Rapid HIV Testing Workbook and Implementation Guidelines for Limited Testing Facilities in New York State

Table of Contents

Introduction

Any organization that performs a rapid HIV test in order to provide results to patients is considered  a laboratory under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). In NYS, all laboratories must register with the New York State Clinical Laboratory Evaluation Program (CLEP) and comply with public health law and regulations. For information on how to apply for a CLEP permit go to: http://www.wadsworth.org/labcert/limited/index.htm  Even though rapid tests are relatively simple to use, things can go wrong. To help find and prevent problems, CLEP requires the basic elements of a Quality Assurance (QA) program to be in place before offering testing. This workbook outlines the basic elements of a QA program. Each site needs to decide which rapid test product to use and how to fit the various QA elements of that product into its own workflow and system of operation. These guidelines are intended to assist providers who wish to implement rapid HIV testing under a limited service laboratory status, in developing policies, processes and procedures to ensure high quality HIV testing services. Sample tools are provided to demonstrate documentation and tracking requirements.

Establishing a Quality Assurance Program

Resources and staff are needed to establish and maintain a QA program, no matter how simple the test is. Someone must oversee the program and ensure the necessary staff and supplies are available. An authorizing medical provider is need to order tests and carry out the laboratory director responsibilities. Each organization must:

  • Identify a Laboratory Director.
  • Complete and submit an application to become a Limited Service Laboratory.
  • