New York State Hepatitis C Rapid Testing Program - Quality Assurance

NYS Hepatitis C Rapid Testing Program Implementation Guide Home Page

The New York State Hepatitis C Virus Rapid Testing Program (NYS HCV RTP) works with all enrolled and enrolling programs to assist with implementing and maintaining a quality Limited Service Laboratory (LSL) and testing program.

What is a Quality Assurance (QA) System?

Programs enrolling in the NYS HCV RTP are required to conduct and document QA activities.  A QA system checks the whole testing process from start to finish to ensure that staff are providing quality LSL services.  Required elements as listed in the “New York State Guidance for Standard Practices in Laboratory Medicine for Limited Service Laboratories” include the following:

  • The selection of a test;
  • Proper training of all staff;
  • Appropriate specimen collection procedures;
  • Monitoring of environmental conditions;
  • Using quality control materials as required and obtaining expected results;
  • Performing the test per the package insert;
  • Accurate recording and delivery of test results; and,
  • Recording and investigation of any unexpected results.

What testing records must be maintained by Limited Service Laboratories in New York State?

As stated in the “New York State Guidance for Standard Practices in Laboratory Medicine for Limited Service Laboratories” , recordkeeping is a vital component of laboratory testing.  This process shows that the HCV rapid antibody test was performed properly and all required steps were completed.  Paper logs or electronic systems can be used for maintaining and tracking LSL information.  Testing records should be maintained in chronological order to facilitate retrieval of information.  The Laboratory Director or designee is responsible for testing oversight and periodic records review.  The following records should be maintained by programs conducting HCV rapid antibody testing:

  • Evidence of Laboratory Director oversight of testing program;
  • Temperature logs for storage and testing spaces;
  • Quality control records including the name of the test, site performed, date, time, lot numbers, dates, expected and observed results, and staff who performed each test;
  • Patient test result logs including the kit lot numbers, expiration dates, date patient test performed, patient result and staff who performed the test;
  • Initial device training and annual competency records for all testing staff; and,
  • Maintenance records showing device maintenance or service.

The NYS HCV RTP recommends that enrolled programs keep QA documentation in a central location.  For programs keeping paper records, it is recommended that all QA logs be kept in a LSL manual or binder.  Sites with a LSL multi-site network registration must have consistent operations and documentation systems across all locations. 

Evidence of Laboratory Director Oversight of the Testing Program

The NYS HCV RTP recommends regular, designated supervisory review (i.e., monthly) of all LSL QA documentation.  Additionally, there should be evidence of Laboratory Director oversight of all testing activities, including an annual review of policies and procedures and all QA documentation.

Programs enrolled in the NYS HCV RTP must maintain records of temperatures for test and control kit storage and testing spaces for the OraQuick HCV Rapid Antibody Test per manufacturer guidelines.  These may be either hard copy or electronic.  Records should be easily accessible and have evidence of routine review.  It is recommended that supervisors review temperature logs monthly, and Laboratory Directors, at least annually.  If the program is conducting multiple rapid tests, a combined temperature log can be used.  However, recommended temperature ranges for the different test kits should be displayed on the log or available for staff to review (e.g. reference ranges posted in the laboratory), as temperature ranges are determined by the manufacturer and vary from test to test.  Actions to take for out of range temperatures are test-specific and determined by the manufacturer.

Required OraQuick® HCV Rapid Antibody Test Temperature Records

  • Storage Area temperatures for HCV Rapid Test Kits (2°-30°C, 36°-86°F) recorded daily;
  • Storage Area temperatures for HCV Controls (2°-8°C, 36°-46°F) recorded daily; and
  • HCV Rapid Testing Areas (15°-37°C, 59°-99°F) temperatures measured and recorded on all days and for all locations where testing occurs.

*Sample templates will be provided in the appropriate section listed below.

Storage of HCV Test Kits and Controls

HCV rapid antibody test kits (OraQuick HCV Test Kit Package Insert) and external controls (OraQuick HCV Kit Control Package Insert) must be stored at the appropriate temperatures to ensure product integrity.  Kits and controls must also be stored in a secure area to prevent tampering.  Thermometers must be kept in all storage areas. NYS HCV RTP and NYS Clinical Laboratory Evaluation Program (CLEP) recommend the use of thermometers with data logging capabilities, as these provide a record of daily temperature readings and ensure that the maximum/minimum temperature ranges have been maintained during times when staff are not present at the program.  Temperature ranges are precise, and any fluctuation outside the manufacturer-determined temperature range should be communicated to the program’s Laboratory Director or designated staff person.

Corrective action for temperatures that go above and below the range will include adjustment to the environmental condition (i.e., heat or air conditioner).  If storage temperatures fall out of range, an external control should be performed on the supply to ensure product quality.  Corrective action should be documented on the temperature log and reviewed by a supervisor and/or Laboratory Director, if applicable.

