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COVID-19 Guidance: Community Specimen Collection Site Wisconsin Department of Health Services April 2020

Contents Overview ....................................................................................................................................................... 2

Planning ........................................................................................................................................................ 3

Operations .................................................................................................................................................... 7

Specimen Collection ................................................................................................................................. 8

Tear Down / Decontamination .............................................................................................................. 11

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Overview Basic Elements

Entry / Exit Control manages the volume and pace of individuals entering and exiting the site, making sure that only those who are approved to be tested enter the site, and turning away those who have not received approval for testing.

o Entry Ways should facilitate the screening of individual cars before they are permitted to enter the community testing site.

o Exit Ways will be needed both for patients who have completed their sample collection, 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 Area is where specimens are collected and contaminated waste is disposed of. It should:

o Be covered, but not enclosed, to provide shelter from the elements and adequate air flow; and

o Provide some degree of privacy for patients in their cars, when possible.

Command/Coordination, and Support Area is used for site coordination, Personal Protective Equipment (PPE) and testing supplies stocking, cold storage, resting area, restrooms, and wash stations. This space will probably not be contiguous. For example, the site coordination group, supply stockpiles, and cold storage may be in a building, trailer, or enclosed structure, while the restrooms, wash stations, and resting area should be outdoors.

High-Level Process

Patients who are authorized to receive testing will drive up to a controlled entry point where they will be checked in by intake staff.

Patients who are not authorized to receive testing will be turned away.

Patients will pull forward and crack their window only enough for the specimen to be collected.

The patient will exit the site through a controlled exit.

The specimen will be labeled and put into cold storage.

The specimen collector will doff their gloves and throw them out.

The specimen collector will don a new pair of gloves for the next patient.

The specimen collector will change the face shield at the end of their shift/work rest cycle, or at the end of the day, or if there is any contamination (such as being coughed or sneezed on). Upon doffing, the face shield will be dipped in a disinfection solution and allowed to air dry.

Once the day’s appointments are complete, the site will need to be disassembled and disinfected.

o The specimens will need to be delivered or shipped to the laboratory for testing. o The discarded PPE and testing supplies will need to be disposed of appropriately. o Tents, tables, and other equipment will need to be disinfected.

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Planning Engage Stakeholders Engage the relevant stakeholders in your community at the outset of the planning process. This may include working with county emergency management, public health, local law enforcement, and health care providers on issues such as:

Selecting a suitable location.

Determining an operational plan.

Staffing the specimen collection site.

Establishing referral processes and acceptable documentation of referral for testing, such as a doctor’s order or an order from the local health department.

Designate Site Leadership and Assemble Staff There should be a single person 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. For example, a potential staffing structure may include the following. Leadership

Site Leader

Communications Director/Public Information Officer

Safety Officer

Wisconsin Emergency Management Liaison Operations

Specimen Collection/Facilitation

Specimen Transfer

Medical Tracking and Reporting Planning

Site Layout

Staff Augmentation

Situational Awareness

Resource Unit Leader

Volunteer Management Logistics

Host Site Support/Coordination

Traffic Management

Communications Unit

Food Unit

Medical Unit (for staff)

Security / Law Enforcement Administration

Cost tracking / Accounting

Administrative Support

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Pick a Location Choose a location that:

Is accessible to the population you are trying to serve, but one that is also away from densely populated or heavily used areas.

Can handle a volume of cars greater than the number of tests per day you anticipate providing.

Facilitates traffic management and controlled entry and exit.

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. Anticipate Volume Try to anticipate the volume of specimens that the site will collect each day as you plan the site. You may take the following into consideration:

Size of the community.

Current guidelines on who to test. See Testing Criteria for Patients Under Investigation for DHS guidance on prioritization of testing.

Wisconsin State Laboratory of Hygiene, public, and private laboratory capacities to test specimens.

This guidance provides recommendations for establishing a community specimen collection site that has the potential to be scalable through the addition of multiple specimen collection areas. Develop an Internal and External Communications Plan

Designate a communications director/public information officer

Develop a communications plan that, at a minimum, informs the community about: o The presence and purpose of the specimen collection site; o Where it is located; o Who can get tested; and o How to get authorized for testing.

Develop a plan for media management that takes into consideration Privacy/HIPAA protections for those getting tested:

o Engage local health care providers in your media strategy. o Offer a time for interviews and video footage of the inside of the site to be captured

before the site opens. o Clearly communicate these concerns and restrictions to media outlets in advance.

Multi-channel radios (walkie-talkies) can be used to facilitate communication and coordination throughout the site. Consider designating separate channels for specific functions or tasks. For example:

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.

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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.

