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. 6

CONOP Overview

Security Personnel

Sample Facilitators

Specimen Collectors

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