Wednesday, March 31, 2021

Brain Scraper: Why Do Some COVID Tests Hurt So Much?

March 30, 2021– The one time I got checked for COVID-19, I end up in the emergency clinic– but not due to the fact that I evaluated positive. Throughout the test, as the specialist kept inching the swab deeper and deeper inside my nose, I felt a little bit of discomfort. Afterward, I left the center with a shrug, thinking it wasn’t so bad I didn’t presume it would activate the worst headache I have actually ever had. I’ve had migraines for several years, so I know from headaches. This felt exponentially even worse, like a scary vise. Hours later on, after over the counter pain medications didn’t even take the edge off, I let my other half call an ambulance.

I’m far from alone in having a COVID test with an unsightly after-effects. And at her second test, Lennerman’s nose bled.

Aside from headaches, teary eyes, and nosebleeds, some people have actually fainted. Others describe the test as sensation “like I was cleaned from behind my eyeball,” “ wild uncomfortable,” and as if it “ reached to the back of my skull and after that returned for more” Someone’s eye started jerking, and another said she believed she was being lobotomized

The Nasopharyngeal Swab

Hundreds of countless COVID tests have actually been performed in the U.S. over the in 2015. Tests utilizing the nasopharyngeal swab– the one that seems like it may scrape your brain— are considered the gold requirement.

” Think about the millions who have actually been swabbed– you hear about every one that has a bad experience,” says Andrew Lane, MD, director of the Johns Hopkins Sinus. “It’s extremely, extremely unusual.”

Those disappointments can originate from a number of problems, thanks to the variety of things involved. Individuals tolerate discomfort differently and have various perceptions of stimuli. And human anatomy varies widely– your nasal passages may be more comprehensive or narrower than the individual standing beside you, or you might have a deviated septum Another factor: the ability of the service technician doing the test. Because screening increase so quickly, you’ll discover a series of training and experience levels.

The premise of the test itself is another part of the problem. And your nasal cavity is surrounding to your eye and your brain,” Lane says.

To do the test, a technician inserts a flexible, soft-tipped, 6-inch swab into your nostril. They’ll direct it to the back of your nose until it reaches the nasopharynx– the location where your nasal cavities satisfy your throat– and swirl it gently. They might leave it there for a few seconds to collect secretions. If the very first nostril does not provide adequate, they might repeat the process in the other nostril.

Describing Those Responses

The challenge, according to Lane, is that no 2 noses are the very same.

The mucous membrane that lines your nose has a great deal of nerve endings. “In general, the body’s beautiful tolerant the very first couple centimeters– as far as you can stick your finger in. Beyond that, the mucous membrane reacts to being touched.” Lane says.

That triggers involuntary, hard-wired reflexes. Depending on how strongly your body responds, the result can be discomfort, teary eyes, discomfort, and other responses. “Some people get gagging, coughing, sneezing— it’s all part of the very same reflex,” he says. For individuals who are more susceptible to get headaches, it can set off a whopper.

As for nosebleeds, that membrane (called the mucosa) is delicate and has lots of blood vessels, states Philip Chen, MD, an associate professor of otolaryngology– head and neck surgery at the University of Texas Long School of Medicine.

Fainting has an equally straightforward description: “It’s what’s called a vasovagal event. This can happen whenever the body has an extremely strong response to a scenario such as psychological distress or discomfort,” states Chen. “For some individuals, the stress and anxiety of having the treatment or the actual discomfort can lead to fainting

Scraping the Brain?

Although some state the test feels like having your brain tickled or stabbed, the swab can’t really come up to your grey matter.

” There are 3 layers of protection in the nose. There’s the mucosal lining, which covers the inside of the nose. There’s the olfactory epithelium (associated with sense of smell). The within, the dura mater, which indicates ‘tough mom,’ is a hard lining of skin around the brain. It’s tough to penetrate through (it) without something sharp,” Shawn Nasseri, MD, an ear, nose, and throat cosmetic surgeon in Los Angeles, told USA Today

In an extremely small number of cases worldwide, testing has led to dripping cerebrospinal fluid A minimum of among those was discovered to be due to a previously unidentified birth defect. “I suspect individuals who have this take place had an irregularity, a protrusion of brain tissue through a hole in the bone,” states Lane. The swab itself is flexible, so it’ll bend before entering bone.

” It’s such a low danger, I wouldn’t be frightened,” he says. “Your risk of having COVID and not knowing is much greater.”

There is one group that might be at a higher danger for this kind of trouble: “People who have actually had substantial sinus surgical treatment ought to not be tested with nasopharyngeal swab,” states Chen.

Tips for a Pain-Free Swab

Because anatomy and pain tolerance vary, there’s no chance of knowing if you’re likely to have a bad experience. These tips might minimize your pain:

  • If you’ve got a stuffy nose, try a spray decongestant like Afrin, Lane suggests. That can assist clear a path and make it less likely that the swab will run into anything on its way to your nasopharynx. Lie down and put one drop in each nostril, 30-60 minutes before the test.
  • Position your head as directed, so they can position the swab at the correct angle. “Wherever they tell you to put your head, put your head in that area and keep it there,” says Lane.

