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不堪重负的系统导致冠状病毒测试处理不当,延误

2020-07-27 09:22   美国新闻网   - 

排队两个小时后,亚特兰大的太阳打在她的汽车引擎盖上,安德烈·米切尔在得来速测试站停了下来。她摇下车窗,从一名志愿者那里拿走了她唯一的条形码工具包。

但是包里有别人的名字。

米切尔,42岁,告诉美国广播公司新闻:“我得到了这位女士的注意,‘嘿,你给了我一个错误的人的测试,’”“我们有相同的首字母,但我想,‘这不是我的名字,这不是我的号码,这不是我的生日。“这不是我,”"

随着对测试随着价格的上涨而上涨新冠肺炎在某些情况下,负责向全国传递结果的主要实验室已经明确警告他们已经不堪重负。美国最大的测试公司之一Quest周一警告称,测试的迫切需求“继续超过(他们的)能力”,尤其是在目前面临的地区病例数量不断增加:南部、西南部和西部。

被迫面对迅速传播专家称,一个被捆绑的医疗保健系统“病毒”正竭力跟上形势——引发通信故障、文书疏忽、标签错误、处理不当和样本放错地方。

美国临床化学协会主席卡门·威利博士在接受美国广播公司采访时表示:“有许多步骤可能出错。”“我们有如此多的手动和非常坦率的临时流程,这是人为的错误。”

“这就像试着从飞机上跳下来,制造一个可以工作的降落伞,同时安全着陆。”

美国已经努力推出高效及时的测试科学家和临床医生说,从大流行开始。一项联邦审查证实,疾病控制和预防中心在1月份生产的早期检测试剂盒可能受到了污染,这也可能是疾病控制和预防中心在国内大流行早期延迟分发检测结果的原因,而美国卫生和公众服务部的一份报告称,启动检测存在“时间压力”,而且“实验室实践可能不足以防止污染风险。”

美国卫生官员并没有一开始就寻求私营部门来开发测试,而是依赖于疾病预防控制中心的测试。疾病预防控制中心的检测供应不足,加上原本狭窄的检测标准,意味着没有足够多的美国人能够接受检测。美国已经进行了超过5100万次试验;卫生与公众服务部的助理卫生部长布雷特·吉尔洛星期四对记者说,随着大流行的持续,大型商业实验室的周转时间越来越长。

周日,吉尔洛强调了加快周转时间的重要性。

Giroir告诉CNN:“我一开始就说,除非我们在24小时内获得周转时间,否则我们永远不会对检测感到满意,我也很乐意在任何地方进行现场检测。”“我们还没有到那里。我们正在尽一切努力做到这一点。”

LabCorp和Quest现在都已获得紧急授权,可以开始“集中测试”他们的样本,以试图在这样的洪水中“确保测试可用”,LabCorp在周六的一份声明中说。

卫生官员说,从那以后,即使测试的负担已经转移到国营、地方和私人实验室,但“时间压力”和缓解压力的努力都没有消退。

奥古斯塔大学卫生系统副总裁兼首席医疗官菲利普·库勒博士在接受ABC新闻采访时表示:“像盖子这样简单的东西从标本上脱落下来,就没有保存下来。”格鲁吉亚现在面临一些最新的病例激增,7月25日报告了近3800例新病例。“我能想到一个例子,在运输途中,标本被直接放在冰里,它浸透了所有的标签。所以,标签掉了。与其冒误报的风险,你还不如放弃它们。”

2020年7月5日,佛罗里达州迈阿密花园的硬石体育场外,一排排汽车在一个免下车冠状病毒检测点等候

诺斯威尔实验室的执行主任德韦恩·布雷宁博士告诉美国广播公司新闻,负责全国范围内检测的实验室现在发现自己受到了双重打击。

布莱宁说:“你有更多的测试需求,从推动重新开放,加上一整串的国家现在与增加的需求,因为每个人都生病了。”“这就像是双重打击。不幸的是,我认为我们还没有触及最糟糕的部分。”

“一个微妙的问题”:妥协的测试让人产生怀疑

米切尔已经战胜了冠状病毒。她的第一个结果是“不确定的。”随着她的症状恶化,重新测试证实了她已经感觉到的和害怕的:她是阳性的。仍在恢复过程中,她第三次回去接受测试。

“另一个人的错误就像我的错误一样——你想给别人宽限,因为他们想尽可能快地完成工作。但这是你的生活。”

Quest的发言人金伯利·戈罗德告诉美国广播公司:“如果一个人没有得到他们想要的结果,通常是有原因的。”“有时候,原因就在翻译中消失了。有些情况下无法进行检测,或者样本收集不当,但我们会对所有内容进行两次或三次检查,以确保我们处于最佳状态,并全天候为人们提供准确的结果,因为我们确实了解这一点有多重要。”

LabCorp没有回答有关测试丢失或处理不当的具体问题,但一位发言人在一份声明中强调,“供应品和设备的需求和限制显著增加”,而且公司“继续致力于尽一切努力应对健康危机。”

佛罗里达也出现了对检测有效性产生怀疑的样本泄露的案例,周六,该州的冠状病毒病例总数超过了纽约。

5月下旬,佛罗里达州紧急事务管理部门宣布,他们已经“意识到”全州范围内实施的1700多项冠状病毒检测在运输途中遭到破坏。

该部门表示:“这些人将被优先安排在他们最初被测试的地方进行重新测试。”声明。

它直接跟随在全国经营着45个医院校园的基督复临健康,宣布他们取消了与他们的一个合作实验室的合同,理由是未能履行其义务并影响了佛罗里达中部的25000多项测试。另一个声明从同一天开始,又有8000人在西佛罗里达分部受到实验室问题的影响。

“这种情况已经造成了不可接受的延误,我们对测试的可靠性没有信心。”

2020年6月27日,医务人员准备对数百名在凤凰城西部玛丽维尔社区排队的人进行免费的COVID-19测试。

专家们描述说,在幕后,收集和处理样本是一个复杂的过程,要相信并在多组人手里传递,而且通常要运送到全国各地。

西奈山医院院长大卫·赖克博士告诉美国广播公司新闻:“这是一个微妙的问题。”“供应链中有这么多环节,其中一个环节很容易失败。要做到这一点,后勤工作非常复杂。”

威利说,样品必须保存在高度受控的条件下,并与外界隔绝,以免受到极端温度等环境的影响。随着热点现在在美国一些较热的地方爆发,保持样品完好几个小时,有时甚至几天被证明是具有挑战性的。据华盛顿卫生部称,在6月中旬,超过400个COVID-19测试样本在受热后无法处理,华盛顿美国广播公司下属机构WJLA报道。

卫生部在一份声明中写道:“我们对由此带来的不便表示歉意,并正在采取措施——比如在每个检测点增加制冷设备——以确保问题不会再次出现。”

打电话和追踪案件

专家告诉美国广播公司新闻,测试缺失或处理不当的情况并不构成绝大多数错误,相反,一个断开的系统可能会很麻烦。

德克萨斯州哈里斯县公共卫生执行主任乌马尔·沙阿(Umair Shah)博士说,“这感觉就像在逆流而上。”该州创下了一天COVID死亡和住院治疗的历史新高。

沙阿说:“我们总是不得不转向。”“这是实验室信息的不完整和延迟。老实说,它已经开始真正影响当地社区。”

2020年7月10日,亚利桑那州图森市的亚利桑那大学,在接受COVID-19抗体测试之前,奥罗谷医院的员工吉利安·戈尔德(Jillian Golder)检查了她的体温。

沙阿知道全国各大实验室和医院之间的过时数据共享系统所带来的挑战。最近,当一个实验室试图大批量发送测试结果时,他办公室的传真机突然启动,失控地将文件喷到地板上。

来自全国各地的医疗保健专业人员多次向美国广播公司新闻频道描述了他们对阻碍他们工作的落后的、经常是混乱的良好信息流的失望。

“所以我们只能知道你的出生日期。或者我们会有你的地址,但没有你的电话号码。或者我们会有一个数字,但这是错误的,”沙阿说。“现在这个名字拼错了,但是其他的一切看起来都一样,或者可能不完全一样。现在我们得回去弄清楚,‘是不是我们已经联系过的那个人?’"

