New York State Hepatitis C Rapid Testing Program - Quality Assurance: Staff Training

NYS Hepatitis C Testing Program Implementation Guide Home Page

What Training is Required for Enrollment in the New York State Hepatitis C Virus Testing Program?

The New York State Hepatitis C Virus Testing Program (NYS HCV TP) provides resources to ensure that staff receive initial and routine competency training.  All staff performing HCV rapid antibody testing must receive training on both the HCV Rapid Test device and general HCV education before implementing HCV rapid antibody testing.  Training must be documented for each staff member conducting testing at the program.  Before staff are permitted to perform an HCV rapid antibody test on their own, their ability to conduct and interpret the test and control results must be demonstrated and documented. 

HCV Rapid Antibody Test Device Training

Training should be provided by a qualified person (e.g., experienced co-worker, facility expert, or outside consultant) with knowledge of how to perform the test and the ability to evaluate the effectiveness of the training (i.e., does staff understand how to perform the test and are they performing the test correctly).  Recommendations for device training include the following: (OraQuick HCV Implementation Guide, pgs. 57-59)

For the Trainer

  • Provides a step by step demonstration of how the specimen is collected and the test is performed;
  • Observes how the trainee collects and performs the test and provides feedback and additional instruction to ensure accurate and reliable test results;
  • Documents in writing available for the department’s review that the training has been completed by the trainee;
  • Evaluates that the trainee has performed the test per the package insert; and,
  • Educates how to identify invalid results and/or test kit or device problems.

For the Trainee

  • Reads the package insert or device user’s manual;
  • Observes the trainer demonstrating how the test is performed;
  • Performs the test per the manufacturer’s package insert while the trainer observes; and,
  • Correctly interprets the test result.

NYS HCV Testing Program staff will arrange device training through OraSure Technologies, Inc., for all participating programs.  Laboratory directors and/or their designees are responsible for attesting to staffs’ ability to conduct the OraQuick® HCV Rapid Antibody Test following this training. Contact information for OraSure Technologies will be provided as part of the enrollment process. 

General HCV Training

Prior to testing clients, staff are required to attend a NYS HCV Testing Program-approved introductory training on hepatitis C with content that includes delivering appropriate counseling messages.  Please see links below to review available training options and to register.  Other options for staff training may be permitted, but alternate arrangements must be approved by the NYS HCV Testing Program.

It is important when conducting testing and linking individuals to care, that testers provide culturally competent services.  Cultural competence may apply to a variety of cultures—people who inject drugs, baby boomers, persons of color, immigrant populations, homeless, and youth.  Program staff should work to provide a welcoming and safe environment where clients feel comfortable accessing services.  Testing staff should have the opportunity to learn respectful and responsive ways to approach different populations, as well as how to successfully address barriers to linking individuals to care.

Trainings should adapt from year to year to address current populations seeking hepatitis C testing.  Cultural competency training opportunities and resources for non-clinical staff are available through AIDS Institute (AI) at https://www.hivtrainingny.org/. 

Who Can Conduct an HCV Rapid Antibody Test?

The OraQuick® HCV Rapid Antibody Test must be conducted in compliance with the manufacturer’s product insert instructions.  There are no specific federal or state educational requirements concerning who can perform a waived test.  It is recommended that the individuals have a high school education or its equivalent and that the following qualities be considered when selecting personnel to perform rapid testing: (OraQuick HCV Implementation Guide, pg. 57)

  • Sincerity and Commitment - A dedication to perform testing according to defined procedures.
  • Literacy - The ability of read instructions and record results is critical.
  • Organizational Skills - If test volume is high and the individual performing testing is doing several tests or managing several other tasks simultaneously, organizational skills can be even more critical.
  • Decision-Making Skills - Rapid testing personnel should be able to interpret results and recognize and handle problems that might come up.
  • Communication Skills - If the person performing the rapid test is also the person who shares results or other information with the person being tested, being able to communicate clearly is important.
  • Quality Assurance - Testing activities are routinely monitored and evaluated for compliance with NYS Clinical Laboratory Evaluation Program (CLEP) guidelines.

Are there Annual Training Requirements for the New York State Hepatitis C Virus Testing Program?

Competency assessments of the following should be conducted routinely, and no less than annually as directed by the OraQuick HCV Implementation Guide.

  • New York State Standard Practices in Laboratory Medicine;
  • Conducting and interpreting the HCV rapid antibody test and controls;
  • Proper specimen collection, handling, processing and shipping for HCV RNA testing (if applicable);
  • Control of Bloodborne Pathogens:
    • Handling hazardous waste;
    • Cleaning and disinfecting work areas and equipment;
    • Selecting and using personal protective equipment; and
    • Exposure Control Plan;
  • Identifying resource person (e.g., staff supervisor, Laboratory Director) who is available (regardless of testing location) for program questions; and
  • Location of telephone numbers for manufacturer’s technical assistance.

Copies of staff competency assessments should be retained with other Limited Service Laboratory (LSL) documentation and included in the laboratory director’s annual review.  Systems and processes for addressing training needs related to identified knowledge deficits, staff orientation, changes to laboratory testing protocols and processes, and new developments in the field should be in place. 

Additional HCV Training Resources

New York State Hepatitis C Virus Testing Program Technical Assistance

The AIDS Institute (AI), Bureau of Hepatitis Health Care (BHHC), NYS HCV Testing Program staff are available to provide technical assistance.