specimen collection sop covid-19 (version 4.0)
TRANSCRIPT
Community-Based
COVID-19 Specimen
Collection SOP
April 2020
Template standard operating procedure for
community-based COVID-19 specimen collection
sites in Wisconsin.
Acronyms
CONOP – Concept of Operation
ECP – Entry Control Point
LNO – Liaison Officer
PPE – Personal Protective Equipment
PAX – Personnel or Passengers
Contents
Contents
Site Characteristics (Per Site) ......... 1
....................................................... 4
Site Considerations ........................ 4
CONOP Overview .......................... 6
................................................... 7
CONOP-Personnel ..................... 7
ECP Operations.............................. 9
Security ................................... 9
Screening ................................ 9
ECP Responsibilities .................... 10
ECP Equipment ............................ 11
Specimen Collection Operations ... 12
Process ................................. 12
Testing Kit Contents .............. 13
Specimen Collection Instructions (Nasopharyngeal) .............................................. 13
Specimen Holding ................. 14
Specimen Packaging ............. 14
Specimen Transport .............. 14
Specimen Collection Responsibilities15
Specimen Collection Equipment ... 16
Pg. 1
Site Characteristics (Per Site)
Planning
Engage stakeholders at outset of planning process; work with county
emergency management, public health, local law enforcement, and health care
providers on issues such as:
o Establishing a location
o Determining an operational plan
o Staffing the specimen collection site
o Establishing referral processes for testing, such as a doctor’s order or
local health department order
There should be a single site coordinator who has overall authority of the
specimen collection site and is responsible for operations. In many cases it
may be appropriate to have a designee from County Emergency Management
in this role. Depending on the size of the operation, it may be necessary to
create a hierarchical structure based on different roles (i.e., site safety,
specimen collection, intake, security) to manage staff in those areas and
report up to the site coordinator. Choose a location that:
o Is accessible, yet out of densely populated or heavily used areas.
o Can handle a volume of cars greater than the number of tests per day
you anticipate providing.
o Facilitates traffic management and controlled entry and exit ways.
o Is large enough to allow for the specimen collection lanes, and the
command/coordination and support areas to all be at least 24 feet
from each other.
Examples of good locations include large, hard surface areas, such as parking
lots or fair grounds. Examples of poor locations include neighborhoods, or
nearby open commercial or industrial facilities.
Setup
Pg. 2
Entry and Exit Control Operations / Screening
o Entry ways should facilitate Initial Screening of individual cars before
they are permitted to enter the drive through testing site. Exit ways will
be needed for both patients who have completed their specimen and
in the intake area where patients who do not have an appointment, do
not have the correct paperwork, or otherwise are unable to be tested
can be turned away without disrupting the flow of traffic.
Specimen Collection and Packaging
o Specimen Collection Area is where specimens are collected and
contaminated waste is disposed of. It should be:
• Covered, but not enclosed, to provide shelter from the
elements and adequate air flow; and
• Provide some degree of privacy for patients in their cars,
when possible.
o Specimen packaging, labeling, and wipe down with disinfectant.
o Storage in temperature-controlled unit (2 – 8 °C) until ready to send
to the laboratory.
Command/Coordination and Support Area
o Area for site coordination, stocking of PPE and testing supplies,
cold storage, restrooms, and wash station.
Throughput of Specimens
Try to anticipate the volume of specimens that the site will collect each day as
you plan the site. Consider the size of the community, current guidelines on
who to test, and laboratory capacity to test specimens.
Hours of Operation: (2 hours for setup, 8 hours of operation)
8:00 AM – 5:00 PM (Depending on healthcare partner guidance)
Shift change every 2-4 hours based on throughput and PPE.
Communications Plan
External Plan to Inform the community about:
o The presence and purpose of the specimen collection site;
o Where it is located;
Pg. 3
o Who can get tested; and
o How to get authorized for testing.
Internal Plan to Facilitate Site Communications Including Use of Multi-
Channel Radios
o Intake Channel – Receives and records identifying and
authorizing information from intake staff.
o Exit Channel – Receives and confirms identifying information
from exit control staff and records that specimen collection
occurred as patients exit the site.
o Security Channel – A dedicated channel for security personnel
to communicate on. Depending on the size of the operation,
you may want to have multiple communications channels.
o Site Coordination Channel – A dedicated channel for site staff
to communicate with leadership and support staff.