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The Art of Phlebotomy: Part 1

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This video is made for LCCC’s Phlebotomy program.

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Phlebotomy Technician (Donor)

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Brain Scraper: Why Do Some COVID Tests Hurt A Lot?

March 30, 2021– The one time I got checked for COVID-19, I wound up in the emergency space– but not since I checked positive. I didn’t presume it would activate the worst headache I have actually ever had. I have actually had migraines for years, so I understand from headaches.

I’m far from alone in having a COVID test with an awful consequences. And at her second test, Lennerman’s nose bled.

Aside from headaches, teary eyes, and nosebleeds, some people have passed out. One person’s eye started twitching, and another said she thought she was being lobotomized

The Nasopharyngeal Swab

Numerous countless COVID tests have actually been performed in the U.S. over the in 2015. Tests using the nasopharyngeal swab– the one that feels like it might scrape your brain— are considered the gold requirement.

” Believe about the millions who’ve been swabbed– you hear about every one that has a bad experience,” states Andrew Lane, MD, director of the Johns Hopkins Sinus. “It’s extremely, extremely unusual.”

Those disappointments can originate from several problems, thanks to the variety of things involved. Individuals tolerate pain in a different way and have various understandings of stimuli. And human anatomy varies extensively– your nasal passages might be broader or narrower than the individual standing beside you, or you may have a deviated septum Another element: the skill of the service technician doing the test. Because screening increase so rapidly, you’ll discover a variety of training and experience levels.

The premise of the test itself is another part of the problem. “The body doesn’t like foreign items going into the nose. It’s an open course from the outside world that goes straight to your windpipe and your lungs. And your nasal cavity is surrounding to your eye and your brain,” Lane states. “That’s a high-priority territory to protect.”

To do the test, a specialist inserts a versatile, soft-tipped, 6-inch swab into your nostril.

Discussing Those Responses

The difficulty, according to Lane, is that no two noses are the same. “The goal with the swab need to be to get to the nasopharynx without striking anything along the method,” he states. “Unfortunately, the geometry of the nasal passages is various from person to person.”

The mucous membrane that lines your nose has a lot of nerve endings. “In basic, the body’s pretty tolerant the very first couple centimeters– as far as you can stick your finger in. Beyond that, the mucous membrane reacts to being touched.” Lane says.

That triggers involuntary, hard-wired reflexes. Depending on how strongly your body responds, the result can be discomfort, teary eyes, discomfort, and other responses. “Some individuals get gagging, coughing, sneezing— it’s all part of the very same reflex,” he states. For individuals who are more vulnerable to get headaches, it can set off a whopper.

As for nosebleeds, that membrane (called the mucosa) is fragile and has lots of blood vessels, states Philip Chen, MD, an associate teacher of otolaryngology– head and neck surgery at the University of Texas Long School of Medication.

Fainting has a similarly simple description: “It’s what’s called a vasovagal event. This can take place whenever the body has an extremely strong action to a situation such as psychological distress or pain,” says Chen. “For some people, the stress and anxiety of having the treatment or the actual pain can lead to fainting

Scraping the Brain?

Although some say the test seems like having your brain tickled or stabbed, the swab can’t in fact get near your grey matter.

” There are 3 layers of protection in the nose. There’s the mucosal lining, which covers the within the nose. There’s the olfactory epithelium (involved in sense of odor). The inside, the dura mater, which suggests ‘difficult mother,’ is a difficult lining of skin around the brain. It’s tough to permeate through (it) without something sharp,” Shawn Nasseri, MD, an ear, nose, and throat surgeon in Los Angeles, told USA Today

In a really little number of cases around the world, screening has led to leaking cerebrospinal fluid

” It’s such a low threat, I wouldn’t be frightened,” he states. “Your danger of having COVID and not knowing is much greater.”

There is one group that may be at a greater risk for this type of trouble: “Individuals who have had extensive sinus surgical treatment need to not be checked with nasopharyngeal swab,” says Chen. He’s the lead author of a research study that looked at the need for alerting such clients. That kind of surgery frequently involves getting rid of a bone in between the nasal cavity and the base of the skull, which may allow the swab to get through.

Tips for a Pain-Free Swab

Because anatomy and discomfort tolerance differ, there’s no other way of understanding if you’re likely to have a disappointment. However these tips might decrease your pain:

  • If you’ve got a stuffy nose, try a spray decongestant like Afrin, Lane recommends. Lie down and put one drop in each nostril, 30-60 minutes prior to the test.
  • Pay attention to the service technician’s instructions. Position your head as directed, so they can position the swab at the proper angle. And once they begin, don’t move! “Wherever they inform you to put your head, put your head because spot and keep it there,” states Lane.

Learn More

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Phlebotomy Accreditation Florida|FL Phlebotomist Training

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WHO Report into COVID Pandemic Origins Zeroes in on Animal Markets, Not Labs

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initially released on March 30 2021.

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PHLEBOTOMY TECH II/COURIER

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Medical Service Technician - Phlebotomy

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'I Can Breathe Again': Older Grownups Start to Check Liberty After Covid Vaccinations

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With a mix of relief and caution, older grownups totally vaccinated against covid-19 are leaving into the world and resuming activities postponed during the pandemic.

