COVID-19 Resource Center
The Harrison School of Pharmacy's Division of Clinical Affairs and Outreach has compiled resources for pharmacists and clinicians. Below you will find a PDF listing of approved test kits as well as answers to common questions and best practices.
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COVID-19 Diagnostic Testing Topics
On April 8, 2020, the U.S. Department of Health & Human Services, Office of the Assistant Secretary for Health published a letter entitled “Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity under the PREP Act [PDF].” This document provided guidance authorizing licensed pharmacists to order and administer COVID-19 tests. This includes serology tests that the U.S. Food and Drug Administration (FDA) has authorized for use. This guidance provides pharmacists liability immunity associated with ordering, administering these FDA-approved tests. This document only addresses liability. It does not address billing and reimbursement for COVID-19 testing conducted by pharmacists.
Following the publication of this HHS guidance, twelve national organizations sent a letter to congress requesting immediate support to pass legislation that would grant emergency provider status to pharmacists under Medicare Part B. The letter, which can be found here, emphasized the importance of expanding accessibility to Medicare beneficiaries who are at greatest risk of COVID-19 mortality.
A list of COVID-19 tests that have received FDA approval through the issuance of an Emergency Use Authorization (EUA) can be found on the FDA’s EUA website. This site includes EUAs not only for COVID-19 diagnostic tests, but all COVID-19 technology and supplies.
HSOP’s Division of Clinical Affairs and Outreach is closely monitoring developments in this area and are updating a list of diagnostic tests that have received FDA approval and are viable options for use in the ambulatory care or community pharmacy settings. This list can be found here [PDF].
The setting in which an EUA test may be used are described in its “Letter of Authorization.” The FDA implies that SAR-COV tests that are authorized under an EUA for point of care use are deemed CLIA waived for use in patient care settings operating under a CLIA Certificate of Waiver or Certificate of Compliance.
It is noted that point of care includes setting such as hospitals, physicians' offices, urgent care, outpatient clinics, and temporary patient care settings as long as personnel are trained and are operating under a CLIA Certificate of Waiver or Certificate of Compliance. Information on how to obtain a CLIA Certificate of Waiver may be found here.
If the practice setting does not have an existing CLIA Certificate of Waiver, then this must be obtained before any COVID-19 testing can be done. This process can take time, so it imperative to start this application process now, in order to avoid any delays in being able to implement COVID-19 testing.
Please follow the procedures outlined by your healthcare facility for donning and doffing PPE. If you do not have policies and procedures in place, then the CDC has provided recommendations here. Please review and follow.
- Body Cover: The CDC provides detailed guidance on the type of gowns or coveralls that can be used in patient care activities. Please review these CDC documents to ensure that the best PPE is selected for your COVID-19 diagnostic testing activities.
- Gowns: There are several potential benefits to using gowns. Healthcare providers are often more familiar with gowns, and therefore might be more comfortable with their use. Gowns are easier to put on (don) and take off (doff). Gowns provide more ventilation and may be more comfortable for some healthcare providers. However, gowns do not provide continuous whole-body protection.
- Coveralls: Coveralls typically provide 360-degree, full-body protection (in some cases, even the head and feet as well). Coveralls are more difficult to don and doff. They can be hot due to less ventilation.
- Masks or Respirators: Clinicians should wear an N-95 respirator while conducting COVID-19 testing. Please review the CDC’s website to learn more about face masks and respirators that provide respiratory protection.
- Eye Protection: Safety glasses, goggles, or face shields add additional protection for the eyes. The face shield can protect the eyes and face and adds an extra layer of protection for the respirators / masks. Glasses, goggles, and face shields should be cleaned and disinfected between uses (as soon as removed). Disposable eye protection that is reused should be assigned to one health care provider. Please review the CDC’s website to learn more about eye and face protection.
- Gloves: The CDC recommends the use of nonsterile, disposable patient examination gloves that are typically used for routine care in patient care settings. Gloves should be removed and hands sanitized after each patient.
Optimizing PPE: The CDC has provided guidance on how to optimize PPE.
Supplies needed to perform COVID-19 testing may vary depending on the type of test that is being conducted and the manufacturer’s requirements for the specific test that is being used. The package insert for the specific test should be carefully read and followed, and all required testing supplies will be outlined in this document.
Regardless of the type of test being conducted the following items will be required to ensure the safety of the health care provider, other staff, and the patient:
- Appropriate personal protective equipment (PPE)
- Hand sanitizer
- 70% isopropyl alcohol (for cleaning surfaces)
- Biohazardous waste red bag(s)
- Sharps container(s)
- Trash can(s)paper towels
- Writing pens
The following is a summary of the general requirements for each type of sample collection method (note: these may vary depending on the specific diagnostic test being used).
