New York State Hepatitis C Testing Program Requirements

What are the New York State Hepatitis C Virus Testing Program Laboratory-related Requirements?

In New York State (NYS), the Department of Health’s (DOH) Clinical Laboratory Evaluation Program (CLEP) is authorized under Section 579 of Article 5, Title V of the Public Health Law to provide oversight to facilities performing waived and/or provider-performed microscopy procedures. These facilities are considered Limited Service Laboratories (LSL) and must register through the NYS CLEP to obtain a federal Clinical Laboratory Improvement Amendments (CLIA) number and authorization to perform patient testing.

To participate in the NYS HCV Testing Program, all programs must register with NYS CLEP as a Limited Service Laboratory (LSL) to conduct the OraQuick® HCV Rapid Antibody Test.

For assistance with establishing and maintaining a NYS LSL, refer to NYS CLEP’s “Limited Service Laboratory Application Process Video Series” at

What is a Waived Test?

CLIA defines a "waived" test as a test that is easy to perform and has a little to no risk to the patient if performed incorrectly. The OraQuick® HCV Rapid Antibody Test is CLIA-waived for use with fingerstick and venipuncture whole blood specimens from individuals 15 years and older. Sites performing waived testing must follow federal, state and local requirements for testing, safety, and confidentiality of personal information.

What is a Limited Service Laboratory?

A facility that restricts laboratory testing to waived testing and/or provider-performed microscopy procedures (PPMP). These are point-of-care tests, conducted where the patient receives care. The following are examples of limited service laboratories: hospital extension clinics, nursing homes, home health care, school/student health services, dialysis facilities, ambulatory surgery centers, county health departments, correctional facilities, community clinics, homeless shelters, and ambulance/rescue squads.

How does a facility register as a Limited Service Laboratory in New York State?

All programs enrolling in the NYS HCV Testing Program must be registered with the NYS CLEP as a LSL and approved to offer HCV rapid antibody testing. Programs must register with NYS CLEP to obtain a federal CLIA number and receive authorization to perform patient testing via a LSL Registration Certificate.

For Programs Registered as a Limited Service Laboratory

Programs that have already registered as an LSL can use the “Search Registered Limited Service Laboratories” search tool on the NYS CLEP website to find their LSL Registration Certificate. To search for a program’s certificate, use the search tool on the following website:

• https://www.wadsworth.org/regulatory/clep/limited-service-labs
• NYS Limited Service Laboratory (LSL) Registration Certificate Requirements

For Programs Newly Registering as a Limited Service Laboratory

Interested programs must complete a registration application and submit all required paperwork to NYS CLEP by mail and with original signatures- along with a $200 application fee. All LSLs must designate a licensed health care practitioner who will function as site director and provide technical and clinical oversight of testing. Only individuals currently certified by NYS as laboratory directors, or individuals authorized by law to order and use laboratory tests in their practices, are eligible to be designated as directors of LSLs.

• The LSL registration application can be found on the following website at:
  • https://www.wadsworth.org/regulatory/clep/limited-service-lab-certs

  Not-for-profit, state or local government laboratories or programs engaged in limited public health testing not exceeding fifteen types of tests per registration may be eligible to apply for a multi-site network registration. The NYS HCV Testing Program recommends consulting with NYS CLEP when submitting an initial LSL registration for questions related to completing the application appropriately.

  CLEP Contact Information

  General Information

  • (518) 485-5378
  • Fax: (518) 485-5414
  • CLEPLTD@health.ny.gov

  Limited Service Laboratory Information

  • (518) 402-4253
  • CLEPLTD@health.ny.gov

  New York State Limited Service Laboratory Registration Certificate Requirements

  General Requirements for testing include:

  • All LSLs must have a laboratory director responsible for the testing performed;
  • Perform only waived tests listed on the LSL Registration Certificate;
  • Follow the current manufacturer’s instructions for the waived tests performed, without modification;
  • Pay the certificate renewal fee every two years; and,
  • Notify NYS CLEP of any changes in laboratory ownership, name, address, or laboratory director within 30 days, or if adding and/or deleting tests.

  What "Tests" or "Services" should be listed on the New York State Limited Service Laboratory Registration Certificate to Participate in the NYS Hepatitis C Virus Testing Program?

  HCV, Rapid

  If the enrolling program is conducting other waived tests and is registered with CLEP as a LSL, HCV, Rapid must be listed on the LSL Registration Certificate.

  If HCV, Rapid is not currently listed on the LSL Registration Certificate, then the program must add this test to their certificate. The form, Notification to Add and/or Delete Test Procedures (DOH-4236e), must be completed and the original submitted by mail to NYS CLEP. A new LSL Registration Certificate will be issued to the program. LSL Registration Certificates must be present in the facility and/or at all sites where testing is being conducted.