Identification and Isolation of Sick Staff
Staff are not to show up to work if they are sick or experiencing fever
(>100.4°F) AND/OR respiratory symptoms (for example, cough,
shortness of breath).
Staff must submit to symptom monitoring, including temperature
checks, at the beginning of their shift, during their rest periods, and at
the end of their shift.
Any staff with a fever or respiratory symptoms are to leave the site
immediately and report their illness via radio, phone, or email to their
supervisor.
Pg. 4
Site Considerations
The physical layout of the site allows for controlled entry and controlled
exit, and the ability to turn away patients who are not authorized for
testing without disrupting the flow of traffic. (Y/N)
The patient’s route through the site is clearly marked and as direct as
possible. (Y/N)
A command/coordination and support area is at least 24 feet away from
the patient route and specimen collection area. (Y/N)
Representative from the healthcare partner is present while
conducting the specimen collection? (Y/N)
Lab capacity confirmed for number of specimens to be generated by
collection site deployment? (Y/N)
Receiving lab notified that specimens will be coming? (Y/N)
Location for specimen collection site vetted by location emergency
manager? (Y/N)
Specimen transport (courier/shipping) plan in place? (Y/N)
Alternate entrance for fire, law enforcement, and emergency medical
services (EMS) is available. (Y/N)
Supplies are on hand for mission (e.g., PPE, swabs, transport media)?
(Y/N)
Logistics of specimen collection site on hand and supplied (e.g.,
restroom facilities, hand-wash stations, traffic cones, alternate staff
entrances, message boards, refrigerator capacity for specimens with
power/back-up power sources)? (Y/N)
Security, traffic flow, media on site, and public affairs guidance
established for specimen collection site? (Y/N)
Law enforcement stationed at the controlled entry and exit points and
security staff available to patrol the perimeter. (Y/N)
Waste disposal plan in place? (Y/N)
Pg. 5
Site is large enough to accommodate separate holding areas for those
pending intake, pending specimen collection, and contesting being
turned away? (Y/N)
Pg. 7
CONOP-Personnel Keep accurate rosters of who is working at the site in the event of any
development of symptoms among staff.
Assumptions:
o PPE – N95 masks or surgical masks, gowns, face shields, and
gloves - Supplied by healthcare partner
o Specimen Collection Kits – swabs, viral transport media, sterile
tubes - Supplied by healthcare partner or requested through
SEOC Logistics
On Site Personnel (30 staff):
1. Entry Control Point :
a. (2) Patient verifiers
b. (1) Vehicle guide
2. Specimen Collection team (one team per lane)
a. (3) Specimen collectors (e.g., medical professional,
nurse/trained healthcare personnel)
b. (3) Specimen facilitator (e.g., nursing staff, DHS clerk, patient
liaison, secretary)
c. (3) Runners
3. Safety/Decontamination/Medical:
a. (2) Site Safety (Trained Safety Officer)
b. (2) Decontamination guides (Trained
safety/healthcare personnel)
c. (1) Healthcare Advanced Practitioner for questions regarding
patients/staff monitoring
4. Command and Control
a. (2) DHS/Public Health/CDC/Local Emergency
Manager (Site Coordinator)
b. (1) LNO
Pg. 8
c. (1) Public Affairs LNO
d. (1) Healthcare Partner Representative
Backup Personnel (8 staff):
1. Specimen Collection
a. (2) Specimen collectors (Medical professional, nurse/trained
healthcare personnel)
b. (2) Specimen facilitators (DHS clerk, patient liaison, secretary)
c. (2) Runners
d. (2) Patient Verifiers/Guides
Off Site:
Liaison at Wisconsin Department of Health Services
Liaison at specimen testing laboratory
Pg. 9
Entry Control Point (ECP) Operations
Security
Local law enforcement/security should be requested for:
Traffic control adjacent to entry and exit points
Perimeter security
Screening
1. The patient will have to show identification and provide any other
needed paperwork that proves they are authorized to receive
testing. Patients will be asked to press their identification and
paperwork against the window. Intake staff can then read their
identifying and authorizing information into the multi-channel radio
for the site coordination staff to record.