HCV Test Kit Storage

Temperatures should be taken and recorded daily (including weekends and holidays via data logging or laboratory grade thermometers).  Store unused OraQuick® HCV Rapid Antibody Tests unopened at 2°-30°C (36°-86°F).  Do not open the divided pouch until staff is ready to perform a test.  If stored in the refrigerator, ensure that the divided pouch is brought to operating temperature (15°-37°C, 59°-99°F) before opening.

HCV Control Storage

Temperatures should be taken and recorded daily (including weekends and holidays via data logging or laboratory grade thermometers).  Store the OraQuick® HCV Rapid Antibody Test Kit Controls at 2°-8°C (36°-46°F).  Open the Kit Control vials only when performing controls.  Unlike test kits that need to be brought to room temperature before use, controls should be taken from storage, used, recapped and stored immediately in their original box at 2°-8°C (36°­-46°F).  

Do not use Kit Controls beyond the expiration date printed on the outer box.  Once opened, Kit Controls should be discarded after eight weeks.  Controls should be labeled with the date opened and discard date (8 weeks from date opened or expiration date printed on the box).  Do not use controls if the reagent appears cloudy or discolored.

HCV Testing Areas

Temperatures must be taken on all days and for all locations where testing is conducted.  This includes individual clinic rooms, mobile vans, and outreach events.

Tests should be conducted in an area/room which is environmentally stable, well-lit, has a flat stable surface (counter top/table) and offers privacy to the client.  A thermometer must also be kept in the testing area.  Each time a test or a control is conducted, the room temperature shall be recorded.  Testing area temperatures must fall in the range of 15°-37°C (59°-99°F).  A designated supervisor must conduct periodic direct observation of testing activities and ensure set up for testing and temperature readings are performed correctly.
Testing room temperature recordkeeping can be streamlined by documenting testing room temperatures on the patient result log (see sample patient result log provided below).

Quality Control

As described in the Control Package Insert, there are two different quality control measures for the OraQuick® HCV Rapid Antibody Test, internal controls and external controls. (OraQuick HCV Kit Control Package Insert)

Internal Quality Control

The OraQuick® HCV Rapid Antibody Test has a built-in procedural control that demonstrates assay validity.  A reddish-purple line in the Control Zone (C Zone) of the Result Window indicates that a specimen was added and that the fluid migrated appropriately through the Device.  The Control line will appear on all valid tests, whether the sample is reactive or non-reactive for anti-HCV.

External Quality Control

The OraQuick® HCV Rapid Antibody Test Kit Controls are human plasma based reagents.  The Kit Controls are specifically formulated and manufactured to ensure proper performance of the test.  The HCV Positive Control will produce a reactive reddish-purple line at the Test (T) Zone.  The HCV Negative Control will generate a non-reactive test result (no reddish-purple line at the Test (T) Zone).  Use of kit control reagents manufactured by any other source will not meet the requirements for an adequate quality assurance program for the OraQuick® HCV Rapid Antibody Test.

External controls must be run at specific times to ensure that the test devices on hand are accurately detecting the HCV antibodies.  Controls are ordered separately from test kits and include both positive and negative control vials.  Kit controls must be run per the manufacturer’s protocol and facilities must run both positive and negative controls.  

Per manufacturer’s package insert, external controls should be run under the following circumstances (OraQuick HCV Kit Control Package Insert) :

  • Each new operator prior to performing testing on patient specimens;
  • When opening a new test kit lot (a test kit lot is defined as the boxes of test devices that contain either 25 or 100 tests that have the same lot number labeled on the outside of the boxes);
  • When a new shipment of test kits is received;
  • If the temperature of the test kit storage areas falls outside of 2°-30°C (36°-86°F);
  • If the temperature of the testing areas falls outside of 15°-37°C (59°-99°F); and
  • At periodic intervals as dictated by the user facility (i.e., Laboratory Director).

Additional Manufacturer Guidance on the Frequency of Running External Controls Based on Test Volume

(OraQuick HCV Implementation Guide, see page #64)

In addition to the specific circumstances listed in the manufacturer’s instructions, testing sites should determine the optimal frequency for running controls on the basis of their test volume.  When external controls provide incorrect results, none of the tests that were run since the last time control results were correct can be considered valid.  This means that everyone who was tested since the last time controls ran correctly will need to be called back and retested (unless supplemental testing was ordered).  Sites testing large numbers of persons, and especially those that offer anonymous testing, should plan to run controls more often than facilities that conduct fewer tests.  Each site needs to decide how often to run controls based on its own situation and testing practices.  The CDC’s original guidelines recommend facilities that test 25 or more subjects a day should run controls every day.  Low volume sites, such as those testing fewer than 25 subjects per month, should run external controls every two to four weeks at a minimum.