沙阿继续说:“所以我们正试图找出如何中断病毒的传播,但首先我们必须去追踪的情况下。”“那么进行有意义的联系追踪就太晚了,因为你错过了那个窗口。这是一个遍及全国的系统性问题,这是一个真正的耻辱。”

在华盛顿特区,乌苏拉·桑德斯特罗姆等了两个多星期才拿到结果。她在6月下旬去做了测试,但在7月的第一周没有听到任何消息。发现很难知道该向谁询问延误的原因,她拨打了该市的热线。她被告知她的结果已经准备了一个星期,但是她的名字在她的档案中被记录为“桑德森·桑德森”。她的结果是否定的,但在7月中旬与美国广播公司新闻的电话交谈中,桑德斯特罗姆说她的病人档案仍未修复。

“这需要额外的工作来弄清楚,‘我是谁,我该怎么做,弄清楚发生了什么?’“桑德斯特罗姆说。”这些风险很高,因为它是COVID,人们需要知道。"

2020年7月24日,在佛罗里达州圣彼得堡的玛哈菲剧院,一名医务人员在一个免下车的COVID-19测试点从一辆汽车上取拭子

那些在前线抗击病毒的人告诉美国广播公司新闻,他们已经筋疲力尽了。

亚利桑那州是最近的热点地区之一,该州的传染病流行病学专家、传染病预防专家萨斯基亚·波佩斯库博士说:“我们都筋疲力尽了,只是烧焦的松脆程度不同。”“从三月到四月,我们的重症监护室里挤满了科维德病人。所以这是一场马拉松,不是短跑。然而,我们不得不同时进行马拉松和短跑。”

波佩斯库有大流行防备的背景,并且是那些负责报告关于COVID患者的所有数据的人之一,一点一点,手动输入,同时依靠被淹没的实验室。她担心测试的延迟会影响她能够报告的数据。

波佩斯库继续说:“这就是我们训练的目的,但这并没有减少我们的疲劳和挑战。”“我认为,你知道,这可以保证人们的安全——而且必须完成。”

Falling through the cracks: Overwhelmed system leads to coronavirus tests mishandled, delayed

Two hours after getting in line, with the Atlanta sun beating down on the hood of her car, Andrea S. Mitchell pulled up at the drive-thru test site. Rolling down the window, she took her uniquely barcoded kit from a volunteer.

But there was someone else's name on the bag.

"I got the lady's attention that, 'Hey, you gave me the wrong person's test,'" Mitchell, 42, told ABC News. "We had the same initials, but I was like, 'This isn't my name, this isn't my number, this isn't my birthday. This isn't me.'"

As the demand fortestingsurges with the rise inCOVID-19cases, major labs tasked with delivering results to the entire country have explicitly warned they're overwhelmed. Quest, one of the largest testing companies in the U.S., cautioned Monday that the urgent need for testing "continues to outpace [their] capacity," especially in the regions now facingrising numbers of cases: the South, Southwest and West.

Forced to confront therapidly spreadingvirus, a strapped health care system is straining to keep up -- fomenting communication breakdowns, clerical oversight, mislabeled, mishandled and misplaced samples, experts say.

"There are multiple steps where mistakes can happen," Dr. Carmen Wiley, president of the American Association for Clinical Chemistry, told ABC News. "We have so many manual and quite frankly ad hoc processes in place, it's human error."