2. The patients whose specimens will be collected will be instructed to sit near
a window. If they have to switch seats, they should do so without getting
out of the car, if possible.
3. ECP will work in conjunction with local law enforcement/security to
check IDs and ensure individuals getting tested are on the
approved list.
4. Explain the process, including how the patient will receive their test
results.
5. Fill out the specimen label sticker and patient information form,
and place them in a Ziplock-type storage bag and place it under
the driver’s side windshield wiper for transport to the specimen
collection area.
6. Provide a packet of patient information about quarantine and self-
isolation (including when they can exit quarantine or self-isolation),
when and how they will receive their test results, and general
prevention and hygiene recommendations.
7. A guide will escort each vehicle to the designated lane for specimen
collection.
8. Patients who are not authorized will be instructed to leave. Those who
contest being turned away should be directed to the holding area
Pg. 10
designated for that purpose and followed up with by law enforcement.
9. Intake staff will change gloves and wipe down their sleeves in-between
specimens. Face shields will be changed at breaks, at the end of a shift, or
in the event of contamination (such as being coughed or sneezed on).
ECP Responsibilities
Station 1: Intake
Personnel Roles:
1. Screener 1 (Admin)
a. Verifies patient information and doctor’s order/virtual
appointment notification/control number/etc.
2. Screener 2 (Assessor)
a. Provides document to vehicle providing public health
information from DHS/CDC or patient information
sheet generated by local healthcare partner to
include:
i. How they will receive test results
ii. Quarantine and self-isolation (how-to and when to exit)
iii. General prevention and hygiene recommendations
b. Documents demographic information for patient.
Record unique identifier barcode, site, date, and lane
number.
i. First, Last ; Phone number
ii. Email, Address, License plate
iii. ID, healthcare/first responder badge
iv. Insurance information
Pg. 07
ECP Equipment
Incoming ECP Station:
1. Sandbags – 4 ea.
2. Sign-boards
3. Traffic cones
4. Sawhorse – 1 ea.
5. Table – 1 ea.
6. Clipboard and pens – 1 ea.
7. Radios (multiple channels)– 2 ea.
8. Buckets – 2 ea.
9. Sponges – 2 ea.
10. Chairs – 3 ea.
11. Movable barriers – 2 ea.
12. Pop-up tent
13. Laptop or tablet
14. Zip-lock-type storage bags
15. Information materials
Outgoing ECP Station:
1. Table – 3 ea.
2. Clipboard – 3 ea.
3. Radios (multiple channel) – 1 ea.
4. Buckets – 6 ea.
5. Sponges – 6 ea.
6. Chairs – 3 ea.
7. Movable barriers – 2 ea.
Pg. 10
Specimen Collection Operations
Process
The specimen collector will work as a team with the specimen facilitator. The
specimen facilitator will direct the car to the sampling location and instruct the
patient to roll their window down just far enough to take the sample. The
specimen facilitator ensures the tube is labeled with two patient identifiers and
hands it to the specimen collector to take the sample. The specimen collector
places the swab in the tube of Universal Transport Medium / Viral Transport
Medium (UTM/VTM) and returns it to the facilitator to place in a specimen
transport bag. The facilitator will wipe sample over-packs with an antimicrobial
wipe
and place over-pack in a cooler outside the sampling area to be picked up in
by the runners.
Specimen collectors and specimen facilitators should wear N95 respirators,
face shields, surgical gowns, and gloves, and be trained in their proper use.
All personnel who are required to wear N95 respirators should undergo
medical evaluation and fit testing. They will change gloves and wipe down
their sleeves in-between specimens. For example, if three individuals in a car
are authorized for testing, then the collector and facilitator will change their
gloves and wipe down their sleeves between each specimen collected. Face
shields will be changed at breaks, at the end of a shift, or in the event of
contamination (such as being coughed or sneezed on). Site safety monitors
the specimen collection process to ensure quality control and infection
prevention.
Specimen collectors and facilitators should rotate shifts as directed by PPE
guidance and safety work-rest cycle.
