COVID-19 Testing Update 5/21/2020 - Current Topics

COVID-19 Testing Update 5/21/2020

The WV BOP is aware of the HHS Advisory Opinion the came out today regarding pharmacist COVID-19 testing.  The WV BOP has worked with WV DHHR Bureau for Public Health and the State Health Officer to provide Guidance with the appropriate contacts and pathways to follow for a pharmacist/pharmacy who decides to undertake the provision of COVID-19 testing at his/her pharmacy.  

On April 8, 2020, the United States Department of Health and Human Services (HHS) published a guidance to authorize licensed pharmacists to order and administer COVID-19 tests, including serology authorized by the Food and Drug Administration (FDA).  A current list of the FDA authorized tests under the Emergency Use Authorization (EUA) to diagnose and respond to public health emergencies are available here under In Vitro Diagnostic EUAs.

The FDA specifies which point-of-care tests for COVID-19 are considered CLIA-waived according to an EUA. As defined, CLIA-waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”  The FDA determines which tests meet these criteria when it reviews the manufacturer’s application for a waiver.

May CLIA-waived tests be performed at a pharmacy in WV?

The long standing position of the WV Board of Pharmacy is that the performance of CLIA-waived tests is within the scope of the practice of pharmacist care provided they are administered in accordance with the FDA’s CLIA requirements.

Who may perform the CLIA-waived tests in WV?

Pharmacists, along with pharmacy interns under the supervision of a pharmacist, may perform CLIA-waived tests.  Training for how to collect the sample and perform the specific CLIA-waived test must be documented per CLIA requirements.

How can a pharmacy obtain a CLIA Certificate of Waiver?

All sites where a pharmacy is performing FDA-authorized COVID-19 testing must have a CLIA certificate for the appropriate type of testing that will be performed.  Refer to the CMS document How to Apply for a CLIA Certificate of Waiver.  The WV Department of Health and Human Resources Office of Laboratory Services is the state agency that will process new CLIA Certificates of Waiver and is processing these applications as they are submitted online. When completing the CLIA Certificate of Waiver application on Page 3, Section VI, Waived Testing, the pharmacy must list the specific test(s) the pharmacy will be performing.  It is necessary to be specific to the level of name of the test/kit and manufacturer (e.g. Abbott ID Now, Quidel Sofia SARS antigen, etc.)

Which of the COVID-19 Tests are CLIA-waived for Point-of-Care testing?

As previously mentioned, the FDA has clarified that when an EUA is granted for a COVID-19 point-of-care test, the test is considered to be CLIA-waived.

Please be aware that there are availability concerns for these tests and the supplies required for testing.  Additionally, be aware that some of these tests recommend the test itself be run in a biosafety cabinet because the well is open and there are concerns for the safety of the individual performing the test.  Be well educated on the test parameters, requirements, and reliability. 

Point-of-care testing that is CLIA-waived by definition does not require a medical order, and can be identified using the following steps:

  1. Access the FDA’s EUA website.
  2. Scroll down to find the “In Vitro Diagnostic EUAs” on the FDA’s website.
  3. Tests that are indicates with a “W” under the “Authorized Setting(s)” section of the list are considered CLIA-waived point-of-care tests.

 

Is a prescriber’s Order Required to Perform a CLIA-waived COVID-19 Test?

No. The point-of-care tests authorized under an EUA are deemed CLIA-waived and do not require a prescriber’s order prior to administration.  However, testing should be performed in accordance with CDC and WV DHHR testing priorities and therefore, patients should be screened for testing.

Pathways for pharmacies to perform COVID-19 tests

There are two possible pathways for a pharmacy to participate in COVID-19 testing in the community.  The process is explained in a detailed checklist and is available here.

Must test results be reported to WV DHHR?

Yes. If the pharmacy is performing the test, then the pharmacy must electronically report the test results to the WVDHHR in accordance with the emergency provisions of 64 CSR 7.

If the pharmacy is only collecting the specimen sample and partnering with a lab that will perform the test,  the pharmacy should only partner with a lab that reports results electronically to WVDHHR in accordance with the emergency provisions of 64 CSR 7.

If a pharmacy is interested in working with a lab that does not electronically report to WVDHHR, they should have the lab contact the WVDHHR, Division of Infectious Disease Epidemiology at 1-800-423-1271 or 304-558-5358 to learn how to get electronic reporting set up.

 

 

Must test results be reported to the Local Health Department?

Positive test results must be immediately reported to the local health department. If the pharmacy is performing the test, it must immediately report all positive test results to the local health department.

If the pharmacy is partnering with a lab, the pharmacist should confirm that the lab will immediately report all positive test results to the local health department. Additionally, the pharmacist must contact the patient’s primary care provider to notify of any test result.  If the pharmacist has questions about reporting he/she should contact the local health department.

How must patients be notified?

The pharmacist must notify all patients of their test results in a timely manner that maintains patient privacy in accordance with state and federal laws and regulations. The local health department will implement contact tracing upon notification of a positive test result.

Is training required for collecting and performing tests?

The pharmacy must ensure that all pharmacists and pharmacy interns have received appropriate training to collect specimen samples and perform COVID-19 tests in a safe an effective manner and document the training.  The pharmacy must adhere completely to the manufacturer’s instructions.

PPE

All COVID-19 testing must be conducted while wearing appropriate PPE.  Guidance for this can be found at the CDC’s website.

Pathways

 

       
       
 
 

Pathway 1

  • Pharmacy has obtained specimen collection kits including specimen swabs and viral transport media.  Pharmacy should work with contracted lab to obtain supplies.

 

Pathway 2:

  • Pharmacy has obtained the point-of-care testing machine and cassettes.
  • Pharmacy has obtained the specimen collection kits.
  • Pharmacy employees have been trained on the testing machine.
 