Develop Policies and Procedures for Prompt Identification and Isolation of Sick Specimen Collection Site Staff

Inform staff of the signs and symptoms of COVID-19 and develop policies and procedures for staff to report when they are sick or experiencing fever (>100.4°F) AND/OR respiratory symptoms (for example, cough, shortness of breath) and instruct them NOT to come to work if they are sick.

Perform regular screening of staff, including temperature checks, before, after, and during their shift.

Immediately isolate individuals who have signs and/or symptoms of acute respiratory illness. Move potentially infectious people to a location away from staff, patients, and others, such as their vehicle or a designated isolation area until the individual can be removed from the site. The isolation area should have closable doors and be away from the command/coordination and support area. Restrict the number of personnel entering isolation areas.

All illnesses should be reported to the site lead through the established internal communication channels.

Physical Layout The physical layout of the site should allow 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. The patient’s route through the site should be clearly marked and as direct as possible. A command/coordination and support area should be established at least 24 feet away from the patient route and specimen collection area so that it can reasonably be considered uncontaminated. Optional additional specimen collection lanes can be added based on the anticipated volume of patients. Specimen collection sites should also have an alternate entrance through which fire, emergency medical services (EMS), or other personnel can easily enter and exit, if needed. They may also consider designated times and safe areas for the media to have access to. Security should be located adjacent to the controlled entry and exit points as well as patrolling the perimeter, especially if the site is not physically secured with fencing or other barriers. Sites that anticipate a large volume of patients should also consider establishing three separate holding areas to facilitate traffic management. These areas would be used to ensure that a high volume of cars does not back up into the roadway. These holding areas would be for those:

Pending intake – This would serve as an overflow holding area for those who have not yet gone through intake.

Pending specimen collection – This would serve as an overflow holding area inside the site, after intake, but before the specimen collection area.

Contesting being turned away – This would serve as a holding area for those who are not authorized to receive testing and have been turned away, but are not willing to leave the site. This is a location where law enforcement can manage these individuals out of the way of traffic and other patients. This should be located after the intake area, away from the site.

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Figure 1. Physical Layout

Command/Coordination and Support Area

Rest Area Port-o-Potties and

Hand Washing Specimen Packaging

and Cold Storage Additional Supplies

Signage

Intake / Controlled

Entry

Patients authorized for testing

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Specimen Collection

Specimen Collection

Specimen Collection

Equipment Staging Area

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Equipment Staging Area

Equipment Staging Area

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Controlled Exit

Fire and EMS Entry

Security Security

Security Security

Cold Zone

Hot Zone

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Operations Intake Process The patient will have to show identification and provide any other needed paperwork that proves they are authorized to receive testing. There are a number of strategies to facilitate this process without direct patient interaction. For example, have the patient 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. The same process could be used at the controlled exit. 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. Intake staff will:

Confirm the patient’s eligibility to receive testing;

Explain the process, including how the patient will receive their test results; and

Fill out the patient information form, specimen label sticker (first and last name and date of birth), and testing requisition form legibly and using permanent ink, 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.

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.

Patients who are not authorized will be instructed to leave. Those who contest being turned away should be directed to the holding area designated for that purpose and followed up with by law enforcement. Intake staff will change gloves and, if using Tyvek suits or reusable impervious surgical gowns, 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). Personnel Roles and Responsibilities

Intake Team o Consists of two individuals with an additional two-person team available to rotate shifts,

as needed. o Is responsible for verifying that patients are authorized to get tested and registering

them. o Works closely with security to ensure no unauthorized individuals or vehicles enter the

site. o Fills out required paperwork and specimen label stickers before the patient is seen by

the specimen collector.

Security Team o Can be divided into three functions:

Traffic control adjacent to entry and exit points (staffed by law enforcement)

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Perimeter security/roving patrol (staffed by trained volunteers) Community liaisons to meet with those who contest being turned away (staffed

by law enforcement) o The size of the security team is dependent on the characteristics and logistics of the

location. Technical Guidance

Intake and security should wear face shields, N95 respirators, surgical gowns and gloves, and be trained in their proper use. The DHS website contains a number of useful resources.

Equipment

Traffic management materials such as electronic sign-boards, sawhorse, traffic cones, or other barriers

Pop up tent

Table and chairs

Laptop or tablet

Clipboard and pens

Ziplock-type storage bags

Multi-Channel Radio

Patient informational materials 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

Specimen Collection 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 will ensure that the specimen requisition form is filled out completely and correctly with special attention to recording the date and time of collection. 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. All specimen collectors and facilitators 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, if using Tyvek suits or reusable impervious surgical gowns, wipe down their sleeves in-between the 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). 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. Personnel Roles and Responsibilities

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Specimen Collectors

Are ideally nursing staff, who should be trained and validated by Subject Matter Experts (SMEs) on this procedure.