Many are making strategies to see adult children and hug grandchildren they have not checked out for months– or longer. Others are getting together with good friends inside your home, for the first time in a long period of time.

People are setting up medical visits that had been delayed and putting trips to locations far and wide on calendars. Easy things that felt risky pre-vaccination now feel possible: cuddling a next-door neighbor’s canine, going for a walk in the park, stopping at a regional hangout for a cup of coffee.

” I feel I can breathe again,” said Barry Dym, 78, of Lexington, Massachusetts, revealing a commonly shared sense of flexibility.

The rapid rollout of covid vaccines to people 65 and older makes this possible. As of Monday, nearly 49%of senior citizens in the U.S. had actually been fully immunized, while almost 73%had actually received one dosage of the Moderna or Pfizer-BioNTech vaccine. ( A third vaccine, from Johnson & Johnson, became available earlier this month and requires just one dosage.)

Current guidance from the Centers for Disease Control and Prevention recognizes the protection that vaccines offer. According to the CDC, individuals who are totally immunized can meet inside without masks, without sustaining considerable danger. Likewise, they can check out fairly safely with people who have not been immunized, so long as those individuals are healthy and events remain little.

Still, with coronavirus variants circulating and 55,000 new infections reported daily, the CDC continues to recommend precautions somewhere else, such as wearing masks, staying physically distant in public and refraining from air travel.

How are older grownups who’ve been completely immunized– a fortunate group, to be sure, offered the millions of senior citizens who’ve yet to get shots– balancing a desire to shed seclusion with a need to stay safe amid a pandemic that’s not yet over? I asked a number of individuals I’ve talked to previously about their strategies and their reflections on the challenging year we’ve been through.

Mardell Reed, 80, of Pasadena, California, told me she wasn’t sure she ‘d get the vaccine originally, since “I was concerned about the process going so quickly and drug companies possibly producing something that wasn’t up to par.” However she changed her mind “as soon as we all started speaking with real scientists rather than political leaders.”

Now, Reed attempts to inform individuals she knows who remain reluctant to get the shots.

Reed utilized to stroll in her area routinely prior to the pandemic however stopped when she ended up being scared of being around other individuals. Restoring that habit is a goal.

Among Reed’s other concerns in the months ahead: visiting with her daughter, grandchildren and great-grandchildren, and seeing her primary care physician, a dental professional, a neurologist who’s dealing with nerve damage and an optometrist. “I didn’t want to go to locations where people might be ill this in 2015; now, it’s time for me to capture up on all that,” she said.

Harry Hutson, 73, and his other half, Mikey, 70, invited two couples to their home in Baltimore, on different nights, after getting their second Moderna shots in February and waiting 2 weeks. “We’re going right into having safe dinners with individuals who’ve been immunized,” Hutson told me.

He feels a touch of remaining uncertainty.

Hutson has continued working as an executive coach throughout the pandemic and has recently been giving talks on wish to service groups, not-for-profit companies and churches. “What I inform people is ‘You’ll help yourself by assisting others.’ We’re all emerging from injury and recovery needs to be a cumulative, not an individual, endeavor.”

On an individual note, Hutson is going through an attic loaded with yearbooks, letters and photos, “curating my family’s history.” He intends to make an across-the-country journey with his other half later this year visiting his boy’s family in Madison, Wisconsin, his daughter’s family in Portland, Oregon, and his bro in Eugene, Oregon, in addition to a number of friends.

Marian Hollingsworth, 67, of La Mesa, California, invested last spring and summertime sequestered at house with her spouse, Ed, 72, who had stomach cancer, focused on keeping Ed safe from the coronavirus. His health problem progressed and, in early October, Ed passed away at house, where the couple’s four adult kids had actually collected to say bye-bye.

Considering That then, Hollingsworth’s child Morgan, 27, who lives in New York City, has actually remained with his mother, keeping her business.

The pandemic’s renewal in the fall and winter made getting used to Ed’s loss “much more of a difficulty,” Hollingsworth said, since she could not get together with friends or get hugs– a kind of contact she wished for. To this day, his clothing hang in the closet because the locations she ‘d like to send them aren’t accepting donations.

When Hollingsworth became fully vaccinated in early March, she stated, she felt for the first time that “my head was coming up above water.” She’s not sure, yet, how much she desires to go out and see individuals, she’s looking forward to simple enjoyments: petting the neighbor’s pet and going on “distanced walks” with a couple of buddies. “I’m going to beware until there’s more clarity about what’s actually safe,” she told me.

She’s preparing her very first such getaway because becoming completely immunized– capturing a program at her favorite bar, St. James Live, in Atlanta. (Clarence Smart)

Wilma Jenkins, 82, who lives in South Fulton, Georgia, has actually struggled with depression off and on for years– a difficulty she’s spoken about publicly in talks to older adults.

Although Jenkins explains herself as an “introvert,” she made certain she had routine social contact before the pandemic. Many days, she ‘d take herself out to lunch at local dining establishments, chatting with the wait staff and other routine clients.

One of Jenkins’ excellent loves is music– the blues and jazz. A few days after we spoke, she was preparing to return to her favorite bar, St. James Reside In Atlanta, to catch a show– her very first such outing because becoming fully immunized in mid-February.

