HOME | MEDICAL LABORATORY OBSERVERCONTINUING EDUCATIONWEBINARSWHITEPAPERSEVENTSCAREERSADVERTISE Articles, news, products, blogs and videos from Medical Laboratory

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MAGAZINES | MEDICAL LABORATORY OBSERVERINFORMATION TECHNOLOGYMANAGEMENTDISEASEEVENTSCONTACT USWHITEPAPERS mlo-online.com features online exclusive content as well as feature articles and stories from our print publications. Access digital editions and recent issues for our magazine here. AMA ANNOUNCES UPDATE TO COVID-19 VACCINE CPT CODES The American Medical Association (AMA) announced that the Current Procedural Terminology (CPT) code set has been updated by the CPT Editorial Panel to include vaccine and administration codes that are unique to the COVID-19 vaccine candidate under development by Novavax. MLO’S 2021 ANNUAL SALARY SURVEY OF LABORATORY According to the results of Medical Laboratory Observer’s 2021 annual salary survey of laboratory professionals, average salary has increased and job security remains high, but the COVID-19 pandemic has exacerbated the profession’s staff shortages, with 80 percent of respondents noting shortages having a “moderate to large impact” on operational efficiency. LEGAL LIABILITY IN URINE DRUG TESTING: COULD YOUR LAB BESEE MORE ON

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PERKINELMER TO ACQUIRE IMMUNODIAGNOSTIC SYSTEMS PerkinElmer and Immunodiagnostic Systems have reached an agreement on the terms of an all-cash offer in which PerkinElmer will acquire IDS for approximately $155 million. REVIEW OF PLATELET ESTIMATES Brad S. Karon, MD, PhD, is associate professor of laboratory medicine and pathology, and director of the Hospital Clinical Laboratories, point-of-care testing, and phlebotomy services at Mayo Clinic in

Rochester, MN.

CONSIDERING OUT-OF-STATE LAB SERVICES Q Our lab is considering expanding our service area to one or more adjacent states. Are there any particular payment or regulatory issues that we should consider? A This question raises many issues. Regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) provide clinical laboratory testing standards that apply throughout the country. STRATEGIES FOR AVOIDING AMPLICON CONTAMINATION IN THESEE MORE ON

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THE IMPORTANCE OF IMPLEMENTING A QUALITY MANAGEMENT SYSTEM Laboratory quality can be defined as accuracy, reliability, and timeliness of reported test results. To be useful, laboratory results must be as accurate as possible, all aspects of the laboratory operations must be reliable, and reporting must be timely. HOME | MEDICAL LABORATORY OBSERVERCONTINUING EDUCATIONWEBINARSWHITEPAPERSEVENTSCAREERSADVERTISE Articles, news, products, blogs and videos from Medical Laboratory

Observer.

MAGAZINES | MEDICAL LABORATORY OBSERVERINFORMATION TECHNOLOGYMANAGEMENTDISEASEEVENTSCONTACT USWHITEPAPERS mlo-online.com features online exclusive content as well as feature articles and stories from our print publications. Access digital editions and recent issues for our magazine here. AMA ANNOUNCES UPDATE TO COVID-19 VACCINE CPT CODES The American Medical Association (AMA) announced that the Current Procedural Terminology (CPT) code set has been updated by the CPT Editorial Panel to include vaccine and administration codes that are unique to the COVID-19 vaccine candidate under development by Novavax. MLO’S 2021 ANNUAL SALARY SURVEY OF LABORATORY According to the results of Medical Laboratory Observer’s 2021 annual salary survey of laboratory professionals, average salary has increased and job security remains high, but the COVID-19 pandemic has exacerbated the profession’s staff shortages, with 80 percent of respondents noting shortages having a “moderate to large impact” on operational efficiency. LEGAL LIABILITY IN URINE DRUG TESTING: COULD YOUR LAB BESEE MORE ON

MLO-ONLINE.COM

PERKINELMER TO ACQUIRE IMMUNODIAGNOSTIC SYSTEMS PerkinElmer and Immunodiagnostic Systems have reached an agreement on the terms of an all-cash offer in which PerkinElmer will acquire IDS for approximately $155 million. REVIEW OF PLATELET ESTIMATES Brad S. Karon, MD, PhD, is associate professor of laboratory medicine and pathology, and director of the Hospital Clinical Laboratories, point-of-care testing, and phlebotomy services at Mayo Clinic in

Rochester, MN.

CONSIDERING OUT-OF-STATE LAB SERVICES Q Our lab is considering expanding our service area to one or more adjacent states. Are there any particular payment or regulatory issues that we should consider? A This question raises many issues. Regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) provide clinical laboratory testing standards that apply throughout the country. STRATEGIES FOR AVOIDING AMPLICON CONTAMINATION IN THESEE MORE ON

MLO-ONLINE.COM

THE IMPORTANCE OF IMPLEMENTING A QUALITY MANAGEMENT SYSTEM Laboratory quality can be defined as accuracy, reliability, and timeliness of reported test results. To be useful, laboratory results must be as accurate as possible, all aspects of the laboratory operations must be reliable, and reporting must be timely. MAGAZINES | MEDICAL LABORATORY OBSERVER mlo-online.com features online exclusive content as well as feature articles and stories from our print publications. Access digital editions and recent issues for our magazine here. HOW RACE AND POVERTY WAS IMPACTED BY COVID-19 A new analysis by researchers at Massachusetts General Hospital (MGH) offers a novel perspective on the disproportionate impact that COVID-19 has had on people of color, low-income populations, and other structurally disadvantaged groups. NEW POLIO ERADICATION STRATEGY ANNOUNCED The Global Polio Eradication Initiative (GPEI) will launch the Polio Eradication Strategy 2022-2026, which is designed to overcome the remaining challenges to ending polio, including setbacks caused by COVID-19, according to the World Health Organization. STUDY ON SMOKING DURING THE PANDEMIC Last year, people who smoked had a variety of responses to the COVID-19 pandemic, with some increasing their smoking to help them cope and others quitting to potentially lessen their vulnerability to

COVID-19.

