It seems that a new event disrupts how things function on a daily basis with ever-increasing frequency. Weather emergencies like the floods in Tennessee, fires in California, and Hurricane Ida with its associated flooding, as well as everything related to the COVID-19 pandemic, are teaching us to expect the unexpected.
The time to plan for the unexpected is before it happens. If you operate a laboratory, you do not want to be trying to figure out how to handle an inoperable test system when you are in or close to a crisis because of unforeseen circumstances.
Would you know what to do if:
One of your test systems went down?
The freezer where you store fresh frozen plasma (FFP) failed?
The platelet rotator stopped moving?
The CO2 incubator was at room temperature?
You ran out of testing supplies?
Your Laboratory Information System (LIS) was taken down by ransomware?
Clinical Laboratory Improvement Amendments (CLIA) Standard §493.1251(b)(14) requires that, within the laboratory’s procedure manuals, there must be a description of the course of action to be taken if a test system becomes inoperable.
CLIA defines a test system as all the instrumentation, equipment, reagents, and supplies need to perform an assay or examination.
Standard 06.01.03 details the requirements.
06.01.03 Inoperable Test System
The procedure manual must include the description of the course of action to take if a test system becomes inoperable.
REQUIRED ELEMENTS/ADDITIONAL INFORMATION
Test systems may include chemistry or hematology analyzers, microbiology automated systems, or laboratory information systems (LIS).
Procedures should identify the individual(s), either by name or position, to notify if the LIS goes down or if a system error occurs. If a primary test system is inoperable, the procedure must describe the steps to use backup systems as applicable.
SURVEY PROCEDURE
Document Review
Do the procedures for various test systems include what to do if the system becomes inoperable?
In the absence of a backup system, does the procedure address what the laboratory does to meet patient testing needs?
A common mistake made by laboratory operators is to think only about their instrumentation and to assume that this standard is covered if they have a backup analyzer. This standard goes beyond just having backups for primary analyzers.
When assessing compliance with this standard, the laboratory should review all the testing that it performs and consider all the elements involved in providing the necessary patient care.
Do not forget your LIS. Standard 01.03.04 addresses the LIS requirements.
1.03.04 LIS downtime, testing, reporting, and recovery procedures
The laboratory must have downtime policies/procedures to ensure data integrity and timely reporting of patient results. Procedures cover pre-analytic, analytic, and post-analytic phases of testing. Procedures include verifying recovery of interfaced systems, and replacement or updating data, as necessary.
REQUIRED ELEMENTS/ADDITIONAL INFORMATION
Specific protocols define the activities for all phases of testing during LIS downtime, whether scheduled or unscheduled.
Following any hardware/software failure, the LIS must be checked after restoration of data files to ensure that no alterations have occurred that would affect results for patient care.
SURVEY PROCEDURE
Interview and Document Review
Determine if there have been any hardware/software failures. If so, is there evidence that the laboratory verified the LIS following the failure?
Are procedures in place for downtime activities?
Well-thought-out backup plans can help ensure that when the unexpected happens, as we all know it will, your laboratory is prepared, and the staff know what to do. With good procedures in place, your next incident can be a bump in the road rather than a train wreck.
Updates from the CDC
Emergency Use Authorization for BD Vacutainer Plus Citrate Plasma Tubes
On July 22, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Becton, Dickinson and Company (BD) for its BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), which are sodium citrate blood specimen collection tubes used to collect, transport, and store blood samples for coagulation testing. The device authorized under this EUA is for use in coagulation testing by CLIA-certified laboratories performing non-waived testing to aid in the identification and treatment of coagulopathy in patients, including (but not limited to) patients with known or suspected COVID-19.
STEM at CDC Website Is Live!
To help inspire science, technology, engineering, and mathematics (STEM) learners and build the next generation, the Centers for Disease Control and Prevention (CDC) Center for Surveillance, Epidemiology, and Laboratory Services (CSELS) has launched a new website. The STEM at CDC website features resources for:
Students: comic series, free apps, and more for fun science exploration for K–12.
Teachers: lessons, modules, trainings, and events to enhance classroom learning for K–12.
College Students and Professionals: fellowships, programs, and training to further public health careers.