Checklist

Testing Services

Pathway 1

Pathway 2

  • The licensed pharmacist has been given the authority to order and administer COVID-19 tests by HHS*. Pharmacist could also have a local physician standing order or individual prescription authorizing the test.
  • Pharmacy has contracted with a laboratory for testing that will report results electronically.
  • Pharmacy has an active CLIA Certificate of Waiver

 

Testing Supplies

Pathway 1

Pathway 2

â–¡ Pharmacy has obtained specimen collection kits including specimen swabs and viral transport media.

Pharmacy should work with contracted lab to obtain supplies.

â–¡ Pharmacy has obtained the point-of-care testing machine and cassettes.

â–¡ Pharmacy has obtained the specimen collection kits.

â–¡ Pharmacy employees have been trained on the testing machine.

 

Personal Protective Equipment (PPE)

Both Pathways

Pharmacy will need to able to supply their own PPE.  Public supplies are not currently available.

  • Pharmacy employees have been trained on appropriate PPE use including storage, disposal/recycling, fit testing on N95 respirators.

 

Specimen Collection

Pathway 1

Pathway 2

  • CDC Specimen Collection Guidelines have been reviewed.
  • Pharmacy has received guidance from contracted laboratory on accepted specimen type. 
  • Pharmacy employees are trained on the type of specimen collection.
  • Pharmacy has identified a location to collect specimens and has planned the logistics.

Specimen collection should take place outside the pharmacy building in an open space to minimize exposure to others.

  • Pharmacy has identified a proper method of disposal of specimens and any PPE that may have come in contact with patient.
  • CDC Specimen Collection Guidelines have been reviewed.
  • Pharmacy has reviewed the manufacturer’s instructions and will follow the instructions completely.
  • Pharmacy employees are trained on the type of specimen collection.
  • Pharmacy has identified a location to collect specimens and has planned the logistics.

Specimen collection should take place outside the pharmacy building in an open space to minimize exposure to others.

  • Pharmacy has identified a proper method of disposal of specimens and any PPE that may have come in contact with patient.

 

Testing Priorities

Both Pathways

  • Pharmacy has a triage system in place and will prioritize testing.

Pharmacies should work with local health department to determine local testing needs and should be consistent with CDC and WV DHHR testing priorities.

 

Communication of Results

Both Pathways

  • CDC Management of Patients with Confirmed COVID-19 Guidelines have been reviewed.
  • Pharmacy has a process in place to notify the patient and primary care provider of results.
  • Pharmacy has process in place to refer positive patients to their primary care provider and/or physician writing local standing order for COVID-19 testing.

 

Reporting Results to Local Health Department

Pathway 1

Pathway 2

  • Pharmacy has confirmed that the laboratory will immediately report all positive results to local health department.
  • Pharmacy has a system in place to immediately report all positive results to local health department.

 

Reporting Results to WV DHHR

Pathway 1

Pathway 2

  • Pharmacy has confirmed that the laboratory will electronically report all results to DHHR in accordance with 64 CSR 7.
  • If a pharmacy is interested in working with a lab that does not electronically report to WVDHHR, they should have the lab contact the WVDHHR, Division of Infectious Disease Epidemiology at 1-800-423-1271 or 304-558-5358 to learn how to get electronic reporting set up.
  • Pharmacy will electronically report all results to DHHR in accordance with 64 CSR 7.
  • The pharmacy must contact the WVDHHR, Division of Infectious Disease Epidemiology at 1-800-423-1271 or 304-558-5358 to learn how to get electronic reporting set up.

 

List of ELR Reporting Labs as of 5/1/2020

 

AIT Laboratories

ARUP Laboratories

Beckley Appalachian Regional Hospital

Bioreference Laboratories

Bluefield Regional Medical Center

Boone Memorial Hospital

Cabell Huntington Hospital

Charleston Area Medical Center

Davis & Broaddus/Davis Medical Center

Grafton Hospital

Grant Memorial Hospital

Greenbrier Valley Medical Center

Hampshire Memorial Hospital

Jackson General

LABCORP

Logan (Life Point)

Mako Medical Lab

Marietta Memorial Hospital Lab

Mayo Laboratories

Minnie Hamilton

Mon Health Medical Center

Montgomery General Hospital

Morgan County Hospital

Plateau Medical Center

Pleasant Valley Hospital

Pocahontas Memorial Hospital

Preston Memorial Hospital

Princeton Community Hospital

PWN Health

Quest Teterboro

Quest Pittsburgh

Quest Chantilly

Quest Wood dale

Quest San Juan Capistrano

Quest Atlanta

Quest Dallas

Quest Erie ACL

Quest Horsham

Quest Lenexa

Quest New England

Quest Seattle

Quest Tampa

Quest West Hills

Q Lab

Raleigh (Life Point)

Roane General Hospital

Saint Frances Hospital

Saint Mary's Hospital

Shenandoah Memorial Hospital

Sistersville General Hospital

Stonewall Jackson Memorial

Summers Appalachian Regional Hospital

Sunrise Medical Lab

Thomas Memorial Hospital

Veterans Association Beckley

Veterans Association Huntington

Valley Health System

War Memorial Hospital

Warren Memorial Hospital

Webster County Memorial Hospital

Weirton Medical Hospital

Welch Community Hospital

Wetzel County Hospital

Wheeling Hospital

Winchester Medical Center

WV Office of Laboratory Services

WVU - Berkeley Medical Center

WVU - United Hospital Center

WVU - Ruby

WVU - Summersville Regional

WVU - Jefferson Medical Center

WVU - Camden Clark

WVU - Reynolds Memorial

WVU - Potomac Valley Hospital

WVU - Braxton Hospital

WVU - St Josephs

Page Updated: 12:00:00 AM