New York State Hepatitis C Testing Program Requirements - Policies and Procedures

NYS Hepatitis C Testing Program Implementation Guide Home Page

Policy and Procedure Overview

The purpose of this section is to provide guidance for preparing policies and procedures (P&Ps) for conducting hepatitis C virus (HCV) rapid testing using the OraQuick® HCV Rapid Antibody Test.  P&P’s are a requirement for enrollment into the NYS HCV Testing Program.  A sample P&P template is included at the end of the section.  This template should be used as a guide only and modified as needed to reflect testing practices at the program.

Programs are required to provide a copy of their HCV testing P&Ps for review and approval before enrolling in the NYS HCV Testing Program.  These must include laboratory protocols for conducting the OraQuick® HCV Rapid Antibody Test and other required program elements (e.g., referral tracking and data reporting).  At a minimum, P&Ps should include instructions, program guidance and the forms necessary to maintain a quality testing program.  Programs do not need to submit a written protocol to the Wadsworth Center, Clinical Laboratory Evaluation Program (CLEP) for approval. However, an up to date limited service laboratory procedure manual and protocol for conducting the OraQuick® HCV Rapid Antibody Test must be maintained and available at all registered locations.

P&Ps should be read by all new testers and accessible to staff at all testing sites.  Changes to the P&Ps must be communicated to both the testing staff and the laboratory director.  When procedures are no longer used, they should be removed from the manual and retained with a notation of the dates during which they were in service.  The laboratory director is responsible for documenting a review of P&Ps at least annually.

What are the broad categories that should be included in the Hepatitis C Virus (HCV) Testing Program Policies and Procedure (P&Ps) Manual?

The following should be included in the hepatitis C-specific P&P: (Ready? Set? Test! Booklet):

  • Client eligibility for testing;
  • Description of risk assessment for HCV rapid testing;
  • Description of oversight of the testing program including any delegation of   Laboratory Director duties to designated staff;
  • Health Care Provider authorization for testing;
  • Preparing the test and control;
  • Performing the test;
  • Troubleshooting testing problems;
  • Interpreting and reporting test results;
  • Control of Bloodborne Pathogens:
    • Handling hazardous waste;
    • Cleaning and disinfecting work areas and equipment;
    • Selecting and using personal protective equipment;
    • Exposure Control Plan;
  • Performing quality control (QC) procedures;
  • Recording temperatures of refrigerators, storage areas, and testing areas;
  • Keeping inventories and lot numbers of kits and controls;
  • Training new personnel and assessing proficiency on an annual basis;
  • Delivering HCV appropriate pre-and post-test counseling messages;
  • Referring reactive clients to diagnostic testing (HCV RNA) and/or HCV medical care and evaluation;
  • Entering and submitting testing data to the AIDS Institute (AI), Bureau of Hepatitis Health Care; and,
  • Protocols for conducting HCV RNA testing, if applicable.

Is there specific guidance or language recommended for any of the Hepatitis C Virus Testing Program Policies and Procedure Manual categories listed above?

Client Eligibility

The OraQuick® HCV Rapid Antibody Test is Food and Drug Administration (FDA) approved for use on persons who meet the following eligibility criteria:

  • Must not be pregnant;
  • Must have risk factor for HCV or signs or symptoms of HCV; and,
  • Must be at least 15 years of age (In New York State parental consent is required for HCV testing for patients younger than 18 years of age unless patient meets the medical treatment of a minor exception criteria outlined in PHL §2504).

The HCV RNA Dried Blood Spot has no age requirement.

Risk Assessment

New York State Hepatitis C Virus Testing Program. is a high impact testing program, whose purpose is to test those at the highest risk for HCV infection.

Hepatitis C testing, as a part of the New York State Hepatitis C Virus Testing Program., is recommended for those who have ever:

  • Shared needles and/or injection drug use equipment, even once (e.g., water, cotton, cooker, ties, etc.);

Hepatitis C testing for other persons, should be referred to other providers (e.g., primary care physician) for testing. This includes:

  • Universal, one-time screening;
  • Baby-boomer cohort (birthdate 1945-1965);
  • Annual screening for persons who are HIV positive;
  • Annual screening for men who have sex with men;
  • Occupational exposure;
  • Received blood product or transplant prior to 1992;
  • Non-injection drug use and/or shared non-inject drug equipment.

New York State Limited Service Laboratory Protocols

Laboratory Director Responsibilities or Delegation of Responsibilities

In accordance with “NYS Guidance for following Standard Practices in Laboratory Medicine”, the laboratory director or designee is responsible for oversight of all HCV testing program activities, including:

  • Training of staff performing tests and annual evaluation to demonstrate continued ability and knowledge to perform the test (competency assessment);
  • Maintaining an up to date procedure manual for all laboratory tests performed;
  • Making sure all tests are performed as written in the manufacturer’s package insert or device user’s guide;
  • Maintaining completed and accurate records of tests performed; and
  • Complying with other state and federal laws, including reporting of communicable diseases and other public health concerns (e.g. lead testing).

For additional information on NYS LSL laboratory director roles and responsibilities see Program Requirements.

Authorization for Testing

Tests performed by NYS LSLs must be ordered by physicians or other health care providers, such as a nurse practitioners or physician assistants, who are legally authorized (by NYS professional practice law) to use the results of clinical laboratory tests in the practice of their profession.  Authorization for testing must be documented in the program’s policy and procedure document.  Staffing at the program will determine whether standing or patient-specific orders are required.

For additional information on NYS LSL Standards see Program Requirements.