Runners should wear N95 respirators, face shields, surgical gowns, and
gloves while in the hot zone, and be trained in their proper use. Site Safety
should wear N95 respirators, face shields, surgical gowns, and gloves while in
Pg. 10
the hot zone.
Testing Kit Contents
1. (1) - Tube of Universal Transport Media (UTM or VTM)
2. (1) – Nasopharyngeal swab (Smaller Swab, flexible shaft)
Specimen Collection Instructions (Nasopharyngeal)
1. Use the flexible shaft NP swab provided to collect the specimen.
2. Have the patient blow their nose and then check for obstructions.
3. Tilt the patient’s head back 70 degrees & insert the swab into nostril
parallel to the palate (not upwards) until resistance is encountered
or the distance is equivalent to that from nostrils to outer opening of
patient’s ear indicating contact with nasopharynx. Leave swab in
place for several seconds to absorb secretions. Slowly remove the
swab while rotating it.
4. Insert the swab into the tube of UTM/VTM, making certain that the
swab tip is covered by the liquid in the tube. The swab is to remain
in the tube for transport.
5. Plastic shaft NP swab: The swab shaft extends past the top of the
tube. Snap off at the break line on the shaft, allowing the end with
the swab tip to remain in the liquid. The tip of the swab must be
immersed in the liquid.
6. Securely tighten the cap on the UTM/VTM tube and recheck to
make certain it is labeled with two patient identifiers. Insert tube into
specimen transport bag and close bag tightly.
7. Complete a Laboratories test requisition form if required. For test
requested, write “COVID-19" under Comments/Other test
requests. Ensure that all information is legible, complete and
accurate. Place the completed form into the outside pocket of the
specimen bag. Do not enclose it inside the bag with the UTM/VTM
tube.
8. All specimen collectors and facilitators will change gloves and wipe
Pg. 10
down their sleeves in-between specimens. For example, if three
individuals in a car are authorized for testing, then the collector
and facilitator will change their gloves and wipe down their sleeves
between each specimen collected. Face shields will be changed
at breaks, at the end of a shift, or in the event of contamination
(such as being coughed or sneezed on).
Specimen Holding
1. Store specimens refrigerated (2 – 8 °C) until ready to send to the
laboratory. Specimens may be held refrigerated for up to 72 hours.
Specimens must be received at the laboratory within three days of
being collected.
2. Site Safety will be responsible for monitoring sample collection,
packaging, and ensuring samples stay within designated
temperature range.
3. Coolers and remotely controlled refrigeration systems will be used
until transportation to a laboratory is available.
Specimen Packaging
1. Place the Specimen vial into the Ziploc-type bag. Facilitator will wipe
sample over-packs with an antimicrobial wipe and place over-pack in a
cooler outside the equipment sampling area.
2. Ensure that the outer packing box that is supplied with the specimen
kit is sealed securely with packaging tape.
3. Ensure shipper label information for your facility is completed in full and
affixed to the outer package. Contact for questions regarding specimen
collection, packaging, and shipping should be directed to the laboratory
that is receiving the specimen.
Specimen Transport
Courier transport of specimens arranged. Specimens will be transported with
a frozen ice pack in the transport container that will be sent to the lab.
Pg. 10
Specimen Collection Responsibilities
Station 2: Specimen collection and Packaging
Personnel Roles:
1. Specimen Collection:
a. Performed by nursing staff
b. Issue individual tissue to clear nasal passage.
c. Use pen light to check for nasal obstructions. Do not force
swab – if an obstruction is encountered, try the other nostril.
If both nostrils are obstructed, contact on-site medical
provider.
d. Receive collection tube/swab.
e. Take swab of patient(s) in car.
f. Return swab back into tube.
g. Remove outer layer of gloves and prepare for next specimen.
2. Specimen Facilitator:
a. Performed by nursing staff.
b. Label tube with patient ID.
c. Insert tube into secondary containment (sample bag).
d. Verifies patient ID on tube and form is the same.
e. Receive disinfectant to wipe down sample bag (use sponge and
bleach water, as needed).
f. Place sample bag into cooler and notify runners.
g. Remove gloves and disinfect face shields, then prepare for next
specimen.