” I’m not scared to return into the world, but I will continue to be masked and socially distanced and wash my hands,” she told me.

Jenkins strategies to start strolling outside again; go to restaurants, so long as they’re not too crowded; and resume check outs with her two daughters, both physicians, who reside in Atlanta and Washington, D.C. Her most enthusiastic goal: flying out to San Diego in late July for an event marking her grand son Jamal’s retirement from the Navy.

Barry Dym, who retired four years back from his full-time job, states, “One of the lessons of covid for me was I still require to feel helpful and I like assisting individuals. I recognized perhaps I ‘d drew back too far.” He’s broadening his coaching and mentoring practice to do more for others. (Francine Jacobs)

Barry Dym is haunted by an image that’s repeated frequently during the previous year: He’s on a moving sidewalk, unable to get off, being hurried to a destination he doesn’t want to reach: old age. The image is related to the pandemic and knee discomfort that has intensified, painfully, over the previous six months, making walking harder.

This previous year was a time of modification for Dym, who retired 4 years back from his work as a consultant to not-for-profit organizations.

So, Dym expanded his training and mentoring practice– an activity he plans to continue. “Whatever I can do to help make this world better, I’m not going to stop trying,” he said.

Outside of travel strategies with his other half, Franny– to the Florida Keys this spring, to the Berkshires in western Massachusetts in the summer, and possibly to Israel in the fall– Dym stated he finds himself “more curious than anything” about what lies ahead.

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COVID Monoclonal Antibodies: Do They Work in Dialysis?

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Monoclonal antibody bamlanivimab appeared to work for end-stage renal disease (ESRD) patients in early data from dialysis service providers, but there are lots of concerns that remain.

The very first 40 dialysis clients who got the antibody treatment at U.S. Kidney Care centers had a 7-day hospitalization rate of 15%compared to 57%among a randomly tested comparator group of 49 coronavirus-infected dialysis patients matched for age, gender, diabetes status, and race.

The 30- day hospitalization rate was 39%versus 65%for those patients dealt with from when the dialysis network initially started administering the drug January 5 through completion of February.

That represents almost the totality of their experience with the drug, stated Mary Dittrich, MD, primary medical officer of U.S. Kidney Care, who reported their information at an American Society of Nephrology webinar previously in March.

With falling case counts nationwide, only another 5 clients have actually been dosed given that, she informed MedPage Today “A tradeoff that I’m extremely happy to make is that our infections have actually gone down, so our administrations have actually gone down.”

Fresenius Healthcare The United States And Canada and DaVita Kidney Care have also been tracking their numbers and outcomes, with their larger client populations.

Throughout DaVita’s more than 220 infusions, no negative occasions were reported with the infusion or in the 1-hour observation duration after it, George Aronoff, MD, vice president in DaVita’s Scientific Affairs Office, informed MedPage Today

” Just about 9%of our patients who have actually gotten the infusion have needed hospitalization within 21 days following infusion,” he noted.

Fresenius reported similar outcomes: “Considering that using this antibody treatment in our dialysis centers in early January, our preliminary data recommends that less than 10%of patients who got the treatment were hospitalized within the first 28 days after treatment,” stated its primary medical officer, Jeffrey Hymes, MD.

Altogether, it appears that bamlanivimab– industrialized and offered by Eli Lilly– securely decreased progression of illness in the ESRD population, Dittrich stated. “It’s little numbers and it’s early, but provided the scarceness of any information in our population … that’s the data we’re delighted about.”

Few, if any, ESRD patients were included in those essential scientific trials, so some information is better than none, she noted.

” It has actually been gut-wrenching to be defenseless in this pandemic,” Dittrich stated. “To have any option both in terms of vaccines and these monoclonal antibodies is motivating.”

However, there are some huge warns with this observational data. So much so that her group decided not to publish, she stated.

Monoclonal antibodies need to be given as outpatient treatment after a favorable for COVID-19, however there are logistical problems, Dittrich noted.

A big part of dialysis patients are admitted not long after COVID-19 diagnosis, normally within 5 days. In U.S. Kidney’s information, the average time to bamlanivimab administration after diagnosis was 4 days.

” There is intrinsic bias,” she alerted. “It’s very possible that we picked for a particular group of patients to get bamlanivimab– those with milder illness, those who were going to stay outpatient for 4 days.”

Hymes noted that the early Fresenius data will likewise require more analysis to correct for possible standard distinctions in the characteristics of clients who did and didn’t get the antibody.

Another problem is that the information only included bamlanivimab monotherapy, whereas distribution of that drug has stopped due to lowered effectiveness against SARS-CoV-2 variants such as those recognized from California and New York City. Rather, the mix of bamlanivimab and etesevimab(likewise from Eli Lilly), and a two-antibody mixed drink developed by Regeneron Pharmaceuticals, are the ones being dispersed.

” I do stress over how the variations rising in frequency is going to impact the efficacy of this therapy, which’s something we’ll be viewing carefully,” Dittrich stated. “I do not know that we have the capability to genomically sequence all our patients, but we want baseline efficacy data out there, understanding that the variations may alter that data.”