CMS INCREASES PROVIDER PAYMENT FOR IN-HOME COVID-19 The Centers for Medicare & Medicaid Services (CMS) plans to pay an additional $35 per dose to providers for administering in-home COVID-19 vaccinations to Medicare beneficiaries who have difficulty leaving their homes or are hard-to-reach. U.S. PROCURES MERCK’S INVESTIGATIONAL ANTIVIRAL MEDICINE The U.S. government will procure approximately 1.7 million courses of an investigational antiviral treatment, molnupiravir (MK-4482), for COVID-19 from Merck, pending emergency use authorization (EUA) or approval from the U.S. Food and Drug Administration (FDA), according to a news release from the Department of Health and Human Services

(HHS).

WHO HANDBOOK HELPS WITH FOODBORNE DISEASES Hospital laboratories are using high-throughput antigen tests for fast, accurate in-house COVID-19 testing. Used on existing VITROS Systems, these tests provide results faster than PCR tests, delivering them within hours, not days. VACCINE LIKELY DOES NOT INCREASE RISK OF HEARING LOSS In a new study, Johns Hopkins Medicine researchers have tried to address recent reports that sudden sensorineural hearing loss — a condition that occurs as a result of damage to the inner ear — has been suspected of being a potential side effect of vaccination against SARS-CoV-2, the virus that causes COVID-19. FDA APPROVES PFIZER’S PNEUMOCOCCAL 20 VACCINE Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in STUDYING KIDNEY BIOMARKERS IN SPACE High-throughput antigen tests deliver accurate results within hours, allowing labs to play a role in combatting viral spread. Tests work on existing VITROS® Systems and are already helping hospitals expand

community testing.

AMA ANNOUNCES UPDATE TO COVID-19 VACCINE CPT CODES The Novavax COVID-19 vaccine has been assigned the Category I CPT code of 91304.In addition to the new vaccine-specific product CPT code, the Novavax COVID-19 vaccine has been issued two specific codes for administering the two-dose vaccine: code of 0041A for the first dose and 0042A for the second dose. Visit the AMA for more news. MLO’S 2021 ANNUAL SALARY SURVEY OF LABORATORY Average salary on the rise. Average compensation of laboratory professionals across the board rose $4,044, from $93,844 in 2020 to $97,888 in 2021. While men still report the highest average salary (at $103,233), the average salary for female lab professionals grew slightly more than that of their male colleagues from 2020 to 2021,

with females

LABORATORY ACCESS:

Laboratory access: when to withdraw the welcome mat. Q Currently, there is a stream of visitors in the work area of our laboratory, including couriers from reference labs, sales reps, family members, employees just visiting from other departments, union representatives, and so on. Is there some statute or rule that limits the number and type of visitors or that prohibits certain visits? ANSWERING YOUR QUESTIONS The presence of lipemia is generally determined by directly observing the patient’s plasma post centrifugation and/or questioning the MCHC value (>36.5). Review of the patient’s peripheral blood smear will also show fuzzy red cell outlines. To correct for the presence of lipemia, a microhematocrit is performed and a blank from the patient PERKINELMER TO ACQUIRE IMMUNODIAGNOSTIC SYSTEMS PerkinElmer to acquire Immunodiagnostic Systems. PerkinElmer and Immunodiagnostic Systems have reached an agreement on the terms of an all-cash offer in which PerkinElmer will acquire IDS for approximately $155 million. Headquartered in Boldon, the United Kingdom, IDS is an in-vitro diagnostic solution provider that develops, manufactures, and REVIEW OF PLATELET ESTIMATES The total platelet count per 1,000 RBCs is then multiplied by the RBC count and divided by 1,000 to convert units from 10 12 /L to10 9 /L. Therefore, with a total of 70 PLTs per 1,000 RBCs and a RBC count of 4.10 x 10 12 /L, the calculations would be: RBC count/1,000 = 4.10 x 109/L. PLTs/1,000 RBCs = 70. Indirect PLT: 70 x 4.10 = 287 x 109/L. CMS ISSUES FINAL GUIDELINES ON COVERING TESTS FOR The Centers for Medicare & Medicaid Services (CMS) finalized guidelines outlining when it will cover blood-based biomarkers tests for colorectal cancer screening, but it did not approve coverage for an available test, according to a final decision memo. CYTOKINES: UTILITY AND LABORATORY MEASUREMENT Cytokines: utility and laboratory measurement. MLO Staff. Dec 1st, 2011. Cytokines are soluble proteins that act as chemical messengers in the immune response, and play an important role for communication with cells in other systems and in cell growth, differentiation, and hematopoisis. New advances have shown that there may be wide LEGAL LIABILITY IN URINE DRUG TESTING: COULD YOUR LAB BESEE MORE ON