Considerations for Space Where Testing is Performed

HCV rapid antibody testing in clinical and/or nonclinical settings can be done anywhere that the confidentiality of participants can be assured (e.g., private area or room) and where a specimen can be collected per minimal standards as outlined by the Occupational Safety and Health Administration .  The setting must have a flat surface, acceptable lighting, and the ability to maintain temperatures for performing the test in the range recommended by the test manufacturer.  Testing venues proposed at enrollment will be assessed to ensure that they:

  • Target populations at highest risk for hepatitis C virus (HCV);
  • Are safe and appropriate sites for conducting the OraQuick® HCV Rapid Antibody Test; and,
  • Ensure that program resources are being used appropriately.

Specimen Collection and Performing the Hepatitis C Virus Rapid Test

This section of the P&P should include or reference the step by step package insert on how to perform the OraQuick® HCV Rapid Antibody Test.  When using quick reference instructions, ensure that only the most recent package insert for the OraQuick® HCV Rapid Antibody Test is included in the manual.  This section will also include information for staff on preventing exposures to bloodborne pathogens and proper clean-up and disposal of testing materials. For more information, please see Occupational Safety.

Transporting Testing Supplies

Many programs transport HCV rapid antibody test kits and testing supplies off-site to test individuals in venues outside their agency (i.e., Community Screening must be listed on Limited Service Laboratory (LSL) Registration Certificate).  Procedures should be written to indicate how testing supplies are transported to and from off-site testing venues.  Procedures should include information on how kits are packaged and transported, and how temperatures are monitored to ensure product integrity.

Every effort must be made to keep test kits within the appropriate storage range.  It is recommended programs transport kits in an insulated transport bag.  Cooling packs may be necessary to maintain temperature on warmer days.  When temperature ranges outside exceed the storage temperatures, it is recommended that staff consult with their supervisor or Laboratory Director on appropriate transport protocol.

Sample Off-Site Testing Procedure

Environmental Conditions and Quality Control

This section should address both the program’s quality control and quality assurance systems for the OraQuick® HCV Rapid Testing processes.  Quality control makes sure that results generated by the test are correct, while the quality assurance system checks the whole testing process from start to finish.  OraSure Technologies determines required elements of these systems.  Strict adherence to manufacturer guidelines is key to a quality testing program. 

  • Due to the specificity and complexity of this guidance, please see the Quality Assurance Section of this manual for further information.

Staff Training

All program staff performing HCV testing must be fully trained before beginning client testing.  This initial training must be documented for each tester by the supervisor.  Before staff are permitted to perform a HCV rapid antibody test on their own, their ability to conduct and interpret the test and controls must be demonstrated and documented.  The assessment of staff proficiency must be reviewed and documented by a supervisor on a routine basis. 
In addition, all staff must be knowledgeable of HCV and be able to effectively deliver appropriate HCV counseling messages based on the rapid test result and the clients’ reported risk behaviors.  All staff participating in the HCV testing program must be trained in the following (OraQuick HCV Implementation Guide):

  • New York State Standard Practices in Laboratory Medicine;
  • Overview of hepatitis C, including appropriate counseling messages;
  • Conducting and interpreting the HCV Rapid Antibody Test and Controls;
  • For programs enrolled in the HCV RNA testing component proper specimen collection, handling, processing and shipping; and
  • Control of Bloodborne Pathogens:
    • Handling hazardous waste;
    • Cleaning and disinfecting work areas and equipment;
    • Selecting and using personal protective equipment; and,
    • Exposure Control Plan; and
  • For programs enrolled in the HCV RNA testing component, additional training on HCV RNA specimen collection, handling, processing and shipping.

For additional information on Staff Training, please see Quality Assurance.

Counseling Messages

All staff must be knowledgeable of HCV and be able to effectively deliver appropriate HCV counseling messages based on the rapid test result and the clients’ reported risk behaviors.  For programs providing HCV RNA testing on-site, P&Ps should designate staff responsible for conducting and delivering HCV RNA test results.  Additional guidance for staff conducting HCV RNA testing should include interpreting HCV RNA test results, providing appropriate counseling messages and referrals, disease reporting and other documentation requirements.    

Interpreting HCV Rapid Test Results - Referral for Diagnostic Testing (HCV RNA) and Medical Care

It is important that staff are competent in providing test results and can determine the appropriate counseling messages and referral information based on the test results.  Both non-reactive and reactive test results should be recorded on a laboratory results form and given to the client.  Based on the clients’ test results and behaviors, staff should provide the appropriate counseling message and referrals.  For additional information on referrals please see Linkage to Diagnostic Testing & Care.

Recordkeeping

Recordkeeping is a vital component of NYS LSL testing, showing that the HCV rapid antibody test was performed properly and all required steps were completed.  Details on Quality Assurance (QA) activities can be found under Quality Assurance.

Data Entry

Policies and Procedures must include guidance and instruction on submitting client-level testing data to the New York State Hepatitis C Virus Testing Program monthly.  Additional information on data reporting can be found in Ordering Supplies and Data Reporting.

Summary

A comprehensive policy and procedure manual is a valuable resource for NYS LSLs conducting HCV rapid antibody testing.  Although product package inserts can be used as test procedures in the P&P, these instructions should be supplemented with testing information that is unique to the agency's LSL operations and workflow.  P&P’s can also include examples of logs used to record daily temperatures, control testing and test results.  New testing procedures should be reviewed by the laboratory director before incorporating them into the procedure manual.  P&P’s should be updated as tests or other aspects of the program changes and reviewed annually.