Diagnostic TestingTypes of Specimen Collection The type of specimen collected is dependent upon the type of test being administered. Upper respiratory specimens are recommended by the CDC for initial diagnostic testing. Lower respiratory specimens (sputum) can be considered in patients who have a productive cough. CDC Interim Guidelines for Collecting and Handling Clinical Specimens for COVID-19 Testing: CDC Specimen Collection Information: Nasopharyngeal and oropharyngeal: Sputum cough/suction: Deep nasal collection:
What is Observed Self-Collection?
Using this method, the CDC recommends using standard precautions when the provider supervising self collection is maintaining a social distance of 6 feet or more. By using this method and implementing social distancing, PPE can be preserved for other uses. The minimum PPE recommended with this type of collection include gloves and some type of face covering. Link to standard precaution information and guidelines for specimen collection:
Potential Lab Partners and Point of Care Platforms
Potential lab partners include Mako Laboratories, Quest Diagnostics, LabCorp, and BioReference Laboratories. This list is not comprehensive.
It is recommended that pharmacies check with their existing wholesale partners for any point of care needs. If your wholesaler does not provide something that your pharmacy requires for testing, other wholesale partnerships that may offer point of care supplies include Mutual Drug, Smith Drug, McKesson, and Cardinal Health. This list is not comprehensive.
Recommendations for Supplies, PPE, and Equipment
Donning PPE: Doffing PPE: CDC PPE Burn Rate Calculator: NCDHHS asks that every effort is made to obtain PPE through regular supply chains. However, if there is trouble obtaining necessary PPE, a request can be submitted through NCDHHS at the following link: NCDHHS also realizes that in order to keep up with testing requirements, testing supplies are in constant demand. If your facility is in need of testing supplies, visit the following link for more information about how to request:
Safety Protocol What to Tell Patients Prior to Testing
*see interpreting results section
Where and How Testing Will Be Conducted Many pharmacies are conducting COVID-19 testing in drive-throughs or in a designated area of the pharmacy parking lot. Testing areas outside of the pharmacy are convenient for patients that are being tested and are safer for patients who need to come to the pharmacy for other purposes. Most specimens can be collected while the patient remains in their car. NCDHHS suggests that all testing sites allow for a walk-up option for patients who may not have transportation. Tests may be performed by trained personnel or by using the observed self-collection model. If the specimen is self-collected by the patient, ensure the patient is instructed on how to properly obtain the specimen.
How to Protect Employees and Other Patients To protect pharmacy employees and other patients, ensure that current CDC guidelines for healthcare personnel PPPE use are checked frequently and adhered to. Appropriate signage should be utilized to maintain physical distancing when appropriate and to guide patients to the designated testing areas. Employees must wear appropriate PPE and limit contact with patients who have a suspected or confirmed COVID-19 infection. Refer to the specimen collection section for information on safe collection practices. For patients that are suspected to have COVID-19, employees should implement the CDC’s recommendations for infection prevention and control practices. Current CDC guidance can be found here: NCDHHS provider guidance:
Patient Checklist When Should Patients Get Tested? Testing recommendations are dependent upon patient specific factors such as presence of symptoms, potential exposure, and external requirements (work, travel, school, etc.). Up to date recommendations regarding whether to receive COVID-19 testing can be found through either the CDC or NCDHHS:
Triage Steps
(https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html)
Testing Steps Let patients know where testing will take place at your pharmacy. Once a patient is at your pharmacy for testing, they should wear a facemask and remain in their car to reduce the risk of exposure. Instruct patients to follow all signage and directions at the testing site. Discuss a clear plan to report results to each patient. Let them know what current recommendations are regarding quarantine and isolation while awaiting test results and in the event of a positive result. Up to date information on these recommendations from the CDC can be found here: Example of provider checklists for reference: Example of pharmacy checklist for triage:
Interpreting Results
(https://www.cdc.gov/coronavirus/2019-ncov/testing/diagnostic-testing.html)
Reporting Results
If a pharmacy is considering serving or preparing to serve as a specimen collection site, they are advised to discuss reporting with the partner laboratory conducting the testing as they will likely handle any necessary reporting. Aside from reporting to health departments, the Statewide Standing Order for COVID-19 Diagnostic Testing also requires COVID-19 test results to be reported to the patient and the patient’s health care provider. For more information regarding reporting, please see the NCDHHS website: (https://www.cdc.gov/coronavirus/2019-ncov/lab/reporting-lab-data.html)(https://covid19.ncdhhs.gov/dashboard/about-data) (https://covid19.ncdhhs.gov/media/456/download)
Documentation
It is recommended that protocols for documentation and record-keeping of viral testing can be conducted in the same way that pharmacies currently handle documentation for vaccinations. The following is a non-exhaustive list for things that should be documented and/or the pharmacy should consider documenting: consent form for the test, when the sample is collected, sent, and received by the lab if applicable, the result of the test, when and how the patient is notified, and lastly, how the conversation went with the patient. (https://www.hhs.gov/sites/default/files/hipaa-and-covid-19-limited-hipaa-waiver-bulletin-508.pdf)
Patient Information and Education What the Test Does
When the Results Might Be Ready The time it takes to receive test results can vary depending on the test manufacturer. Most of the rapid diagnostic point of care tests authorized by the FDA can provide results in less than an hour.
How to Get Results Pharmacies administering COVID-19 tests will be responsible for presenting patients with their results. Provide patients with the contact information for your pharmacy and instruct them to speak with a pharmacist for their results.
Interpreting Results
What Actions to Take After Getting Results If a patient has been diagnosed with COVID-19 (i.e. received a positive result from a diagnostic test) and does not require hospitalization, they should stay at home unless they require medical care. In the event that they do need to leave their home for medical care, patients should avoid using public transportation and going to non-medical public places, such as grocery stores or gas stations. While at home, patients should self-isolate by staying in a room separate from others who live there. If they must be in a shared living space at any time, proper social distancing and mask wearing should be utilized. Efforts should be made to sanitize all shared areas. Advise patients to take care of themselves by getting plenty of rest and drinking fluids. Patients should stay in touch with their doctor while monitoring their symptoms. Resources on managing COVID-19 infection for both the patient and the caregiver can be found here:
Quarantine and Isolation Information Quarantine refers to the strategy of preventing transmission after a known exposure to someone with COVID-19. Isolation refers to the strategy of preventing transmission from someone with known or suspected COVID-19 infection to someone without an infection. Specific up to date recommendations on when, how, and with whom to utilize these strategies can be found on the CDC website: |