MLO-ONLINE.COM

WES VS WGS: WHY THE EXOME ISN’T THE WHOLE STORY (AND In this month’s installment we’re going to revisit in a bit more depth a topic that’s been touched on in this space before—that is, the differences between a whole genome sequence (WGS) and a whole exome sequence (WES). AMA ANNOUNCES UPDATE TO COVID-19 VACCINE CPT CODES The Novavax COVID-19 vaccine has been assigned the Category I CPT code of 91304.In addition to the new vaccine-specific product CPT code, the Novavax COVID-19 vaccine has been issued two specific codes for administering the two-dose vaccine: code of 0041A for the first dose and 0042A for the second dose. Visit the AMA for more news. MLO’S 2021 ANNUAL SALARY SURVEY OF LABORATORY Average salary on the rise. Average compensation of laboratory professionals across the board rose $4,044, from $93,844 in 2020 to $97,888 in 2021. While men still report the highest average salary (at $103,233), the average salary for female lab professionals grew slightly more than that of their male colleagues from 2020 to 2021,

with females

LABORATORY ACCESS:

Laboratory access: when to withdraw the welcome mat. Q Currently, there is a stream of visitors in the work area of our laboratory, including couriers from reference labs, sales reps, family members, employees just visiting from other departments, union representatives, and so on. Is there some statute or rule that limits the number and type of visitors or that prohibits certain visits? ANSWERING YOUR QUESTIONS The presence of lipemia is generally determined by directly observing the patient’s plasma post centrifugation and/or questioning the MCHC value (>36.5). Review of the patient’s peripheral blood smear will also show fuzzy red cell outlines. To correct for the presence of lipemia, a microhematocrit is performed and a blank from the patient PERKINELMER TO ACQUIRE IMMUNODIAGNOSTIC SYSTEMS PerkinElmer to acquire Immunodiagnostic Systems. PerkinElmer and Immunodiagnostic Systems have reached an agreement on the terms of an all-cash offer in which PerkinElmer will acquire IDS for approximately $155 million. Headquartered in Boldon, the United Kingdom, IDS is an in-vitro diagnostic solution provider that develops, manufactures, and REVIEW OF PLATELET ESTIMATES The total platelet count per 1,000 RBCs is then multiplied by the RBC count and divided by 1,000 to convert units from 10 12 /L to10 9 /L. Therefore, with a total of 70 PLTs per 1,000 RBCs and a RBC count of 4.10 x 10 12 /L, the calculations would be: RBC count/1,000 = 4.10 x 109/L. PLTs/1,000 RBCs = 70. Indirect PLT: 70 x 4.10 = 287 x 109/L. CMS ISSUES FINAL GUIDELINES ON COVERING TESTS FOR The Centers for Medicare & Medicaid Services (CMS) finalized guidelines outlining when it will cover blood-based biomarkers tests for colorectal cancer screening, but it did not approve coverage for an available test, according to a final decision memo. CYTOKINES: UTILITY AND LABORATORY MEASUREMENT Cytokines: utility and laboratory measurement. MLO Staff. Dec 1st, 2011. Cytokines are soluble proteins that act as chemical messengers in the immune response, and play an important role for communication with cells in other systems and in cell growth, differentiation, and hematopoisis. New advances have shown that there may be wide LEGAL LIABILITY IN URINE DRUG TESTING: COULD YOUR LAB BESEE MORE ON

MLO-ONLINE.COM

WES VS WGS: WHY THE EXOME ISN’T THE WHOLE STORY (AND In this month’s installment we’re going to revisit in a bit more depth a topic that’s been touched on in this space before—that is, the differences between a whole genome sequence (WGS) and a whole exome sequence (WES). STUDY ON SMOKING DURING THE PANDEMIC Last year, people who smoked had a variety of responses to the COVID-19 pandemic, with some increasing their smoking to help them cope and others quitting to potentially lessen their vulnerability to

COVID-19.

MRI OF ATHLETES WITH COVID DETECTS HEART INFLAMMATION A cardiac MRI of athletes who had COVID-19 is seven times more effective in detecting inflammation of the heart than symptom-based testing, suggests a study led by researchers at The Ohio State University Wexner Medical Center and College of Medicine with 12 other

Big Ten programs.

NEW HEART-FUNCTION MEASUREMENT IDENTIFIES HIGH-RISK A new physiological measurement of heart function developed at UVA Health could improve survival for people with heart failure by identifying high-risk patients who require tailored treatments, a new

study suggests.

WHO HANDBOOK HELPS WITH FOODBORNE DISEASES Hospital laboratories are using high-throughput antigen tests for fast, accurate in-house COVID-19 testing. Used on existing VITROS Systems, these tests provide results faster than PCR tests, delivering them within hours, not days. STUDYING KIDNEY BIOMARKERS IN SPACE High-throughput antigen tests deliver accurate results within hours, allowing labs to play a role in combatting viral spread. Tests work on existing VITROS® Systems and are already helping hospitals expand

community testing.

ORASURE RECEIVES EUA FOR RAPID COVID-19 TESTS OraSure Technologies said it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the company’s COVID-19 rapid antigen tests. VACCINE LIKELY DOES NOT INCREASE RISK OF HEARING LOSS In a new study, Johns Hopkins Medicine researchers have tried to address recent reports that sudden sensorineural hearing loss — a condition that occurs as a result of damage to the inner ear — has been suspected of being a potential side effect of vaccination against SARS-CoV-2, the virus that causes COVID-19. HHS TO SHORE UP DOMESTIC PRODUCTION OF MEDICATIONS AND Under the Defense Production Act, the Department of Health and Human Services (HHS) will establish a public-private consortium for advanced domestic manufacturing of essential medicines and active pharmaceutical ingredients, or APIs. AN EFFORT TO REDUCE RADIATION IN IMAGING An effort by the Michigan Radiation Oncology Quality Consortium reduced excessive radiation treatments for bone metastases by 80% at healthcare centers across the state, according to findings published in Practical Radiation Oncology as reported in a news release from

Michigan Medicine.

