Regulators suspend Missouri nursing home COVID-19 test lab

Star Tribune

COLUMBIA, Mo. — A federal judge refused to intervene Wednesday to keep open a Missouri lab that handled coronavirus tests for about 2,500 nursing homes in 11 states after the federal government suspended the lab for what it alleged were serious violations that put patients' health at risk.

U.S. District Judge Douglas Harpool said that the lab, Gamma Healthcare, was in effect asking him to step into a role that belongs to federal health and safety regulators.

Missouri nursing homes are worried that loss of the lab's services will slow down testing for their elderly and frail patients.

Gamma Healthcare's Poplar Bluff lab handled COVID-19 testing for thousands of long-term care centers in Arkansas, Illinois, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Oklahoma, Tennessee and Texas.

Attorneys for the Medicare agency, or CMS, in court documents wrote that two testing machines at the lab operated for months producing false-negatives on over a quarter of known-positive COVID-19 samples. Regulators also found multiple false-positive COVID-19 test results at the lab.

A CMS spokeswoman in an email said following federal lab regulations is especially important during the coronavirus pandemic to ensure accurate test results and slow the spread of the virus.

Gamma Healthcare lawyers said the Poplar Bluff lab voluntarily stopped COVID-19 tests earlier this month in response to issues raised by regulators. But attorneys said the labs have fixed the issues and sued in federal court to stay open, arguing that suspending the labs' licenses would leave thousands of nursing homes "without crucial laboratory services."

Harpool on Wednesday denied Gamma Healthcare's request.

In his ruling, Harpool wrote that the company was asking him to "second guess" CMS's authority to decide if the labs "present a threat to public safety." He said that's beyond his jurisdiction and said Gamma Healthcare needs to go through other administrative channels first to appeal CMS's decision.

The Missouri health department first identified problems at the lab during a June 23 inspection on behalf of CMS. Regulators found issues including failure to prevent specimen contamination and lack of procedures to prevent COVID-19 from spreading between lab workers.

Gamma Healthcare has argued that the issues CMS pointed out have been fixed and that regulators are not giving the lab a fair chance to show how it's addressed the problems.

For example, Gamma Healthcare officials said issues with false-negative COVID tests could have been caused by technical problems with how CMS checked them and that internal reviews found the instruments were working properly.

"After review of the instrumentation (four instruments) used at GHC, and after testing thousands of patients, all equipment responses were identical and there was no evidence of false-negative data," Gamma Healthcare Director of Laboratory Services Dr. David Smalley said.

CMS attorneys wrote in court documents that Gamma Healthcare repeatedly told regulators that the labs had "shaped up."

"But talk is cheap," according to a CMS court filing. "In early October, surveyors revisited the labs, and the state of the labs remained largely the same. At both labs, the lab directors consistently failed to provide management and direction to ensure valid and reliable lab test results."

Gamma Healthcare attorney Mark Weller said the Poplar Bluff lab sent COVID-19 tests to American Esoteric Lab in Memphis, Tennessee and Supreme in the Dallas area after it stopped processing those tests.

But he said more urgently, the suspension means an end to tests to detect diabetes, cancer, urinary infections and other illnesses among nursing home residents and other patients.

"Patient care will suffer," Weller said in an email.

It's unclear whether the nursing homes have found other labs to handle routine testing.

The Missouri Health Care Association, which represents nursing homes and other long-term care centers in the state, said one fewer lab will make a big difference.

"Any instate lab we lose for COVID testing will have an impact and is especially devastating given the testing frequency our facilities are required to follow under the current CMS guidance," Executive Director Nikki Strong said in a statement.

