Till extra info turns into accessible, precautions needs to be taken in dealing with specimens which might be suspected or confirmed for SARS-CoV-2. Well timed communication between medical and laboratory workers is important to reduce the chance incurred in dealing with specimens from sufferers with attainable SARS-CoV-2 an infection. Such specimens needs to be labeled accordingly, and the laboratory needs to be alerted to make sure correct specimen dealing with. Common and particular biosafety pointers for dealing with SARS-CoV-2 specimens are supplied beneath. For added info on dealing with SARS-CoV-2 specimens, confer with the Laboratory Regularly Requested Questions.
All laboratories ought to carry out a site-specific and activity-specific threat evaluation to establish and mitigate dangers. Danger assessments and mitigation measures are depending on:
- The procedures carried out
- Identification of the hazards concerned within the course of and/or procedures
- The competency degree of the personnel who carry out the procedures
- The laboratory gear and facility
- The assets accessible
Comply with Normal Precautions when dealing with medical specimens, all of which can comprise probably infectious supplies.
Comply with routine laboratory practices and procedures for decontamination of labor surfaces and administration of laboratory waste.
Routine diagnostic testing of specimens, comparable to the next actions, will be dealt with in a BSL-2 laboratory utilizing Normal Precautions:
- Utilizing automated devices and analyzers
- Processing preliminary samples
- Staining and microscopic evaluation of fastened smears
- Examination of bacterial cultures
- Pathologic examination and processing of formalin-fixed or in any other case inactivated tissues
- Molecular evaluation of extracted nucleic acid preparations
- Ultimate packaging of specimens for transport to diagnostic laboratories for added testing (specimens ought to already be in a sealed, decontaminated major container)
- Utilizing inactivated specimens, comparable to specimens in nucleic acid extraction buffer
- Performing electron microscopic research with glutaraldehyde-fixed grids
The follow of anatomic pathology performs a essential position in figuring out correct illness diagnoses by finding out organ tissues and fluids. Anatomic pathology contains surgical pathology, histotechnology, cytology, and post-mortem.
Dangers related to surgical pathology and a few cytology procedures happen through the manipulation of recent tissue and physique fluids from sufferers who could have an unknown or identified infectious illness, comparable to COVID-19. Dangers are elevated within the surgical grossing room throughout guide specimen dealing with, tissue dissection, and the preparation of frozen sections of tissue utilizing a cryostat. These procedures can lead to percutaneous exposures from punctures or cuts; droplet or aerosol exposures from splashes of blood and physique fluids; and exposures from surfaces contaminated with the virus.
Scientific in addition to non-clinical assist workers want to pay attention to these dangers and supplied with efficient mitigation procedures. See Laboratory Regularly Requested Questions for extra info.
Observe: This steerage does not apply to medical pathology, which entails laboratory testing on affected person specimens, comparable to blood, physique fluids, stool and urine. Scientific pathology makes use of completely different procedures and workflows than these utilized in anatomic pathology, and subsequently the dangers and mitigation controls wanted to guard personnel are completely different. At a minimal, all personnel—whether or not practising anatomic or medical pathology—ought to observe Normal Precautions when dealing with affected person tissues and specimens.
Level-of-Care (POC) exams are supposed to complement laboratory testing, making testing accessible to communities and populations that can’t readily entry laboratory testing, and bolstering testing to rapidly handle rising outbreaks. Examples of potential makes use of for POC devices for COVID-19 diagnostic functions embrace:
- Deployment to rural hospitals or different essential care websites that lack broadly accessible testing.
- Use at public well being division testing websites that carry out CLIA-waived testing for different functions.
- Deployment to long-term care services or correctional establishments.
- Speedy deployment to assist within the investigation of a newly recognized case cluster.
- Placement in laboratories to check high-priority specimens that require a speedy end result.
Regulatory necessities and crucial CLIA documentation must be thought-about when deploying devices to those settings if they don’t seem to be presently performing different POC testing. Testing websites that function a POC diagnostic instrument should have a present Scientific Laboratory Enchancment Amendments of 1988 (CLIA) certificates. Throughout the COVID-19 public well being emergency, the Facilities for Medicare & Medicaid Companies (CMS) will allow a laboratory to increase its current Certificates of Waiver to function a brief COVID-19 testing web site in an off-site location, comparable to a long-term care facility. The momentary COVID-19 testing web site is simply permitted to carry out waived exams, in line with the laboratory’s current certificates, and have to be underneath the route of the present lab director.