Issues the individual a tissue to clear their nasal passage.

Uses a 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.

Receives the collection tube/swab.

Takes a swab of the patient(s) in car.

Returns the swab back into the tube.

Removes and replaces their gloves and wipes down their sleeves in preparation for next specimen.

Specimen Facilitators

Are ideally nursing staff, who should be trained and validated by SMEs on this procedure.

Labels the tube with patient ID.

Inserts the tube into secondary containment (sample bag).

Verifies the patient ID on tube and form is the same.

Receives the decontamination wipe to disinfect the sample bag (use sponge and bleach water if needed).

Places the sample bag into cooler and notifies the runners.

Removes and replaces their gloves and wipes down their sleeves in preparation for next specimen.

Runners

Are personnel trained and validated by SMEs.

Collects the decontaminated sample bag and ensures the sample ID is the same throughout.

Places the form and sample bag in an envelope, signs the form as chain of custody, and places the envelope in shipping container.

Retrieves the sample and places it in a refrigerator until transport.

Monitors the temperature in the refrigerator to ensure it stays within range. Site Safety

Monitors and directs risk mitigation, infection prevention and control, and workplace safety.

Are professionals specializing in infection prevention and control.

Ensures contamination avoidance between the specimen collector and facilitator.

Provides quality control of specimen collection.

Monitors doffing of gloves and specimen labeling. Technical Guidance Personal Protective Equipment (PPE)

Specimen collectors and specimen facilitators should wear N95 respirators, face shields, surgical gowns, and gloves, and be trained in their proper use. They should change their 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). The DHS website contains a number of useful resources.

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 the hot zone, and be trained in their proper use.

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Specimen Collection (Nasopharyngeal, NP)

Use the flexible shaft NP swab provided to collect the specimen.

Have the patient blow their nose and then check for obstructions.

Tilt the patient’s head back 70 degrees and 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.

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.

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.

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.

Place the already completed laboratories test requisition form into the outside pocket of the specimen bag. Do not enclose it inside the bag with the UTM/VTM tube.

All specimen collectors and facilitators 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).

Specimen Holding

Store specimens refrigerated (2 – 8 °C) until ready to send to the laboratory. Specimens may be held refrigerated for up to 72 hours. Specimens should be delivered to the laboratory as soon as possible, but no later than three days of being collected.

Site Safety will be responsible for monitoring sample collection, packaging, and ensuring samples stay within designated temperature range.

Coolers and remotely controlled refrigeration systems can be used until transportation to a laboratory is available.

Specimen Packaging

Place the specimen vial into the Ziplock-like biohazard specimen bag. The facilitator will wipe sample over-packs with an antimicrobial wipe and place over-pack in a cooler in the equipment staging area.

Ensure that the outer packing box that is supplied with the specimen kit is sealed securely with packaging tape.

Ensure shipper label information for your site 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

Arrange for courier transport of specimens. Make certain that specimens are transported with a frozen ice pack in the transport container that will be sent to the lab. The Wisconsin State Laboratory of Hygiene website has information about packaging, shipping, and courier transport.

Equipment

Specimen collection kits o Tube of Universal or Viral Transport Media (UTM or VTM)

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o Nasopharyngeal swab (Smaller Swab, flexible shaft)

Pop-up tent

Table and chairs

Clipboards

Ziplock-type storage bags

Buckets

Sponges

Multi-channel radio

Large trash bins

Large coolers

Tear Down / Decontamination Process At the end of the day, the community 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. Technical Guidance

Follow CDC guidance for donning and doffing PPE.

To clean and disinfect face shields, adhere to recommended manufacturer instructions for cleaning and disinfection. When manufacturer instructions for cleaning and disinfection are unavailable, such as for single use disposable face shields, consider:

o While wearing gloves, carefully wipe the inside, followed by the outside of the face shield or goggles using a clean cloth saturated with neutral detergent solution or cleaner wipe.

o Carefully wipe the outside of the face shield or goggles using a wipe or clean cloth saturated with an EPA-registered hospital disinfectant solution.

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o Wipe the outside of face shield or goggles with clean water or alcohol to remove any residue.

o Fully dry (air dry or use clean absorbent towels). o Remove gloves and perform hand hygiene.

Additional strategies to optimize the supply of PPE and equipment can be found on CDC’s website, including guidance for the decontamination and reuse of filtering facepiece respirators.

Waste disposal Disposable PPE and other contaminated equipment and supplies can be disposed of in commercially available garbage bags with the opening taped shut. An N95 respirator should be worn until the bag is sealed. Gloves should be worn throughout. 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 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, most common EPA-registered household disinfectants should be effective. 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 (concentration, application method and contact time, etc.).

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