivating talent and improving the game of soccer throughout our nation,” said Kevin Murdock, founder of Premier Medical Laboratory Services. “We look forward to supporting the health of the league and keeping their athletes on the field with fast, accurate COVID-19 testing they can count on. It’s an honor to partner with them.”

Diagnostic tests

Although many diseases affect millions of people around the world, there are roughly 4,000 diagnostic tests that are available today. With the advancements in technology and automation, it is now easy to use tests, and the results are more accurate ensuring that precise results are produced on time. Diagnostic tests whether done in the hospital or independent laboratories, at physician offices or home are what caregivers and physicians depend upon to prevent, diagnose, treat and manage different conditions and make an impact on the lives of millions of people.

Diagnostic test categories

Diagnostic tests can be categorized into 5 groups: molecular (a study of RNA and DNA), general chemistry (measurement of base compounds), hematology (a study of blood), microbiology (Detection of disease-causing organisms) and immunochemistry (matching of antibody-antigen response). In vitro, diagnostic tests are among the most common tests done in modern health care provision. It involves the tests done on samples taken from the body like blood, spinal fluid, urine, saliva, and DNA. The complexity of the tests differs with the simple ones being done at home or physician offices and complex ones done in large laboratories using expensive equipment and reagents together with sophisticated methods that require highly skilled technicians and personnel to perform and interpret the results.

Indications of diagnostic procedures

So, what are medical indications that warrant a diagnostic procedure? Usually, you will feel that there is a problem with a part of your body system when you have signs like pain, inability to do things that you have always been able to do, fever and fatigue among other signs of disease. The first thing to do under such circumstances would be to see a doctor and express your complaint. To determine your condition, the doctor or physician will need to establish any deviation from what is known to be normal body functioning. This can be described in terms of physiology, anatomy, psychology, homeostasis and pathology. This simply means determining your particular deviation parameters from the normal and the degree of deviation that may warrant further diagnostic procedures to be done.

Importance of diagnostic tests

There are over 7 billion diagnostic tests done in the United States each year, and the numbers are growing each day as more and more people demand diagnostic tests because they are becoming aware of their quality indicators. Apart from diagnosis, diagnostic tests help in:

• Early detection of diseases to prevent it,
• Identifying the stage of disease to determine its severity,
• Drug selection and treatment monitoring for accurate and targeted treatment to suit individual needs and
• In disease monitoring and management to evaluate the success of treatment and the need for further tests and treatment.

Clinical diagnosis made based on medical signs, and patient information should be accompanied with the performance of diagnostic tests for accurate diagnosis and respective administration of treatments and therapy and to reduce cases of diagnostic errors.

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Medical supplies are vital instruments that help you administer the tests account for all of the findings. The next section shows some widely used equipment for POL (Physician Office Lab) testing.

• BC-3200 Auto Hematology Analyzer is FDA approved and features a Cap Piercing Chamber that will hold up to 4 types of tubes. The design helps you avoid contamination, which would be detrimental to your study. You also get fast speeds for testing, easy maintenance, and accurate results from the user friendly software. This is one of the best analyzers available.
• Envoy 500 is one of the fastest bench-top analyzers by performing up to 570 tests per hour. This vessel save you money and time and has a four-parameter Dry ISE, positive sample identification, and a built in touch screen with a bright LCD monitor. All of your results can be stored in memory to be easily displayed at just a touch. Also the pre-programmed parameters are already programmed into the software.
• Cardiochek P-A is a blood testing instruments which can be used to check diabetes and cholesterol. It’s like having a health management system right in the palm of your hand. Easy to use with fast results in less than a minute.

With the right testing capabilities and equipment, the sky is the limit. (CLIA) Waved Testing is advanced and has you covered. By following all protocols, your business can be up and running on all cylinders. For more info on medical devices, go to https://www.vesselmedical.com/cardiochek-p-a/.

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Proper (CLIA) Waived Lab Testing & Protocols

CLIA– Clinical Laboratory Improvement Amendments is to ensure timeliness, accurate, and reliability in patient testing. This act falls under strict, high quality standards, wherever the tests were performed. This agreement was passed in 1988, but the regulations weren’t passed and published until late 1992 of the Federal Register. The complexity and make-up of the tests mainly the requirements and not where the tests were performed. Let’s take a closer look at some of the terms.

So What Is A Waived Test?

• Waived Tests are classified as simple laboratory procedures and exams, which has a slight risk of error related results. By determining these tests, The Food And Drug Administration has a strict criteria of the application process and how it’s run. These tests are to be very simple and to minimize risk of error.

What’s A Laboratory?

• Laboratories are testing facilities that involves the proper testing of human body material or substances. The purpose is to provide diagnostic information, treatment, impairment, and assessment of health for people. Information on labs and tests, go to https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/. for more information and knowledge.

If you are a person in the medical field, doctor/nurse and you have multiple locations and want to perform Waived Testing, you’ll need a (CLIA) Certificate for each location you perform testing. The only way around this matter is if you qualify for an exemption. If there is no fixed or physical location and you move from site to site such as Health Screening Fairs, Mobile Units, or places of Temporary Residence, may be covered the Certificate of Primary Site. Also any local, federal, or state labs owned by the government, with limited health testing, can file single applications as needed.

You can’t perform any waived testing until after you have applied for and received a fee coupon. Just follow the directions on the coupon for this payment. Your certificate will be mailed to you after the CMS receives your payment in full. Some states agencies have slightly different requirements, so check with your state agency.

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