"It's like trying to jump out of an airplane, and build a parachute that works, and land safely all at the same time."

The U.S. hasstruggled to roll out efficient and timely testingfrom the start of the pandemic, scientists and clinicians say. A federal review confirmed that early test kits produced by the Centers for Disease Control and Prevention in January were likely contaminated -- and likely what delayed the CDC's distribution of tests during those early days of the domestic pandemic -- while a Department of Health and Human Services report cited "time pressure" to launch testing, and "lab practices that may have been insufficient to prevent the risk of contamination."

Instead of initially enlisting the private sector to develop tests from the start, the U.S. health officials relied on CDC's tests. Insufficient supply of testing from the CDC along with an originally narrow testing criteria, meant that not enough Americans could get tested. The U.S. has conducted over 51 million tests; as the pandemic has worn on, turnaround time for big commercial labs has gotten longer, Health and Human Services' Assistant Secretary for Health Adm. Brett Giroir told reporters Thursday.

On Sunday, Giroir emphasized the importance of faster turnaround times.

"I started out by saying that we are never going to be happy with testing until we get turnaround times within 24 hours and I would be happy with point-of-care testing everywhere," Giroir told CNN. "We are not there yet. We are doing everything we can to do that."

LabCorp and Quest both have now received emergency authorization to begin "pool testing" their samples in an attempt to "ensure testing is available" amid such inundation, LabCorp said in a statement Saturday.

Since then, even as the burden of testing has shifted to state-run, local and private labs, neither that "time pressure" nor the scramble to alleviate it, have ebbed, health officials say.

"Something as simple as the lid comes off the specimen, and it's not preserved," Dr. Phillip Coule, vice president and chief medical officer of Augusta University Health System, told ABC News. Georgia now faces some of the latest case surges, reporting almost 3,800 new cases on July 25. "I can think of one example where [in transit] the specimens were placed directly in the ice, and it soaked through all the labels. So, labels came off. And rather than run the risk of misreporting those, you have to discard them."

Labs responsible for tests nationwide now find themselves pummeled two-fold, Dr. Dwayne Breining, executive director of Northwell Labs, told ABC News.

"You've got more demand for tests from pushes to reopen -- plus a whole bunch of states now with increased demand because everybody's getting sick," Breining said. "It's like a double whammy. And unfortunately, I don't think we've hit the worst part of it yet."

'A delicate matter': Compromised tests cast doubt

Mitchell had already weathered a bout with coronavirus. Her first results returned "inconclusive." As her symptoms worsened, a retest confirmed what she already felt and feared: She was positive. Still in the process of recovery, she went back a third time to get tested.

"The mistake of another person like what happened with mine -- you want to extend grace to people, because they're trying to get as much done as fast as possible. But it's your life," Mitchell said.

"If a person is not getting their results, usually, there's a reason," Quest spokesperson Kimberley Gorode told ABC News. "And sometimes the reason is lost in translation. There are instances where a test can't be performed, or the specimen isn't collected properly, but we are double and triple-checking everything to make sure that we're on top of it, working 24/7 to get people results and to be accurate because we do understand how important this is."

LabCorp did not respond to specific questions regarding lost or mishandled tests, but a spokesperson emphasized in a statement there has been a "significant increase in demand and constraints in the availability of supplies and equipment," and that the company "continues to be committed to doing everything we can to respond to the health crisis."

Cases of compromised samples casting doubt on tests' validity have also emerged in Florida, where Saturday, total coronavirus cases statewide surpassed New York.

In late May, the Florida Division of Emergency Management announced they had been "made aware" that more than 1,700 coronavirus tests administered across the state had been damaged in transit.

"These individuals will be prioritized for retesting at the site where they were originally tested," the Division said astatement.