ANSWERING YOUR QUESTIONS Sarewitz' comment. In summary, 1) critical values should be set. jointly between clinicians and the lab; 2) exceptions to calling based. on clinical conditions may be defined, but this should be done as part. of the joint process, and it should be part of a well defined

policy; 3)

AMA ANNOUNCES UPDATE TO COVID-19 VACCINE CPT CODES The Novavax COVID-19 vaccine has been assigned the Category I CPT code of 91304.In addition to the new vaccine-specific product CPT code, the Novavax COVID-19 vaccine has been issued two specific codes for administering the two-dose vaccine: code of 0041A for the first dose and 0042A for the second dose. Visit the AMA for more news. MLO’S 2021 ANNUAL SALARY SURVEY OF LABORATORY Average salary on the rise. Average compensation of laboratory professionals across the board rose $4,044, from $93,844 in 2020 to $97,888 in 2021. While men still report the highest average salary (at $103,233), the average salary for female lab professionals grew slightly more than that of their male colleagues from 2020 to 2021,

with females

LABORATORY ACCESS:

Laboratory access: when to withdraw the welcome mat. Q Currently, there is a stream of visitors in the work area of our laboratory, including couriers from reference labs, sales reps, family members, employees just visiting from other departments, union representatives, and so on. Is there some statute or rule that limits the number and type of visitors or that prohibits certain visits? ANSWERING YOUR QUESTIONS The presence of lipemia is generally determined by directly observing the patient’s plasma post centrifugation and/or questioning the MCHC value (>36.5). Review of the patient’s peripheral blood smear will also show fuzzy red cell outlines. To correct for the presence of lipemia, a microhematocrit is performed and a blank from the patient PERKINELMER TO ACQUIRE IMMUNODIAGNOSTIC SYSTEMS PerkinElmer to acquire Immunodiagnostic Systems. PerkinElmer and Immunodiagnostic Systems have reached an agreement on the terms of an all-cash offer in which PerkinElmer will acquire IDS for approximately $155 million. Headquartered in Boldon, the United Kingdom, IDS is an in-vitro diagnostic solution provider that develops, manufactures, and REVIEW OF PLATELET ESTIMATES The total platelet count per 1,000 RBCs is then multiplied by the RBC count and divided by 1,000 to convert units from 10 12 /L to10 9 /L. Therefore, with a total of 70 PLTs per 1,000 RBCs and a RBC count of 4.10 x 10 12 /L, the calculations would be: RBC count/1,000 = 4.10 x 109/L. PLTs/1,000 RBCs = 70. Indirect PLT: 70 x 4.10 = 287 x 109/L. CMS ISSUES FINAL GUIDELINES ON COVERING TESTS FOR The Centers for Medicare & Medicaid Services (CMS) finalized guidelines outlining when it will cover blood-based biomarkers tests for colorectal cancer screening, but it did not approve coverage for an available test, according to a final decision memo. CYTOKINES: UTILITY AND LABORATORY MEASUREMENT Cytokines: utility and laboratory measurement. MLO Staff. Dec 1st, 2011. Cytokines are soluble proteins that act as chemical messengers in the immune response, and play an important role for communication with cells in other systems and in cell growth, differentiation, and hematopoisis. New advances have shown that there may be wide LEGAL LIABILITY IN URINE DRUG TESTING: COULD YOUR LAB BESEE MORE ON

MLO-ONLINE.COM

WES VS WGS: WHY THE EXOME ISN’T THE WHOLE STORY (AND In this month’s installment we’re going to revisit in a bit more depth a topic that’s been touched on in this space before—that is, the differences between a whole genome sequence (WGS) and a whole exome sequence (WES). AMA ANNOUNCES UPDATE TO COVID-19 VACCINE CPT CODES The Novavax COVID-19 vaccine has been assigned the Category I CPT code of 91304.In addition to the new vaccine-specific product CPT code, the Novavax COVID-19 vaccine has been issued two specific codes for administering the two-dose vaccine: code of 0041A for the first dose and 0042A for the second dose. Visit the AMA for more news. MLO’S 2021 ANNUAL SALARY SURVEY OF LABORATORY Average salary on the rise. Average compensation of laboratory professionals across the board rose $4,044, from $93,844 in 2020 to $97,888 in 2021. While men still report the highest average salary (at $103,233), the average salary for female lab professionals grew slightly more than that of their male colleagues from 2020 to 2021,

with females

LABORATORY ACCESS:

Laboratory access: when to withdraw the welcome mat. Q Currently, there is a stream of visitors in the work area of our laboratory, including couriers from reference labs, sales reps, family members, employees just visiting from other departments, union representatives, and so on. Is there some statute or rule that limits the number and type of visitors or that prohibits certain visits? ANSWERING YOUR QUESTIONS The presence of lipemia is generally determined by directly observing the patient’s plasma post centrifugation and/or questioning the MCHC value (>36.5). Review of the patient’s peripheral blood smear will also show fuzzy red cell outlines. To correct for the presence of lipemia, a microhematocrit is performed and a blank from the patient PERKINELMER TO ACQUIRE IMMUNODIAGNOSTIC SYSTEMS PerkinElmer to acquire Immunodiagnostic Systems. PerkinElmer and Immunodiagnostic Systems have reached an agreement on the terms of an all-cash offer in which PerkinElmer will acquire IDS for approximately $155 million. Headquartered in Boldon, the United Kingdom, IDS is an in-vitro diagnostic solution provider that develops, manufactures, and REVIEW OF PLATELET ESTIMATES The total platelet count per 1,000 RBCs is then multiplied by the RBC count and divided by 1,000 to convert units from 10 12 /L to10 9 /L. Therefore, with a total of 70 PLTs per 1,000 RBCs and a RBC count of 4.10 x 10 12 /L, the calculations would be: RBC count/1,000 = 4.10 x 109/L. PLTs/1,000 RBCs = 70. Indirect PLT: 70 x 4.10 = 287 x 109/L. CMS ISSUES FINAL GUIDELINES ON COVERING TESTS FOR The Centers for Medicare & Medicaid Services (CMS) finalized guidelines outlining when it will cover blood-based biomarkers tests for colorectal cancer screening, but it did not approve coverage for an available test, according to a final decision memo. CYTOKINES: UTILITY AND LABORATORY MEASUREMENT Cytokines: utility and laboratory measurement. MLO Staff. Dec 1st, 2011. Cytokines are soluble proteins that act as chemical messengers in the immune response, and play an important role for communication with cells in other systems and in cell growth, differentiation, and hematopoisis. New advances have shown that there may be wide LEGAL LIABILITY IN URINE DRUG TESTING: COULD YOUR LAB BESEE MORE ON

MLO-ONLINE.COM

WES VS WGS: WHY THE EXOME ISN’T THE WHOLE STORY (AND In this month’s installment we’re going to revisit in a bit more depth a topic that’s been touched on in this space before—that is, the differences between a whole genome sequence (WGS) and a whole exome sequence (WES). LINGERING COVID-19 SYMPTOMS PERSIST MONTHS AFTER BEING ILL A wide variety of symptoms persisted in more than 70% of COVID-19 patients months after recovering from the initial phases of disease,

according to a

MRI OF ATHLETES WITH COVID DETECTS HEART INFLAMMATION A cardiac MRI of athletes who had COVID-19 is seven times more effective in detecting inflammation of the heart than symptom-based testing, suggests a study led by researchers at The Ohio State University Wexner Medical Center and College of Medicine with 12 other

Big Ten programs.

WHO HANDBOOK HELPS WITH FOODBORNE DISEASES Hospital laboratories are using high-throughput antigen tests for fast, accurate in-house COVID-19 testing. Used on existing VITROS Systems, these tests provide results faster than PCR tests, delivering them within hours, not days. COVID-19 VACCINE MAY NOT BE ENOUGH PROTECTION FOR THOSE Researchers at Johns Hopkins Medicine have lower-than-normal immune response to the messenger RNA (mRNA) COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases (RMDs), conditions that often call for treatment with medications that suppress the immune system, according to a news release. THERMO FISHER SCIENTIFIC LAUNCHES FLOW CYTOMETER WITH Thermo Fisher Scientific announced the launch of an imaging-enhanced flow cytometer that combines acoustic focusing flow cytometry technology with a high-speed camera. VACCINE NOT INCREASING RISK OF HEARING LOSS In a new study, Johns Hopkins Medicine researchers have tried to address recent reports that sudden sensorineural hearing loss — a condition that occurs as a result of damage to the inner ear — has been suspected of being a potential side effect of vaccination against SARS-CoV-2, the virus that causes COVID-19. THE FDA APPROVES FIRST ALZHEIMER’S DRUG SINCE 2003 The U.S. Food and Drug Administration (FDA) approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. ANTISEIZURE DRUGS PREGNANCY NOT LINKED TO COGNITIVE New findings published in JAMA Neurology suggest there is no difference in cognitive outcomes at 2 years old among children of healthy women and children of women with epilepsy who took antiseizure medication during pregnancy, according to a news release from the National Institutes of Health (NIH).. The findings are part of the large research project Maternal Outcomes and ANSWERING YOUR QUESTIONS Sarewitz' comment. In summary, 1) critical values should be set. jointly between clinicians and the lab; 2) exceptions to calling based. on clinical conditions may be defined, but this should be done as part. of the joint process, and it should be part of a well defined

policy; 3)

THE PROS AND CONS OF POINT-OF-CARE TESTING VS LABORATORY There are clear pros and cons to POCT versus laboratory testing. There are situations where POCT can provide a definite advantage to the treating clinician, have minimal risk, better cost savings, and provide a quality healthcare experience for the patient. However, core laboratory testing is more advanced, follows the process and science

for

AMA ANNOUNCES UPDATE TO COVID-19 VACCINE CPT CODES The Novavax COVID-19 vaccine has been assigned the Category I CPT code of 91304.In addition to the new vaccine-specific product CPT code, the Novavax COVID-19 vaccine has been issued two specific codes for administering the two-dose vaccine: code of 0041A for the first dose and 0042A for the second dose. Visit the AMA for more news. MLO’S 2021 ANNUAL SALARY SURVEY OF LABORATORY Average salary on the rise. Average compensation of laboratory professionals across the board rose $4,044, from $93,844 in 2020 to $97,888 in 2021. While men still report the highest average salary (at $103,233), the average salary for female lab professionals grew slightly more than that of their male colleagues from 2020 to 2021,

with females

LABORATORY ACCESS:

Laboratory access: when to withdraw the welcome mat. Q Currently, there is a stream of visitors in the work area of our laboratory, including couriers from reference labs, sales reps, family members, employees just visiting from other departments, union representatives, and so on. Is there some statute or rule that limits the number and type of visitors or that prohibits certain visits? ANSWERING YOUR QUESTIONS The presence of lipemia is generally determined by directly observing the patient’s plasma post centrifugation and/or questioning the MCHC value (>36.5). Review of the patient’s peripheral blood smear will also show fuzzy red cell outlines. To correct for the presence of lipemia, a microhematocrit is performed and a blank from the patient PERKINELMER TO ACQUIRE IMMUNODIAGNOSTIC SYSTEMS PerkinElmer to acquire Immunodiagnostic Systems. PerkinElmer and Immunodiagnostic Systems have reached an agreement on the terms of an all-cash offer in which PerkinElmer will acquire IDS for approximately $155 million. Headquartered in Boldon, the United Kingdom, IDS is an in-vitro diagnostic solution provider that develops, manufactures, and REVIEW OF PLATELET ESTIMATES The total platelet count per 1,000 RBCs is then multiplied by the RBC count and divided by 1,000 to convert units from 10 12 /L to10 9 /L. Therefore, with a total of 70 PLTs per 1,000 RBCs and a RBC count of 4.10 x 10 12 /L, the calculations would be: RBC count/1,000 = 4.10 x 109/L. PLTs/1,000 RBCs = 70. Indirect PLT: 70 x 4.10 = 287 x 109/L. CMS ISSUES FINAL GUIDELINES ON COVERING TESTS FOR The Centers for Medicare & Medicaid Services (CMS) finalized guidelines outlining when it will cover blood-based biomarkers tests for colorectal cancer screening, but it did not approve coverage for an available test, according to a final decision memo. CYTOKINES: UTILITY AND LABORATORY MEASUREMENT Cytokines: utility and laboratory measurement. MLO Staff. Dec 1st, 2011. Cytokines are soluble proteins that act as chemical messengers in the immune response, and play an important role for communication with cells in other systems and in cell growth, differentiation, and hematopoisis. New advances have shown that there may be wide LEGAL LIABILITY IN URINE DRUG TESTING: COULD YOUR LAB BESEE MORE ON

MLO-ONLINE.COM

WES VS WGS: WHY THE EXOME ISN’T THE WHOLE STORY (AND In this month’s installment we’re going to revisit in a bit more depth a topic that’s been touched on in this space before—that is, the differences between a whole genome sequence (WGS) and a whole exome sequence (WES). AMA ANNOUNCES UPDATE TO COVID-19 VACCINE CPT CODES The Novavax COVID-19 vaccine has been assigned the Category I CPT code of 91304.In addition to the new vaccine-specific product CPT code, the Novavax COVID-19 vaccine has been issued two specific codes for administering the two-dose vaccine: code of 0041A for the first dose and 0042A for the second dose. Visit the AMA for more news. MLO’S 2021 ANNUAL SALARY SURVEY OF LABORATORY Average salary on the rise. Average compensation of laboratory professionals across the board rose $4,044, from $93,844 in 2020 to $97,888 in 2021. While men still report the highest average salary (at $103,233), the average salary for female lab professionals grew slightly more than that of their male colleagues from 2020 to 2021,

with females

LABORATORY ACCESS:

Laboratory access: when to withdraw the welcome mat. Q Currently, there is a stream of visitors in the work area of our laboratory, including couriers from reference labs, sales reps, family members, employees just visiting from other departments, union representatives, and so on. Is there some statute or rule that limits the number and type of visitors or that prohibits certain visits? ANSWERING YOUR QUESTIONS The presence of lipemia is generally determined by directly observing the patient’s plasma post centrifugation and/or questioning the MCHC value (>36.5). Review of the patient’s peripheral blood smear will also show fuzzy red cell outlines. To correct for the presence of lipemia, a microhematocrit is performed and a blank from the patient PERKINELMER TO ACQUIRE IMMUNODIAGNOSTIC SYSTEMS PerkinElmer to acquire Immunodiagnostic Systems. PerkinElmer and Immunodiagnostic Systems have reached an agreement on the terms of an all-cash offer in which PerkinElmer will acquire IDS for approximately $155 million. Headquartered in Boldon, the United Kingdom, IDS is an in-vitro diagnostic solution provider that develops, manufactures, and REVIEW OF PLATELET ESTIMATES The total platelet count per 1,000 RBCs is then multiplied by the RBC count and divided by 1,000 to convert units from 10 12 /L to10 9 /L. Therefore, with a total of 70 PLTs per 1,000 RBCs and a RBC count of 4.10 x 10 12 /L, the calculations would be: RBC count/1,000 = 4.10 x 109/L. PLTs/1,000 RBCs = 70. Indirect PLT: 70 x 4.10 = 287 x 109/L. CMS ISSUES FINAL GUIDELINES ON COVERING TESTS FOR The Centers for Medicare & Medicaid Services (CMS) finalized guidelines outlining when it will cover blood-based biomarkers tests for colorectal cancer screening, but it did not approve coverage for an available test, according to a final decision memo. CYTOKINES: UTILITY AND LABORATORY MEASUREMENT Cytokines: utility and laboratory measurement. MLO Staff. Dec 1st, 2011. Cytokines are soluble proteins that act as chemical messengers in the immune response, and play an important role for communication with cells in other systems and in cell growth, differentiation, and hematopoisis. New advances have shown that there may be wide LEGAL LIABILITY IN URINE DRUG TESTING: COULD YOUR LAB BESEE MORE ON

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WES VS WGS: WHY THE EXOME ISN’T THE WHOLE STORY (AND In this month’s installment we’re going to revisit in a bit more depth a topic that’s been touched on in this space before—that is, the differences between a whole genome sequence (WGS) and a whole exome sequence (WES). LINGERING COVID-19 SYMPTOMS PERSIST MONTHS AFTER BEING ILL A wide variety of symptoms persisted in more than 70% of COVID-19 patients months after recovering from the initial phases of disease,

according to a

MRI OF ATHLETES WITH COVID DETECTS HEART INFLAMMATION A cardiac MRI of athletes who had COVID-19 is seven times more effective in detecting inflammation of the heart than symptom-based testing, suggests a study led by researchers at The Ohio State University Wexner Medical Center and College of Medicine with 12 other

Big Ten programs.