Fresenius continues to advocate usage of monoclonal antibodies for proper clients, Hymes noted, with just recently upgraded clinical guidelines to highlight the availability of the combination antibody and the discontinuation of bamlanivimab monotherapy.

Monoclonal antibodies are still pertinent even as vaccination will be presenting to ESRD patients through dialysis clinics nationwide in the next couple of weeks, Dittrich said.

” With the variations and the nation opening back up, we fret that numbers are going to go back up,” she stated. “Particularly if these variations cause more severe illness, which there is some tip they do, this will be much more appropriate.”

Last Upgraded March 30, 2021

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This Phlebotomist Operates On Coffee, Turmoil and Cuss Words, A Swear Word Adult Coloring Book For Tension Relieving, Fun Swearing Pages With Animals Mandalas and Flowers Patterns, Amusing Christmas Gag Gift For Phlebotomist

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Eliminate Stress and anxiety and Life Stress, With This Utlimate Relaxing Swear word Grownup Coloring Book! About This Book: – Fun Swearing Coloring Pages for individuals who Cuss a lot – 42 Stunning illustrated Unwinding Styles – Patterns, animals, mandalas, and flowers to color – Big size 8,5″ x 11″ White Pages – Makes The best gift for Women, males, coworker and anybody you appreciate Click The cover To expose what’s within!

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'Get this huge kid a LOLLI!' Jim Acosta's pic-tweet effort at inspiring individuals to 'get the COVID shot' goes OH so really incorrect and LOL

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This is the most Jim Acosta thing Jim Acosta has actually ever done, even more Jim Acosta than Jim Acosta making his Twitter header an image of Jim Acosta pointing at Jim Acosta’s Twitter avatar of Jim Acosta https://t.co/9VvwdD7aIV

— Stephen L. Miller (@redsteeze) March 30, 2021

It’s nearly as if Jim Acosta enjoys the noise of Jim Acosta’s name. Who is that douche in the image and what did he compose on his t-shirt

— seegrean (@See_Grean) March 30, 2021

pic.twitter.com/PnjP0NHG1x

— Rule 62 (@kayco76) March 30, 2021

pic.twitter.com/ecOI1nWYUC

— Mike Glenn (@mrglenn) March 30, 2021

You still can’t meme

— Jay Of The J (@ToLearned) March 30, 2021

Do not forget to thank President Trump you tool. Conveniently Smug SORT of congratulates Chris Cillizza for signing on with CNN for another 3 years and ROFL

’12 minutes of must-watch CNN humiliation’: Pam Brown tries pressing liberal election propaganda on Rep. Michael Waltz and it goes SO wrong (watch)

‘ Time to impeach and PROSECUTE’: Blue-check Democrat calls for Biden’s impeachment for pressing COVID vaccine passport

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Tuesday, March 30, 2021

Details of VIP covid testing...

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Details of VIP covid testing…

(Third column, 21st story, link)

Related stories:New Cuomo accuser details forcible kiss as he toured her flood-damaged home…

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BioNTech increases Covid vaccine production target to 2.5bn doses

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Phlebotomy Basics

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A WEEK IN MY LIFE/NURSING STUDENT/VENEPUNCTURE/ MINI HAUL

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#nursing #nursingstudent #venepuncture #haul

HEYYYYYYYYY GUYS ITS BEEN AWHILE 👉👈
BUT I HOPE THIS LOOOOOOOOONG VLOG WILL MAKE UP FOR IT.

IN THIS VIDEO I AM BASICALLY SHOWING YIU HOW MY LAB CLASSES WENT ( WE DID VENEPUNCTURE)
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Degree Trainee Diaries Pad Blo

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Phlebotomist journal/ note pad functions: 120 ruled lined pages 6 x 9 inch size – big adequate for your writing and little adequate to take with you smooth white-color paper, perfect for ink, gel pens, pencils or colored pencils a matte-finish cover for a stylish, expert appearance and feel This journal can be utilized for writing, writing down your fantastic concepts, tape-recording your accomplishments, and more. Use it as a diary or thankfulness journal, a travel journal or to tape your food intake or development toward your objectives. Journals to Write In uses a wide range of journals, so keep one by your bedside as a dream journal, one in your car to tape mileage and costs, one by your computer system for login names and passwords, and one in your purse or knapsack to write down random ideas and motivations throughout the day.

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Every Phlebotomist Problem!

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ability to apply for a job. Returning Candidate? Lab Support Services Specialist/Phlebotomy Job ID 2021-58464 Position Type Full-Time Department… for the technical staff. Phlebotomy procedures including all types of specimen collection techniques. Assist in multiple…
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“Impending doom,” Covid origins, hearts love gravity

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Quartz Daily Brief: “Impending doom,” Covid origins, hearts love gravity

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Britain's Jobless Left Scarred by Lengthening Covid Lockdowns

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Phlebotomy Information

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Phlebotomy Video (hot and I understand it LMFAO Parody)

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Scandal over COVID Vaccine Trial at Peruvian Universities Prompts Outrage

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local media revealed that in October 2020, then-president Martín Vizcarra had received two doses of a vaccine developed by the Chinese state-owned pharmaceutical group Sinopharm. At the time, a phase III clinical trial was under way to test the vaccine at two universities in Peru; Vizcarra was not part of the trial.