Career Seekers: opportunities to learn how public health is a STEM profession and where it can lead.
Future Disease Detectives: engaging videos that showcase CDC in action, the CDC Museum Disease Detective camp, and the CDC Science Ambassador Fellowship.
Save the Date
CDC’s 17th International Symposium on Biosafety, titled “Beyond the Pandemic: Building on the Lessons Learned,” will be held Feb 12-16, 2022, at the Crowne Plaza Perimeter Hotel in Atlanta, Georgia.
The CDC’s Division of Laboratory Systems recently published the Introduction to Clinical Laboratory Improvement Amendments of 1988 (CLIA) eLearning course. This course is designed for anyone who has a role associated with clinical laboratory testing, including people who perform tests or support other activities related to the clinical testing process. Learners who complete this basic-level course will acquire knowledge about the CLIA program and the quality standards that are part of CLIA regulations.
SARS-CoV-2 Information: Revoked EUA
On August 16, 2021, the U.S. Food and Drug Administration (FDA) revoked the Emergency Use Authorization (EUA201847) for the Guardant-19 test issued on August 21, 2020, and amended on December 28, 2020. In its August 2 letter, Guardant requested revocation of the Guardant-19 effective July 16, 2021. Additional information can be found at Guardant-19 (Guardant Health, Inc.).
Supply Chain Shortages
There is a temporary shortage in point-of-care (POC) and over-the-counter (OTC) test supplies. To help preserve rapid test kits and supplies and meet test demand, the CDC recommends the use of laboratory-based testing whenever possible.
The federal government continues to monitor the testing supply chain and remains in contact with diagnostic test manufacturers. These companies report strong availability of laboratory instruments, laboratory test kits, and other supplies, along with an increasing supply of POC and OTC tests.
Laboratory directors who want to request assistance in connecting with a diagnostics manufacturer may contact AdvaMedDx at staff@advameddx.org. AdvaMedDx is a division of the Advanced Medical Technology Association (AdvaMed) and represents more than 75 manufacturers of diagnostics tests and instruments.
False Positive Results
On September 17, 2021, the FDA issued a letter to clinical laboratory staff and health care providers about false positive results that can occur with Abbott Molecular Inc.’s Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits.
This letter contains important information, including:
Details on potential false positive results.
Recommendations for clinical laboratory staff and health care professionals.
Actions the FDA is taking.
Instructions for reporting problems with the Alinity m SARS-CoV-2 AMP or Alinity m Resp-4-Plex AMP Kits.
On September 21, 2021, a U.S. government interagency group, the SARS-CoV-2 Interagency Group (SIG), added a new variant classification designated Variants Being Monitored (VBM).
In general, for a variant to be classified as a VBM, laboratory data indicate that antibodies developed during previous infection or vaccination show reduced neutralization activity against the variant or the variant demonstrates reduced susceptibility to FDA-authorized monoclonal antibody treatments. VBM may also include variants that have been associated with more severe disease or increased transmission.
LeadCare Blood Lead Test Recall Expanded Due to Risk of Falsely Low Results
On October 14, 2021, Magellan Diagnostics, Inc. and the FDA issued notifications about the expansion of Magellan Diagnostics’ recall of LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests, which were distributed from October 27, 2020, to August 19, 2021. Additional LeadCare II product lots, including lots previously reported to be unaffected, were recalled due to a significant risk of falsely low results. The use of these devices may cause serious injuries because the devices might underestimate blood lead levels. The FDA has identified this as a Class I recall, the most serious type of recall.
“The Geriatric Toothfairy”: A Case Study in Improving Healthcare Access
In this month’s Beyond the Standard podcast, we look at how one woman’s passion for improving oral health one senior at a time has led to a higher bar for mobile services that improve access for all of us. Listen now to Episode 6: "The Geriatric Toothfairy."
Some content presented in “Did You Know?” may consist of timely or topical articles deemed to be of interest to the provider community. These are presented for informational purposes as a service to our readers. The views, opinions, and positions expressed by the authors are theirs alone and do not necessarily reflect the views, opinions, or positions of ACHC, its related entities, or any employee thereof.
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