WHO HANDBOOK HELPS WITH FOODBORNE DISEASES Hospital laboratories are using high-throughput antigen tests for fast, accurate in-house COVID-19 testing. Used on existing VITROS Systems, these tests provide results faster than PCR tests, delivering them within hours, not days. COVID-19 VACCINE MAY NOT BE ENOUGH PROTECTION FOR THOSE Researchers at Johns Hopkins Medicine have lower-than-normal immune response to the messenger RNA (mRNA) COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases (RMDs), conditions that often call for treatment with medications that suppress the immune system, according to a news release. THERMO FISHER SCIENTIFIC LAUNCHES FLOW CYTOMETER WITH Thermo Fisher Scientific announced the launch of an imaging-enhanced flow cytometer that combines acoustic focusing flow cytometry technology with a high-speed camera. VACCINE NOT INCREASING RISK OF HEARING LOSS In a new study, Johns Hopkins Medicine researchers have tried to address recent reports that sudden sensorineural hearing loss — a condition that occurs as a result of damage to the inner ear — has been suspected of being a potential side effect of vaccination against SARS-CoV-2, the virus that causes COVID-19. THE FDA APPROVES FIRST ALZHEIMER’S DRUG SINCE 2003 The U.S. Food and Drug Administration (FDA) approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. ANTISEIZURE DRUGS PREGNANCY NOT LINKED TO COGNITIVE New findings published in JAMA Neurology suggest there is no difference in cognitive outcomes at 2 years old among children of healthy women and children of women with epilepsy who took antiseizure medication during pregnancy, according to a news release from the National Institutes of Health (NIH).. The findings are part of the large research project Maternal Outcomes and ANSWERING YOUR QUESTIONS Sarewitz' comment. In summary, 1) critical values should be set. jointly between clinicians and the lab; 2) exceptions to calling based. on clinical conditions may be defined, but this should be done as part. of the joint process, and it should be part of a well defined

policy; 3)

THE PROS AND CONS OF POINT-OF-CARE TESTING VS LABORATORY There are clear pros and cons to POCT versus laboratory testing. There are situations where POCT can provide a definite advantage to the treating clinician, have minimal risk, better cost savings, and provide a quality healthcare experience for the patient. However, core laboratory testing is more advanced, follows the process and science

for

HOME | MEDICAL LABORATORY OBSERVERCONTINUING EDUCATIONWEBINARSWHITEPAPERSEVENTSCAREERSADVERTISE Articles, news, products, blogs and videos from Medical Laboratory

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CONTINUING EDUCATION TESTS June 2021. Article: How labs can help clinicians diagnose myocardial infarctions in women? Deadline: December 31, 2022 Contact Hours: 1.0 Click HERE to take the current test online (online test will be available June 1, 2021) Click HERE to download the current article and test pdf May 2021. Article: Common needs and interventions for COVID-19 and drug-resistant infections

LABORATORY ACCESS:

Laboratory access: when to withdraw the welcome mat. Q Currently, there is a stream of visitors in the work area of our laboratory, including couriers from reference labs, sales reps, family members, employees just visiting from other departments, union representatives, and so on. Is there some statute or rule that limits the number and type of visitors or that prohibits certain visits? THE PROS AND CONS OF POINT-OF-CARE TESTING VS LABORATORYSEE MORE ON

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CLIA REQUIREMENTS FOR PROFICIENCY TESTING: THE BASICS FOR Along with requirements for personnel qualifications and quality control testing, proficiency testing (PT) is one of the central safeguards of laboratory quality under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 1 and its regulations. 2 The CLIA regulations have often been compared to a three-legged stool, resting on requirements for personnel qualifications and two SAMPLE-TO-ANSWER INSTRUMENTS: PROS AND CONS PRE-ANALYTICAL ERRORS: THEIR IMPACT AND HOW TO MINIMIZE The clinical laboratory plays an increasingly important role in the patient-centered approach to the delivery of healthcare services. Physicians rely on accurate laboratory test results for proper disease diagnosis and for guiding therapy; it is estimated that more than 70% of clinical decisions are based on information derived from laboratory

test results. 1

REVIEW OF PLATELET ESTIMATES Brad S. Karon, MD, PhD, is associate professor of laboratory medicine and pathology, and director of the Hospital Clinical Laboratories, point-of-care testing, and phlebotomy services at Mayo Clinic in

Rochester, MN.

NEW LABORATORY EQUIPMENT PERFORMANCE QUALIFICATION Clinical and Laboratory Standards Institute (CLSI) has released a new guideline QMS23—General Laboratory Equipment Performance Qualification, Use, and Maintenance. LEGAL LIABILITY IN URINE DRUG TESTING: COULD YOUR LAB BESEE MORE ON MLO-ONLINE.COMBAD DRUG LAWSUITS HOME | MEDICAL LABORATORY OBSERVERCONTINUING EDUCATIONWEBINARSWHITEPAPERSEVENTSCAREERSADVERTISE Articles, news, products, blogs and videos from Medical Laboratory

Observer.