For tests requiring venipuncture:
- Evacuated collection tubes (tubes specific to test specifications)
- Appropriate needles for drawing blood
- Alcohol swabs for skin disinfection
- Laboratory specimen labels
For tests using fingerstick samples:
- Alcohol swabs
- Cotton balls
- Single-use lancets (preferably retractable safety lancets)
- Blood collection device (capillary tube or other device)
For tests using mucosal swab collections, supplies may include:
- Test tubes or collection devices
- Viral transport media
- Laboratory specimen labels
- Biohazard transport bags
The CDC has developed guidance for evaluating and testing patients for COVID-19. Guidance is provided for each of the 5 categories of people for nucleic acid and antigen testing.
- Individuals with signs or symptoms of COVID-19
- Asymptomatic individuals with recent known or suspected exposure to SARS-CoV-2 to control transmission
- Asymptomatic individuals without known or suspected exposure to SARS-CoV-2 for early identification in special settings
- Testing to determine resolution of infection
- Public health surveillance for SARS-CoV-2
Consistent with the CDC’s updated guidelines, certain asymptomatic people can now be tested by the Alabama Bureau of Clinical Laboratories. These groups include:
- Residents of long-term care facilities
- Residents of congregate housing settings such as shelters
- Persons with underlying medical conditions or disability who are at high risk of complications
- Other asymptomatic individuals approved by the state or local health department on a case-by-case basis
Those who do not meet these criteria may have testing done by other commercial or clinical laboratories.
It is very important to collect mucus specimens correctly. If the amount of sample is insufficient or if the sample collection is not performed correctly, the test will not process (error message stating insufficient sample) or may lead to inaccurate results. The sensitivity and specificity of the tests are performed using appropriate sample collection procedures. Therefore, it is imperative that any clinician performing a test that requires nasopharyngeal sample collection is trained on the correct procedures.Due to the importance of performing this correctly, the New England Journal of Medicine published an article and video to provide guidance on how to accurately collect a nasopharyngeal swab specimen.
An emergency rule was passed on March 6, 2020 that placed SARS-CoV-2 on the list of notifiable diseases for 120 days. This means by law, healthcare providers and labs MUST notify the state’s public health department within 4 hours of a presumptive case. Within Alabama, the Alabama Department of Public Health (ADPH) must be notified immediately of positive test results.
For our state, ADPH requires that all test results (positive and negative) from COVID-19 tests must be reported to the Alabama Department of Public Health.” This is required by law. Health care providers should use the ADPH’s “Novel Coronavirus Report Form” to report the results of ALL COVID-19 tests conducted.
The Families First Coronavirus Response Act (FFCRA) and Coronavirus Aid, Relief, and Economic Security Act (CARES Act) were enacted in March. The FFCRA requires plans and insurers to provide coverage of certain diagnostic testing and services related to COVID-19 to beneficiaries without cost-sharing requirements or prior authorizations. The CARES Act amended section 6001 of the FFCRA to include a broader range of diagnostic items. Section 4202 of the CARES Act made statements regarding reimbursement rates which can be found here. However, neither act uses terminology that includes pharmacist as providers.
In accordance with the CARES Act, numerous health plans including Blue Cross and Blue Shield of Alabama and Aetna are covering medically necessary diagnostic tests that meet CDC guidelines with no cost to members where it is not covered by Public Health Services. Statements released by these health plans currently do not address reimbursement rates or whether pharmacists or pharmacies will be able to bill for services rendered.
If the pharmacy is not able to submit COVID-19 test claims through the pharmacy’s software, the patient may pay out-of-pocket and submit a claim to their insurance for reimbursement.
Polymerase Chain Reaction (PCR) tests identify the presence of the virus to determine if the patient has an active infection. This test is helpful to identify individuals who have an active infection, may require medical care, and are contagious to other people. If a person’s PCR test is negative, this gives no indication of previous exposure to the virus (or lack of exposure) and no information regarding possible immunity.
Serological testing identifies the presence of antibodies to determine if the patient had an infection in the past. Antibodies are formed by the immune system to fight off the infection. Serology tests may look for IgM, IgG or both. IgM appears first, within 1-2 weeks of infection, and is gone from the body after a few weeks. IgG takes longer to appear but can be present in the body for years. This test is helpful to identify people who have been infected previously, even if they were asymptomatic, and possibly have immunity to the specific virus. This information can then be used to make decisions regarding returning to work, plasma donation, and what percentage of the population was exposed to the virus. If the patient has just been exposed to the virus, before the 1-2 weeks needed to develop IgM antibodies, they may test negative despite active infection.
Sensitivity is the ability of a test to identify patients with the disease. A test with 100% sensitivity correctly identifies all patients with the disease (true positive). If a test’s sensitivity is less than 100%, some people with the disease will go undetected (false negative).
Specificity is the ability of a test to correctly identify patients without the disease. A test with 100% specificity correctly identifies all patients without the disease (true negative). If a test’s specificity is less than 100%, some people without the disease will test positive (false positive).
COVID-19 References and Resources for Pharmacists and Clinicians
Last Updated: June 29, 2020