3. Runner:
a. Volunteers trained and validated by SMEs.
b. Collects decontaminated sample bag to ensure sample
ID is same throughout.
c. Places form and sample bag in envelope, signs form as chain
of custody, places envelope in shipping container.
d. Retrieves sample and places in refrigerator until transport.
Pg. 10
e. Confirms temperature in cooler stays within range.
4. Site Safety
a. Professionals specializing in infection prevention and control.
b. Monitors and directs risk mitigation, infection control, and workplace
safety.
c. Ensures contamination avoidance between collector and facilitator
d. Provides quality control of specimen collection.
e. Monitors doffing of gloves and specimen labeling.
Specimen Collection Equipment
Specimen collection Station:
1. Whiteboards – 3 ea. (lane
designators)
2. Pop up tents – 3 ea.
3. Tables – 3 ea.
4. Clipboards – 3 ea.
5. Buckets – 6 ea.
6. Sponges – 6 ea.
7. Chairs – 9 ea.
8. Sawhorses – 3 ea.
9. Radios (multiple channels)– 3 ea.
10. Large trash bins – 3 ea.
11. Large coolers – 3 ea.
12. Sandbags – 3 ea.
13. Specimen collection kits
Operations Center:
1. Chairs – 3 ea.
2. Table – 1 ea.
3. Radio (multiple channels)– 1 ea.
4. Generator – 1 ea.
5. Whiteboard – 1 ea.
Rest Tent:
1. Tent – 1 ea.
2. Chairs – 4 ea.
3. Whiteboard – 1 ea.
4. Table – 1 ea.
5. Sandbags – 8 ea.
6. Heater – 1 ea.
7. Generator 1 ea.
8. Litter – 2 ea.
9. Medical Response Bag/First Aid Kit– 1
ea.
Pg. 11
Tear Down / Decontamination
Process
At the end of the day, the drive-through specimen collection site should be
disassembled and decontaminated. Pop-up tents, tables, chairs, and other
equipment should be disinfected and stored or removed from the property.
Used PPE, test kit supplies, and other disposables should be safely discarded.
Personnel Roles and Responsibilities
Intake Staff
• Decontaminate the equipment and reusable PPE in their area.
• Discard their disposable PPE.
• Compile and submit intake records.
Specimen Collectors and Facilitators
• Decontaminate the equipment and reusable PPE in their area.
• Tear down and store or remove equipment in their area.
• Discard their disposable PPE and decontaminate reusable PPE.
Runners
• Decontaminate the equipment in the administrative area.
• Discard their disposable PPE.
• Tear down and store or remove equipment in their area.
Site Safety
• Oversee decontamination.
• Remove and dispose of waste.
Waste disposal
Dispose of used PPE and other contaminated equipment and supplies in
garbage bags that are taped shut. Staff should use gloves while handling the
garbage bags.
Cleaning and Disinfecting Hard (Non-porous) Surfaces
Wear disposable gloves when cleaning and disinfecting surfaces. Gloves
should be discarded after each cleaning. If reusable gloves are used, those
gloves should be dedicated for cleaning and disinfection of surfaces for
Pg. 11
COVID-19 and should not be used for other purposes. Consult the
manufacturer’s instructions for cleaning and disinfection products used. Clean
hands immediately after gloves are removed.
If surfaces are dirty, they should be cleaned using a detergent or soap and
water prior to disinfection. For disinfection, use EPA-registered household
disinfectants.
o A list of products that are EPA-approved for use against the virus that
causes COVID-19 is available here. Follow manufacturer’s instructions
for all cleaning and disinfection products for (e.g., concentration,
application method and contact time).
o Additionally, diluted household bleach solutions (at least 1000ppm
sodium hypochlorite) can be used if appropriate for the surface. Follow
manufacturer’s instructions for application, ensuring a contact time of at
least 1 minute, and allowing proper ventilation during and after
application. Check to ensure the product is not past its expiration date.
Never mix household bleach with ammonia or any other cleanser.
Unexpired household bleach will be effective against coronaviruses
when properly diluted.
• Prepare a bleach solution by mixing:
o 5 tablespoons (1/3rd cup) bleach per gallon of water or
o 4 teaspoons bleach per quart of water
Equipment
• Bleach
• Buckets
• Sponges
• Disinfecting wipes
• Soap
• Garbage bags