CONTINUING EDUCATION TESTS June 2021. Article: How labs can help clinicians diagnose myocardial infarctions in women? Deadline: December 31, 2022 Contact Hours: 1.0 Click HERE to take the current test online (online test will be available June 1, 2021) Click HERE to download the current article and test pdf May 2021. Article: Common needs and interventions for COVID-19 and drug-resistant infections

LABORATORY ACCESS:

Laboratory access: when to withdraw the welcome mat. Q Currently, there is a stream of visitors in the work area of our laboratory, including couriers from reference labs, sales reps, family members, employees just visiting from other departments, union representatives, and so on. Is there some statute or rule that limits the number and type of visitors or that prohibits certain visits? THE PROS AND CONS OF POINT-OF-CARE TESTING VS LABORATORYSEE MORE ON

MLO-ONLINE.COM

CLIA REQUIREMENTS FOR PROFICIENCY TESTING: THE BASICS FOR Along with requirements for personnel qualifications and quality control testing, proficiency testing (PT) is one of the central safeguards of laboratory quality under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 1 and its regulations. 2 The CLIA regulations have often been compared to a three-legged stool, resting on requirements for personnel qualifications and two SAMPLE-TO-ANSWER INSTRUMENTS: PROS AND CONS PRE-ANALYTICAL ERRORS: THEIR IMPACT AND HOW TO MINIMIZE The clinical laboratory plays an increasingly important role in the patient-centered approach to the delivery of healthcare services. Physicians rely on accurate laboratory test results for proper disease diagnosis and for guiding therapy; it is estimated that more than 70% of clinical decisions are based on information derived from laboratory

test results. 1

REVIEW OF PLATELET ESTIMATES Brad S. Karon, MD, PhD, is associate professor of laboratory medicine and pathology, and director of the Hospital Clinical Laboratories, point-of-care testing, and phlebotomy services at Mayo Clinic in

Rochester, MN.

NEW LABORATORY EQUIPMENT PERFORMANCE QUALIFICATION Clinical and Laboratory Standards Institute (CLSI) has released a new guideline QMS23—General Laboratory Equipment Performance Qualification, Use, and Maintenance. LEGAL LIABILITY IN URINE DRUG TESTING: COULD YOUR LAB BESEE MORE ON MLO-ONLINE.COMBAD DRUG LAWSUITS CONTINUING EDUCATION TESTS June 2021. Article: How labs can help clinicians diagnose myocardial infarctions in women? Deadline: December 31, 2022 Contact Hours: 1.0 Click HERE to take the current test online (online test will be available June 1, 2021) Click HERE to download the current article and test pdf May 2021. Article: Common needs and interventions for COVID-19 and drug-resistant infections LINGERING COVID-19 SYMPTOMS PERSIST MONTHS AFTER BEING ILL A wide variety of symptoms persisted in more than 70% of COVID-19 patients months after recovering from the initial phases of disease,

according to a

MRI OF ATHLETES WITH COVID DETECTS HEART INFLAMMATION A cardiac MRI of athletes who had COVID-19 is seven times more effective in detecting inflammation of the heart than symptom-based testing, suggests a study led by researchers at The Ohio State University Wexner Medical Center and College of Medicine with 12 other

Big Ten programs.

AMA ANNOUNCES UPDATE TO COVID-19 VACCINE CPT CODES The American Medical Association (AMA) announced that the Current Procedural Terminology (CPT) code set has been updated by the CPT Editorial Panel to include vaccine and administration codes that are unique to the COVID-19 vaccine candidate under development by Novavax. CDC SAYS SOME ADOLESCENTS WITH COVID-19 REQUIRE ICU CARE Among adolescents hospitalized for COVID-19, nearly one third required admission to an intensive care unit, and 5% required invasive mechanical ventilation but no associated deaths occurred, according to the Centers for Disease Control and Prevention (CDC) in OVERDOSE DEATHS ROSE BY 42% IN 2020 Based on cases handled by emergency medical services, the number of people in the U.S. who died due to drug overdoses was 42% higher in 2020 than the average number of overdose deaths in 2018 and 2019, according to a news release from UCLA. VACCINE LIKELY DOES NOT INCREASE RISK OF HEARING LOSS In a new study, Johns Hopkins Medicine researchers have tried to address recent reports that sudden sensorineural hearing loss — a condition that occurs as a result of damage to the inner ear — has been suspected of being a potential side effect of vaccination against SARS-CoV-2, the virus that causes COVID-19. ANSWERING YOUR QUESTIONS Q. How does one correct a hemoglobin determination when a patient presents with grossly lipemic plasma/serum? A. Interference with routine hemoglobin determinations may be suspected when the MCH and/or MCHC appear unlikely and can occur when lipid levels are elevated

(lipemia).

ANALYSIS OF SINGLE TUMOR CELLS ADVANCES METASTATIC In a new article published in Clinical Cancer Research, Moffitt Cancer Center researchers reveal how different therapies impact the surrounding immune environment of metastatic melanoma tumors according to location and identify a rare population of immune cells that is associated with improved overall survival, according to a news release from the organization. LUNG PROTEIN ELEVATION MAY PREDICT COPD High-throughput antigen tests deliver accurate results within hours, allowing labs to play a role in combatting viral spread. Tests work on existing VITROS® Systems and are already helping hospitals expand

community testing.

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