Days later, it emerged that a group of around 470 other people—including 100 high-profile individuals such as Peru’s minister of health and Vizcarra’s wife and brother—also got a jab while the trial was in progress. The shots came from a batch of about 2,000 doses that Peruvian officials reportedly negotiated with Sinopharm to protect the medical staff running the trial.

It is not standard practice to vaccinate anyone other than trial participants while a trial is under way—including the medical staff running it, says Euzebiusz Jamrozik, a bioethicist at the Ethox Centre at the University of Oxford, UK.

The laws regulating clinical trials in Peru state that imported, experimental research products such as unapproved vaccines are to be used exclusively for research.

One of the universities running the trial—the National University of San Marcos in Lima—issued a statement condemning the vaccinations of people not enrolled as participants. “Normative and ethical principles of the current regulations and good clinical practices [a set of international medical standards] have been flagrantly violated by using the vaccine in people who are not subjects of research,” said the university’s Faculty of Medicine.

On 19 February, Peru’s National Health Institute (INS) suspended the second university involved, Cayetano Heredia University in Lima, from running new clinical trials. Cayetano has since appointed a panel of former faculty members to investigate the breaches of protocol.

Both universities’ rectors were among the group of non-participants who received shots. Cayetano’s has resigned, but San Marcos’s has not, sparking student protests.

“We share the indignation and deep pain of the [university] community and Peruvian society over the events related to the administration of the additional batch of experimental vaccines sent by Sinopharm,” said Cayetano’s new rector and vice-rector of research in a press release on 1 March.

Nine members of Peru’s Congress have been appointed to oversee an investigation into the vaccinations.

The violation of protocol, and what is seen by many as an abuse of political power by senior officials, has dented confidence in Peru’s politicians and its scientific community, says Mateo Prochazka, a Peruvian epidemiologist working in the United Kingdom. “At a time when we’re creating policies to control the transmission of the virus, we need the public to trust institutions and science, so this is a huge blow for our pandemic control,” he says.

Negotiated Doses

The scandal and investigations follow a period of political instability for Peru, in which Vizcarra was impeached and removed from office over bribery charges. The country is struggling to contain the COVID-19 pandemic: it has officially reported more than 1.4 million cases of COVID-19 and 50,000 deaths. That’s the largest number of deaths by population size in Latin America, according to the COVID-19 tracker run by Johns Hopkins University in Baltimore, Maryland.

The public had seen the vaccine trial, and a subsequent deal for 38 million Sinopharm vaccine doses to distribute in Peru, as a turning point in the battle against COVID-19. As in other low- and middle-income countries, Peru paved a path for itself to obtain vaccines by running the trial. It began administering 300,000 of the Sinopharm doses to health-care workers in February.

When news of Vizcarra’s vaccination came out, he said he had made the “brave decision” to volunteer for the trial. But Cayetano and the INS have since confirmed that he and the other prominent people who received vaccinations from October onwards were not among the study’s 12,000 participants—half of whom received placebos.

Nature’s requests for comment from Vizcarra went unanswered. In a press release from February, Vizcarra said it was a “great surprise” that Cayetano had not included him as a trial participant, and that he did not make his vaccination public “since it would have jeopardized the normal development” of the trial.

Trial Oversight

The researcher leading the clinical trial was Germán Málaga—an internal medicine specialist at Cayetano who is a prominent figure in the medical community.

He oversaw the administration of some of the doses to politicians, including personally attending the vaccination of Vizcarra and his wife at the presidential palace after they requested it, he told a congressional committee investigating the vaccinations on 16 February. He also gave shots to members of his own family.

Cayetano has suspended Málaga from his role as principal investigator of the trial, and from all university activities.

Málaga denies that he broke protocol in administering vaccines to researchers and prominent people. He points out that the trial protocol he wrote states that the additional batch of vaccines would be “administered voluntarily to the research team and study-related personnel”.

The INS approved this protocol. It did not respond to Nature’s requests for comment.

Málaga tells Nature: “We used as criteria the protection of ‘study personnel and related personnel’ in a broad way, and in that extension we included the network of infections of the people we wanted to protect.” He admits that this included members of his family but points out that it also covered medical staff who were working on the front line and thus, in his opinion, needed protection.

According to a press statement released by the INS, Málaga and his staff also administered three doses, rather than the prescribed two, to some individuals outside of the trial, to see whether an additional booster shot would improve protection against the coronavirus.

In response to Nature’s queries about administering unauthorized doses, Málaga defended his choice. He pointed out that when he administered the shots last September and December, the Sinopharm vaccine had not yet been proved efficacious, and thus trying out extra doses on individuals wouldn’t have been taking them away from the public.

“Including an additional dose is a serious, arbitrary breach of protocol” and violates the “fundamental principles of medical ethics,” says Ignacio Maglio, coordinator of science ethics for the UNESCO Bioethics Network who is based in Buenos Aires, Argentina. “It’s a clear example of malpractice in scientific study that could affect the safety of patients and puts at risk the dignity, the integrity and the safety of the research subjects.”