rn//Load jQuery library using plain JavaScriptrn(function(){rn var newscript = document.createElement('script');rn newscript.type="text/javascript";rn newscript.async = true;rn newscript.src="";rn (document.getElementsByTagName('head')[0]||document.getElementsByTagName('body')[0]).appendChild(newscript);rnvar newscript2 = document.createElement('script');rn newscript2.type="text/javascript";rn newscript2.async = true;rn newscript2.src="";rn (document.getElementsByTagName('head')[0]||document.getElementsByTagName('body')[0]).appendChild(newscript2);rn})();rn/********TEST CODE for METER SNOW PLOW ANALYTiCS*******************/rnvar meter = {};rn$(document).ready(function(){rn // console.log("this loads well");rn $('.js-optimizely-click-goal').click(function(){rn // console.log(this);rn meter['type'] = $("input[name="offer"]").val();rn if(meter['type'] = 131){meter['type'] = "Premium Digital Access";}rn else if(meter['type'] = 130){meter['type'] = "Sunday Print + Digital";}rn else if(meter['type'] = 129){meter['type'] = "7-Day Print + Digital";}rn else if(meter['type'] = 128){meter['type'] = "Sunday Print";}rn meter['date'] = new Date().toLocaleString();rn // console.log(meter['type']);rn // console.log(meter['date']);rn var json_meter_cookie = JSON.stringify(meter);rn Cookies.set('meter_sign_up', json_meter_cookie); rn rn });rn});rn/************************************************************************/rn // FACEBOOK TRACKING PIXEL #1rn !function(f,b,e,v,n,t,s)rn {if(f.fbq)return;n=f.fbq=function(){n.callMethod?rn n.callMethod.apply(n,arguments):n.queue.push(arguments)};rn if(!f._fbq)f._fbq=n;n.push=n;n.loaded=!0;n.version='2.0';rn n.queue=[];t=b.createElement(e);t.async=!0;rn t.src=v;s=b.getElementsByTagName(e)[0];rn s.parentNode.insertBefore(t,s)}(window,document,'script',rn '');rn fbq('init', '590074241155998'); rn fbq('track', 'ViewContent');rn rnrn{% endblock %}"},"start":""},{"id":"limit-signup","count":12,"action":"ignore","mute":true,"action_config":{"template":"{% extends "grid" %}rnrn{% block heading_text %}Youu2019ve read your 10 free articles for this 30 day period. Sign up now for local coverage you wonu2019t find anywhere else, special sections and your favorite columnists. StarTribune puts Minnesota and the world right at your fingertips. {% endblock %}rnrn{% block last %}rn{{ parent() }}rn{# limit Krux pixel from #}rnrnrn{% endblock %}"},"start":""},{"id":"meter-desktop-331","count":10,"action":"ignore","mute":false,"action_config":false,"start":""},{"id":"PDA991499opt","count":9,"action":"ignore","mute":true,"action_config":false,"start":""},{"id":"limit","count":8,"action":"inject","mute":false,"action_config":{"template":"rn.o-overlay,rn.o-overlay * {rn display: block;rn box-sizing: border-box;rn}rnrn.o-overlay {rn position: fixed;rn top: 0;rn left: 0;rn width: 100%;rn height: 100%;rn font-size:14px;rn background: rgba(0, 0, 0, 0.8);rn z-index: 999999;rn opacity:1;rn transition:all .01s;rn}rn.o-overlay h1 {rn font-family:popular-bold, 'Popular';rn font-size:28px;rn}rnrn.o-modal {rn width: 100%;rn max-height: 100vh;rn overflow: auto;rn position: absolute;rn top: 50%;rn left: 0;rn -webkit-transform: translateY(-50%);rn transform: translateY(-50%);rn}rn.o-modal-middle {rn padding:5px 5px;rn position:relative;rn background:#F6E463;rn text-align:center;rn border-top:1px solid rgb(246, 228, 99);rn -webkit-box-shadow:0px 0px 0px rgba(0,0,0,0);rn box-shadow:0px 0px 0px rgba(0,0,0,0);rn}rn.o-modal-inner {rn background: #ffffff;rn margin: 0 auto;rn width: 100%;rn max-width: 600px;rn position: relative;rn}rnrn.o-button {rn display: inline-block;rn font: bold 18px/1 Whitney, sans-serif;rn margin: 0;rn padding: 0;rn border: none;rn text-decoration: none;rn color: #fff;rn background: #00824A;rn padding: 15px 20px;rn border-radius: 4px;rn border: 2px solid rgba(0, 0, 0, 0.1);rn -webkit-transition: all .1s;rn transition: all .1s;rn cursor: pointer;rn text-shadow: 0 1px rgba(0, 0, 0, 0.2);rn}rn.o-button:hover {rn text-decoration: none;rn color: #fff;rn border-color: transparent;rn background: #00824A;rn opacity:0.9;rn}rn.o-cta {rntfont:bold 38px/1 Whitney, sans-serif;rntcolor:#00824A;rntpadding:5px 0px;rntdisplay:block;rnttext-align:center;rntoverflow:hidden;rntcursor:defaultrn}rn.o-block {rn text-align: center;rn font-family:'Whitney',sans-serif;rn}rn.o-block