It directly followed AdventHealth, which operates 45 hospital campuses across the country,announcingthey had canceled a contract with one of their partnered labs, citing a failure to fulfill its obligation and impacting over 25,000 tests in Central Florida. Anotherstatementfrom the same day noted another 8,000 people had been impacted by a lab's issues throughout their West Florida division.

"This situation has created unacceptable delays, and we do not have confidence in the reliability of the tests," AdventHealth's statement read.

Behind the scenes, collecting and processing samples is an intricate process, trusted to and passed among multiple sets of hands, and often shipped cross-country, experts describe.

"It's a delicate matter," Dr. David Reich, president of Mount Sinai Hospital, told ABC News. "There are so many links in the chain and it's very easy for one of them to fail. It's logistically complex to do this well."

Samples must be kept in highly controlled conditions and shielded from any outside, compromising circumstances -- like extreme temperatures, said Wiley. As hotspots now flare in some of the hotter spots in the nation, keeping samples intact for hours and sometimes even days has proved challenging. In mid-June, more than 400 COVID-19 testing samples were not able to be processed after being exposed to heat, according to the D.C. Department of Health,Washington ABC affiliate WJLA reported.

"We apologize for the inconvenience and are taking steps — such as the addition of more refrigeration at each testing site — to ensure the issue does not arise again," the health department wrote in a statement.

Playing telephone and tracing the case

Cases where tests go missing or mishandled don't make up an overwhelming majority of errors, experts told ABC News, but rather a disconnected system can prove troublesome.

"It feels like we're swimming upstream," Dr. Umair Shah, executive director of Harris County Public Health in Texas, a state hitting its record-high one-day COVID deaths, and hospitalizations.

"We're constantly having to pivot," Shah said. "It's been the incompleteness and delay of the lab information. And it's honestly started to really impact local communities."

Shah knows the challenges of the at-times antiquated data-sharing systems across the nation, between major labs and hospitals. Recently when one lab tried to send its test results in bulk, his office's fax machine kicked into hyper drive, spewing papers uncontrollably onto the floor.

Health care professionals from across the country repeatedly described to ABC News frustrations with the lagging, often-muddled flow of good information impeding their work.

"So it'll turn out we'll only have your date of birth. Or we'll have your address, but not your phone number. Or we'll have a number, but it's wrong," Shah said. "Now the name is misspelled, but everything else appears to be the same or maybe not quite. Now we've got to go back and figure out, 'Is it the same person that we've already reached out to?'"

"So we're trying to figure out how to interrupt the virus's transmission, but first we had to go trace the case," Shah continued. "Then it's too late to do meaningful contact tracing because you've missed that window. That's a systematic issue across this country, and that is a real shame."

In Washington, D.C., Ursula Sandstrom waited over two weeks for her results. She went for testing in late June, but hadn't heard anything through the first week of July. Finding it difficult to know who to ask about the delay, she called the city's hotline. She was told her results had been ready for a week, but her name was recorded as "Sandstron Sandstron" in her file. Her results were negative, but by a mid-July phone conversation with ABC News, Sandstrom says her patient file still had not been fixed.

"It took extra work to figure out, 'Who do I, how do I, figure out what's going on?'" Sandstrom said. "These are high stakes because it's COVID and people need to know."

Those on the front lines fighting the virus tell ABC News they're worn out.

"We're all burnt out, just varying levels of burnt crisp," said Dr. Saskia Popescu, an infectious disease epidemiologist and infection preventionist in Arizona, one of the most recent hotspots. "We've had an entire ICU full of COVID patients since like, March, April. So this is a marathon, not a sprint. And yet we're having to do a marathon and a sprint at the same time."

Popescu has a background in pandemic preparedness, and is among those responsible for reporting all the data on COVID patients, point by point, input manually, while relying on inundated labs. She fears the delays in testing will impact the numbers she's able to report.

"This is what we trained for, but that doesn't make it any less exhausting or the challenges any less," Popescu continued. "I see it as, you know, this keeps people safe -- and it has to get done."

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