Failed transparency

Clarifying how and why vaccinations were administered outside the trial could help restore confidence in Peru’s science community, says Prochazka, but investigations are complicated by the fact that so many institutions are implicated.

The events in Peru aren’t the only instances in which members of the elite have jumped vaccine queues during the pandemic. In Argentina, for example, a similar list has emerged, resulting in the health minister’s resignation and a national investigation.

Arthur Caplan, head of New York University’s Division of Medical Ethics, says it makes sense to prioritize state leaders such as presidents and prime ministers for vaccines, but there has to be “a clear, principled approach to distribution”—and transparency.

“The Peruvian case seems to be at the extreme of ethical outrage,” he says. “Vaccinations have to be built on trust, not who you know.”

This article is reproduced with permission

Read more about the coronavirus outbreak from Scientific American here. And read coverage from our international network of magazines here.

ABOUT THE AUTHOR(S)

Luke Taylor

    Luke Taylor is a freelance journalist covering Colombia, Venezuela and wider Latin America. He is particularly interested in the relationship between political and military conflict and issues like deforestation, the international drug trade and migration.

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    Keeping covid vaccines cold isn’t easy. These ideas could help.

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    In order to truly end the pandemic, it will be essential to get vaccines to all parts of the world. The first part of that challenge involves boosting the supply and securing doses for all, but even if enough vaccines become ready, the next hurdles are storage and distribution. For some covid vaccines, that means shuttling through what’s known as the “cold chain,” a series of very well chilled environments—planes, boats, trucks, even boxes cooled with liquid nitrogen—to ensure that shots don’t perish before they get to the people who need them. Currently, Pfizer’s vaccine needs to be kept at -80 °C for long-term storage, and Moderna’s at -20 °C. For reference, home refrigerators maintain temperatures of about 2 to 4 °C.

    “These requirements are difficult,” says Darrick Carter, the chief scientific officer of HDT Bio, a biotechnology company based in Seattle that’s developing immunotherapies for underserved regions of the world. 

    Some vaccines are already able to handle more typical refrigerator temperatures: Johnson & Johnson’s and AstraZeneca’s, for example. But messenger RNA (mRNA) vaccines such as those by Pfizer and Moderna, which have proved more effective and will be far easier to modify to fight new variants, have a shelf life of just a few hours once they’re out of very cold temperatures.

    Those temperature needs are an issue in places where access to ultra-cold freezers or even electricity is scarce, but keeping vaccines cold can be a struggle even in rich countries like the US.

    To get around these problems, scientists and engineers are taking two different routes: changing parts of the cold chain, or changing the vaccines themselves.

    How cold temperatures protect fragile vaccines

    MRNAs are strings of nucleic acids that give cells instructions on what proteins to make—and with the right tweaks, they can give the body directions on how to fight diseases, including covid-19. They’re essential components of vaccines like Pfizer’s and Moderna’s. But they’re fragile: without some sort of protective coating, the mRNAs in a vaccine degrade quickly. To prevent that damage, vaccine makers keep these mRNAs protected, essentially putting them in safe bubbles. 

    Currently, that bubble is a lipid nanoparticle—which, on a basic level, is a very tiny fat droplet. For Drew Weissman, one of the pioneers of mRNA vaccine technology, it took more than 10 years and about 40 different formulas to discover that lipid nanoparticles worked the best. Not only did they keep particles from being degraded, but they also boosted the response of the immune system. 

    By the time Weissman and his colleagues began testing mRNA vaccines, about six years ago, it was evident that the lipid nanoparticles required ultra-cold storage, he says. That’s because it takes more energy to freeze fats than, say, water. “The idea for storage was that you wanted to freeze the fat droplets so they wouldn’t degrade, aggregate, or fuse together,” Weissman says. “That’s how -80 °C started.” 

    Pharmaceutical companies have been testing various storage temperatures, hoping to bring them up a bit. Moderna tested how its vaccine would fare at -20 °C for long-term storage and found it to remain stable until the dose’s expiration date. Pfizer and BioNTech didn’t look at -20 °C storage until recently, but in late February, the US Food and Drug Administration approved the vaccine for storage at that temperature for up to two weeks.

    Stronger bubbles could add stability

    Scientists are now experimenting with other ways to make mRNA vaccines even more temperature stable. 

    “The more thermostable [a vaccine or pharmaceutical product], the better,” says Pat Lennon, who leads the cold chain team at PATH, a global health organization that’s working to improve health equity. “You can take the pressure off the cold chain.” 

    For example, Weissman says, some vaccine developers are altering the concentration of sugars in the formulas they use. Sugars can coat fat droplets—the way flour can coat bread dough—and prevent the lipid nanoparticles from sticking together, allowing doses to stay stable and usable for longer.

    HDT Bio, the biotechnology company in Seattle, has an alternative solution. Working with Deborah Fuller, a microbiologist at the University of Washington, it’s pioneering a different kind of protective bubble for the mRNAs. If it works, it would mean that an mRNA vaccine for covid-19 could be stable in a regular fridge for at least a month, or at room temperature for up to three weeks. 