img {rn width: 150px;rn height: auto;rn display: block;rn margin: 0 auto 10px;rn}rn.o-block .text-left {rn text-align:left;rn}rn.o-block.pad {rn padding: 10px;rn}rn.o-block.pad-top {rn padding-top: 30px;rn}rn.o-block.pad-right {rn padding-right: 30px;rn}rn.o-block.pad-bottom {rn padding-bottom: 30px;rn}rn.o-block.pad-left {rn padding-left: 30px;rn}rn.o-block.shadow-out {rn box-shadow: 0 0 7px 0 rgba(0, 0, 0, 0);rn}rn.o-block.shadow-in {rn box-shadow: inset 0 0 7px 0 rgba(0, 0, 0, 0);rn}rnrn.o-small {rn color: #010101;rn font: italic normal 13px/1 Whitney, sans-serif;rn margin: 10px 0;rn}rn.o-small:first-child {rn margin-top: 0;rn}rn.o-small:last-child {rn margin-bottom: 0;rn}rn.o-small.left {rn text-align: left;rn}rnrn.o-small a {rn display: inline-block;rn color: inherit;rn text-decoration: underline;rn}rn.o-small a:hover {rn color: black;rn text-decoration: underline;rn}rnrn.o-bg-green {rn background:#86cff2;rn color:#ffffff;rn}rnrn.o-info {rn display:inline-block;rn position:absolute;rn bottom:20px;rn right:20px;rn overflow:visible;rn z-index:1;rn}rn.o-info:hover {rn padding-left:2em;rn padding-top:2em;rn}rn.o-info:hover div {rn display:block;rn}rn.o-info button {rn width:1.5em;rn height:1.5em;rn border-radius:100%;rn font-weight:bold;rn line-height:1.5em;rn padding:0;rn margin:0;rn border:0;rn text-align:center;rn font-size:1em;rn tbackground:#F6E463;rn}rn.o-info div {rn background:#F5F5F5;rn position:absolute;rn right:1.5em;rn bottom:1.5em;rn box-shadow:0 0 10px rgba(0,0,0,.5);rn padding:20px;rn font-size:12px;rn line-height:1.3;rn display:none;rn width:300px;rn border-radius:7px 7px 0 7pxrn}rn.o-info div a {rn text-decoration:underline;rn color:#005776;rn}rn }rnrnrnrnrnrn rn rn rn Premium Digital Access
starting at 99u00a2 rn trn SUBSCRIBErn Already a subscriber? Log in.rn rn All Star Tribune readers without a Digital Access subscription are given a limited number of complimentary articles every 30 days. Once the article limit is reached we ask readers to purchase a subscription including Digital Access to continue reading. Digital Access is included in all multi-day paper home delivery, Sunday + Digital, and Premium Digital Access subscriptions. After the 1 month Premium Digital Access introductory period you will be charged at a rate of $14.99 per month. You can see all subscription options or login to an existing subscription herern rn ?rn rn rn rn rnrn"},"start":""},{"id":"nag","count":7,"action":"lightbox","mute":true,"action_config":{"height":null,"width":"630px","redirect_on_close":null,"template":"{% extends "shell" %}rnrn{% block substyles %}rnrn .nag {rn padding:0;rn }rn .nag-inner {rn padding:0 20px 50px;rn }rn .nag img {rn width:auto;rn margin:0 auto;rn }rn .nag h1 {rn margin-top:-20px;rn text-transform:uppercase;rn color:#61bf1a;rn text-align:center;rn font:normal 26px/1 'Popular bold', serif;rn }rn .nag h2 {rn font:bold 28px/1 'Benton Sans', sans-serif;rn font-style:italic;rn text-align:center;rn }rn .nag-status {rn text-align:left;rn background:#f5f5f5 url("{{ static_url('img-icon-warning.png') }}") 12px 10px no-repeat;rn padding:12px 35px 10px;rn margin-bottom:65px;rn }rn .nag-status p {rn display:inline-block;rn margin-bottom:0;rn font:normal 14px/1 'Benton Sans', sans-serif;rn font-style:italic;rn }rn .nag-status p:first-child {rn color:#ff8200;rn font-weight:bold;rn }rn .nag-status p:last-child {rn color:#ccc;rn float:right;rn }rn .nag-status .btn-link {rn color:#61bf1a;rn }rn .nag-divider {rn border-top:1px solid #e7e7e7;rn text-align:center;rn width:100%;rn max-width:500px;rn margin:40px auto 20px;rn }rn .nag-logo {rn display:inline-block;rn background:#fff;rn padding:10px;rn margin-top:-24px;rn }rn .nag-btn {rn display:block;rn font-size:24px;rn padding:20px;rn border-radius:5px;rn margin:20px auto 0;rn }rn .log-in {rn margin:-40px auto 30px;rn max-width:400px;rn }rnrn{% endblock %}rnrn{% block page %}rn{#rnrn{{ limit - count - 1 }}rnrn{{ form.flow_form_open({nextAction: 'firstSlide'}, null, null, '_top') }}rn {{ form.btn('Save Now') }}rn{{ form.flow_form_close() }}rnrnrn {{ form.get_general_error_messages(['authenticate']) }}rn {{ form.flow_form_open({nextAction: 'login'}, ['authenticate'], 'login-form', '_top') }}rn rn {{ form.login }}rn {{ form.flow_form_close() }}rnrnrnKeep reading rnu2022 Log inrnrnrnrn#}rnrn rn