  Community Screening

  Programs conducting HCV rapid testing off-site in the field, on mobile vans or in other locations where staff are transporting test kits to and from the LSL Primary Site location, must have Community Screening listed on their LSL Registration Certificate.

  If Community Screening is not currently listed on the LSL Registration Certificate, and the program will be conducting testing in the field, then they must add this test to their certificate. The form, Notification to Add and/or Delete Test Procedures (DOH-4236e), must be completed and the original submitted by mail to NYS CLEP. A new LSL Registration Certificate will be issued to the program. LSL Registration Certificates must be present in the facility and/or at all sites where testing is being conducted.

  Additional Maintenance and Notification of Change in New York State Limited Service Laboratory Registration Status

  The LSL Registration Certificate must be updated within 30 days to reflect the below-referenced changes. Change forms and any accompanying documentation must be returned by mail only (with original signatures). The submission of duplicate (faxed or e-mailed) and/or incomplete paperwork will delay the processing and the issuance of amended registration certificates. Change forms are available on the NYS CLEP website.

  • Change in Laboratory Director;
  • Change in Laboratory Owner Information;
  • Change in Laboratory Location;
  • Add and/or Delete Test Procedures; and
  • Change in Laboratory Name.
  • Change in Laboratory Name.

  What are the Laboratory Director Requirements for New York State Limited Service Laboratories?

  LSL's must have a laboratory director who is responsible for all testing performed. NYS licensed medical doctors, doctors of osteopathy, dentists, nurse practitioners, certified nurse midwives or physician’s assistants can act as laboratory director at laboratories performing waived or PPMP testing. Ph.D.’s and individuals holding a Doctor of Science may act as director at laboratories conducting waived testing only. Reference: Public Health Law, Standards of Practice and Good Laboratory Practice Materials.

  What are the Responsibilities of a Laboratory Director?

  NYS Public Health Law Section 579-3(c)(vi) A-G defines the responsibilities of the laboratory director. The laboratory director’s role should be documented in the program policy and procedure manual. Laboratory directors may delegate some of their responsibilities to an experienced, trained, and competent staff person. A description of delegated responsibilities, including a defined pathway for how the laboratory director is informed of problem situations, particularly those where immediate action is required, should be documented in the program policies and procedure manual. NYS Public Health Law holds the laboratory director ultimately responsible for all testing performed. Reference: Public Health Law, Standards of Practice and Good Laboratory Practice Materials.

  The laboratory director is responsible for:

  • 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 test performed;
  • Making sure all tests are performed as written in the manufacturer’s package insert or device user’s guide;
  • Maintaining complete 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).

  What are some Additional Requirements for Limited Service Laboratories conducting the OraQuick ® HCV Rapid Antibody Test?

  Staff Competency

  Competency assessment is an essential procedure to make sure that staff are following the proper test procedure after initial training and should be performed every six months or at least annually. Additional details on staff competency can be found under Quality Assurance.

  Quality Assurance (QA) System

  All enrolled programs must have a quality assurance system that checks the whole testing process from start to finish. Additional details on Quality Assurance (QA) Systems can be found under Quality Assurance.

  Authorization for Testing

  Tests performed by NYS LSLs must be ordered by a physician or other health care provider, such as a nurse practitioner or physician assistant, who is legally authorized (by NYS professional practice law) to use the results of clinical laboratory tests in the practice of his or her profession. Additional details on provider authorization can be found under Provider Enrollment.

  Disease Reporting Requirements

  Unlike positive anti-HCV EIA test results, HCV rapid antibody reactive test results are not reportable to the Local Health Department (LHD). Additional details on reporting can be found under Ordering Supplies and Data Reporting.

  Patient Privacy and Confidentiality in New York State (NYS)

  The Health Insurance Portability and Accountability Act of 1996 (HIPAA) addresses the protection and privacy of personal health information. Testing sites are required to include in their policies and procedure manual steps on maintaining the privacy of health and personal information of their clients. Protecting client privacy includes patient identification, test results, and all records of testing. HCV rapid testing results—non-reactive and reactive—are considered HIPAA protected information. All program staff should receive HIPAA confidentiality training at least annually. For more information on HIPAA visit http://www.hhs.gov/ocr/hipaa.

  New York State and Federal Regulations for Occupational Health and Safety

  As indicated in the OraQuick® HCV Rapid Antibody Test Kit Package Insert, before performing the testing, all operators MUST read and become familiar with Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and other Bloodborne Pathogens in Health-Care Settings. Additional details on Occupational Safety and Health Administration (OSHA) Standards are available at Quality Assurance.