    Their method: instead of encasing the mRNA in a lipid nanoparticle, they’ve engineered molecules called lipid inorganic nanoparticles, or LIONs. The inorganic portion of the LION is a positively charged metal particle—so far they’ve been using iron oxide. The positively charged metal would bind to the negatively charged mRNA, which wraps around the LION. The resulting particle is solid, which creates more stability and reduces the reliance on refrigeration. 

    “The cold chain has always been an issue for [the] distribution of vaccines, and it’s only magnified in a pandemic.”

    Deborah Fuller

    HDT Bio initially developed LIONs to treat liver cancer and tumors in the head and neck, but when the pandemic hit, they pivoted to trying the particles with mRNA vaccines. Early preclinical trials in nonhuman primates showed that the LION, combined with an mRNA vaccine for covid-19, worked as they’d hoped.

    Carter of HDT Bio says that in an ideal situation, LIONs could be sent to clinics worldwide in advance, to be stored at room temperature or in a regular refrigerator, before being mixed into vaccine vials at clinics. Alternatively, the two could be premixed at a manufacturing facility. Either way, this method would make doses stable for at least a month in a regular refrigerator. 

    Fuller says that some scientists have criticized the need for two vials—one for the LION and another for mRNA before they’re mixed together. “But I think the advantages of having an effective product more amenable to worldwide distribution outweighs those negatives,” she says.

    HDT Bio is applying for permission to start human clinical trials in the US and is looking to start clinical trials in India this spring. In the US, it faces some unique challenges in FDA regulation, since the LION particles would be considered a drug separate from the vaccine. Regulators in Brazil, China, South Africa, and India—where HDT Bio is hoping to launch its product—don’t consider the LION a drug because it isn’t the active component, says Carter, meaning that there would be one less layer of regulation than in the US.

    For now, it’s still very much an early-stage technology, says Michael Mitchell, a bioengineer at the University of Pennsylvania who works on drug delivery systems. He stresses that more research should reveal whether the iron oxide causes any side effects.

    Keeping the cold chain properly chilled

    While changing vaccines themselves may take time, other ways of managing the cold chain are already happening, especially in low- and middle-income countries where electricity and refrigeration are harder to come by. 

    PATH, the global health organization, developed temperature-tracking methods for vaccine distribution a generation ago by designing stickers that change color with increased heat, taking into account a vial’s cumulative exposure to temperatures outside its required refrigeration range. This information helps reduce spoilage and wasted doses—if, say, a freezer goes out, medical staff don’t have to assume vaccines are spoiled.

    More than 9 billion of these stickers have helped in the successful distribution of various vaccines worldwide, and as covid-19 vaccines finally roll out to more countries, they’ll be another way of ensuring proper temperatures. 

    Then there are the refrigerators themselves.

    In 2009, engineers at the Bill and Melinda Gates Foundation in Seattle started designing an off-grid refrigerator for use in places with little to no infrastructure for the cold chain.

    The result was the Arktek—a barrel-size super Thermos intended to refrigerate vaccines or other biological samples. Different substances can prime it to store materials at different temperatures: dry ice can keep samples at -80 °C, while a mixture of water and ethanol can set the temperature at around -20 °C. If it holds 450 vials, they will stay chilled for three to four weeks, while 750 vials can remain cold for at most two weeks, says Daniel Lieberman, Arktek’s inventor at GHLabs, a nonprofit created by the Gates Foundation. Because the device has no electrical parts, it’s extremely hard to break: it will be rendered useless only if someone manages to puncture the vacuum seal.

    The device was first put to the test in 2014, when Ebola ravaged villages in West Africa. The vaccine available at the time, developed by Merck, required refrigeration at -80 °C. When Arktek was deployed in the field in 2015, it played a role in vaccinating 8,000 individuals and helped stop the Ebola outbreak.

    Since then, the 3,000 or so units have remained in countries throughout Africa, says Lieberman, and are used to store routine vaccines for diseases such as measles, polio, chicken pox, and hepatitis. Various international organizations, such as UNICEF and Doctors Without Borders, purchase Arkteks for countries that need them. Around 1,000 new units have been manufactured specifically to handle distribution of covid-19 vaccines, says Shouda Li, the general manager of the device’s manufacturer, Aucma, which is based in China. Those new units will be sent to South and Southeast Asia, the Middle East, and some countries in Latin America, Li says.

    There is one more experimental approach in development—one that would avoid the cold chain altogether, says Weissman. Some developers have dehydrated the current covid vaccines. Dehydration would make the dose stable at room temperature indefinitely, says Weissman, until it is reconstituted right before use. The drawback is that it would make the vaccine harder to produce: dehydration adds extra processing, which would significantly increase the manufacturing costs. Still, Pfizer says it may have this ready by 2022

    For mRNA vaccines, reliable room-temperature storage would be a game changer, eliminating one long-standing obstacle to vaccines for all.

    Fuller says: “The cold chain has always been an issue for [the] distribution of vaccines, and it’s only magnified in a pandemic where it’s so crucial to vaccinate all corners of the globe as quickly as possible.”

    This story is part of the Pandemic Technology Project, supported by The Rockefeller Foundation.

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    Phlebotomy Class Trainee

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