You have {{ limit - count - 1 }} articles leftrn

rn Keep readingrn u00a0u00a0u2022u00a0u00a0rn Log inrn rn rn rn rn {{ form.get_general_error_messages(['authenticate']) }}rn {{ form.flow_form_open({nextAction: 'login'}, ['authenticate'], 'login-form', '_top') }}rn rn {{ form.login }}rn {{ form.flow_form_close() }}rn rn rn Over 70% off!rn rn rn rn rn rn 99u00a2 for first 4 weeksrn {{ form.flow_form_open({nextAction: 'firstSlide'}, null, null, '_top') }}rn {{ form.button('Save Now', 'btn nag-btn') }}rn {{ form.flow_form_close() }}rn rnrn{% endblock %}rnrn{% block last %}rn{{ parent() }}rnrn{% endblock %}"},"start":""},{"id":"x","count":4,"action":"ignore","mute":true,"action_config":false,"start":""},{"id":"multi-start","count":3,"action":"fly_in","mute":true,"action_config":{"location":"bottom_left","slide_direction":"bottom","group_id":null,"display_delay":"0","collapse_delay":"10","template":", *, *:before, *:after {rn box-sizing:border-box;rn -moz-box-sizing:border-box;rn -webkit-box-sizing:border-box;rn box-sizing:border-box;rn -webkit-text-size-adjust:none;rn margin:0;rn padding:0;rn} {rn position:relative;rn width:300px;rn background:#484848;rn box-shadow:0 0 10px rgba(0,0,0,.3);rn} {rn width:300px;rn height:70px;rn} {rn background:#333333 url("") center center no-repeat;rn width:300px;rn height:70px;rn cursor:pointer;rn} {rn position:absolute;rn top:0;rn right:0;rn height:20px;rn width:20px;rn display:block;rn color:#FFF;rn font-size:20px;rn line-height:1;rn text-decoration:none;rn cursor:pointer;rn text-align:center;rn} {rn color:#E0E0E0;rn} {rn text-align:center;rn} p {rn color:white;rn font:bold 14px/1 'Benton Sans', sans-serif;rn text-transform:uppercase;rn margin:30px 0 7px 0;rn text-align:center;rn font-style:italic;rn} h2 {rn color:#fff;rn font:bold 25px/1 'Benton Sans', sans-serif;rn text-align:center;rn font-style:italic;rn} h2 span {rn color: #A4A4A4;rn text-decoration:line-through;rn} {rn color:white;rn background:#61bf1a;rn font-family:"Benton Sans",Helvetica,Arial,sans-serif;rn font-weight:bold;rn line-height:1;rn text-decoration:none;rn text-transform:uppercase;rn border:none;rn -webkit-appearance:none;rn cursor:pointer;rn padding:15px 0 12px;rn display:block;rn margin:10px auto 30px;rn width:130px;rn border-radius:5px;rn font-size:16px;rn} {rn background:#333 url("") center center no-repeat;rn height:35px;rn}rnrnrn rn rn u00d7rn rn rn

From justrn $3.79 99u00a2 a weekrn Save nowrn rn rn"},"start":""}]};

Star Tribune

Source link

You May Also Like

About the Author: Star Tribune

Leave a Reply

Your email address will not be published. Required fields are marked *

The maximum upload file size: 10 MB.
You can upload: image, audio, video, document, spreadsheet, interactive, other.
Links to YouTube, Facebook, Twitter and other services inserted in the comment text will be automatically embedded.