Laboratories ought to take into account the next when utilizing POC devices for SARS-CoV-2 diagnostic goal:
- Use the instrument in a location related to a present CLIA certificates.
- Carry out a site-specific and activity-specific threat evaluation to establish and mitigate security dangers.
- Prepare workers on the right use of the instrument and methods to reduce the chance of exposures.
- Comply with Normal Precautions when dealing with medical specimens, together with hand hygiene and the usage of PPE, comparable to laboratory coats or robes, gloves, and eye safety. If wanted, extra precautions can be utilized, comparable to a surgical masks or face defend, or different bodily boundaries, comparable to a splash defend to work behind.
- When utilizing affected person swabs, reduce contamination of the swab stick and wrapper by broadly opening the wrapper previous to inserting the swab again into the wrapper.
- Change gloves after including affected person specimens to the instrument.
- Decontaminate the instrument after every run by utilizing an EPA-approved disinfectant for SARS-CoV-2. Following the producer’s suggestions to be used, comparable to dilution, contact time, and secure dealing with.
For added info, confer with:
Procedures with a excessive probability of producing aerosols or droplets, needs to be completed utilizing both a licensed Class II Organic Security Cupboard (BSC) or extra precautions to supply a barrier between the specimen and personnel. Examples of those extra precautions embrace private protecting gear (PPE), comparable to a surgical masks or face defend, or different bodily boundaries, like a splash defend; centrifuge security cups; and sealed centrifuge rotors to scale back the chance of publicity to laboratory personnel.
Website- and activity-specific biosafety threat assessments needs to be carried out to find out if extra biosafety precautions are warranted primarily based on situational wants, comparable to excessive testing volumes, and the probability to generate infectious droplets and aerosols.
Procedures that focus viruses, comparable to precipitation or membrane filtration, will be carried out in a BSL-2 laboratory with unidirectional airflow and BSL-3 precautions, together with respiratory safety and a chosen space for donning and doffing PPE. The donning and doffing area shouldn’t be within the workspace. Work needs to be carried out in a licensed Class II BSC.
This steerage is meant for less than these laboratories that carry out virus focus procedures, together with wastewater/sewage surveillance testing, and never for public well being or medical diagnostic laboratories that deal with COVID-19 medical specimens or laboratories that carry out tradition and isolation of SARS-CoV-2. Website- and activity-specific biosafety threat assessments needs to be carried out to find out if extra biosafety precautions are warranted primarily based on situational wants, comparable to excessive testing volumes or massive volumes, and the probability to generate infectious droplets and aerosols.
CDC recommends virus isolation in cell tradition, and preliminary characterization of viral brokers recovered in cultures of novel SARS-CoV-2 needs to be performed in a Biosafety Degree 3 (BSL-3) laboratory utilizing BSL-3 practices. To find out applicable biosafety mitigation measures, laboratories ought to carry out an activity-specific biosafety threat evaluation that evaluates laboratory services, personnel and coaching, practices and strategies, security gear, and threat mitigation measures. Biosafety professionals, laboratory administration, and scientific and security specialists needs to be concerned within the threat evaluation course of.
For extra info on threat assessments:
Decontaminate work surfaces and gear with applicable disinfectants by utilizing an EPA-approved disinfectant for SARS-CoV-2exterior icon. Following the producer’s suggestions to be used, comparable to dilution, contact time, and secure dealing with.
Deal with laboratory waste from testing suspected or confirmed COVID-19 affected person specimens as all different biohazardous waste within the laboratory. Presently, there isn’t any proof to recommend that this laboratory waste wants any extra packaging or disinfection procedures
Pack and ship suspected and confirmed SARS-CoV-2 affected person specimens, cultures, or isolates as UN 3373 Organic Substance, Class B, in accordance with the present version of the Worldwide Air Transport Affiliation (IATA) Harmful Items Rulesexterior icon and U.S. Division of Transportation’s (DOT) Transporting Infectious Substances Safelypdf iconexterior icon. Personnel have to be educated to pack and ship in accordance with the laws and in a fashion that corresponds to their function-specific duties.