If a control kit fails during testing of the control, staff should repeat test using a new test device, developer solution vial and control specimen.  If the control kit does not perform a second time, discontinue testing and contact the Laboratory Director and OraSure Technologies, Inc. Document failed control results and notify supervisory staff as directed in program policies and procedures.

All programs enrolled in the NYS HCV RTP must maintain proper external control records as required for registered LSLs.  Control records must include the date and time of control testing, lot number and expiration date of the test kit, lot number and expiration date of the controls, control results and corrective action taken if control results are unacceptable.  Control records should be logged in the order in which they were completed so they can be easily compared with the test records.   A designated supervisor should review quality control logs at least monthly to ensure that controls were run and recorded appropriately.

Training and Competency Records for all Testing Staff

Initial Device Training

NYS HCV RTP 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, Inc. will be provided as part of the enrollment process. 

Device training from qualified internal staff is allowable with approval from the NYS HCV RTP.  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). For more details on staff training, please see Staff Training.

Whether initial device training occurs from an internal or external source, there should be documentation of this training for all testers.  To ensure ease of review, NYS HCV RTP recommends that evidence of initial device training be maintained in a centralized LSL manual or binder for recordkeeping of all HCV testing documentation.

Annual Staff Competency Assessment

As stated in the “New York State Guidance for Standard Practices in Laboratory Medicine for Limited Service Laboratories”, competency assessment of testing staff is an essential component of a quality testing program.  The Laboratory Director or a delegated supervisor must ensure all testing staff can follow proper testing procedures.  Initial assessments should be completed on new testing staff prior to testing and at least annually for experienced staff.  These assessments should occur more frequently for staff requiring additional oversight.  Competency assessments should include observation of skills and testing of knowledge about how to handle discrepancies.  Conducting these assessments can help agencies:

  • Identify key areas for training and the need for improvement in various areas of the testing process;
  • Review testing staff performance; and,
  • Provide evidence to consumers, management, and overseeing authorities that testing staff are trained.

Ways to perform competency assessment include:

  • Person overseeing testing should watch testing staff collect, handle and process specimen to verify that the proper test procedure is being followed;
  • Having staff person re-test previously tested samples to check that the same result is generated;
  • Have staff person provide pre-test and post-test counseling message to ensure that current, appropriate messaging is being used;
  • Review program documents (temperature logs, patient logs, control logs, etc.) for accuracy and completeness;
  • Evaluate problem-solving skills (i.e., test does not produce desired result, temperature out of range, client wants to leave before results available, etc.); and,
  • Participate in additional training opportunities as needed and available.

Staff competency assessments should be documented and included in either the staff person’s personnel folder or LSL manual or binder.  The Laboratory Director should review competency assessments at least annually.

Additional Quality Assurance Activities

Inventory Management

Program staff must ensure that each testing site is appropriately stocked with the materials needed to conduct testing.  An adequate supply of unexpired test kits, external controls and testing medical supplies must be available and monitored by the program manager.  Since test kits and controls have a defined shelf life, the oldest should be used first. Test and/or control kits must not be used beyond their expiration dates. It is recommended that kits be rotated when a new shipment arrives to ensure that the oldest kits are used first.  It is also recommended that staff keep a record in the Quality Assurance (QA) log book of when a new shipment of kits and controls arrive and when they expire.  Efforts should be made to ensure that tests removed from the primary laboratory site for community screening events are returned to the primary laboratory site at the end of the day.  Protocols should be in place to maintain the integrity of testing products that cannot be returned to the primary laboratory site following off-site testing events.

NYS Hepatitis C Virus C Rapid Testing Program Site Visit and Desk Audit Procedures

The NYS HCV RTP will conduct periodic, routine on-site and desk audit program reviews.  These are informal reviews of LSL practices and program policies and procedures specific to conducting HCV rapid antibody testing for the NYS HCV RTP.  The CLEP program is responsible for regulatory oversight of the LSL.  The intent of these reviews is to provide technical assistance and ensure a quality HCV RTP that identifies and links to care those individuals at highest risk for hepatitis C.  We work collaboratively with enrolled programs to ensure appropriate storage of supplies, documentation of testing practices and referrals, and provision of effective counseling messages to clients. 

  • Site Visit Review Tool. Available Upon Request from NYS HCV RTP Staff.  To request this information, send an email to hepatabc@health.ny.gov.     
  • Desk Audit Review Tool. Available Upon Request from NYS HCV RTP Staff.  To request this information, send an email to hepatabc@health.ny.gov.     

Additional Resources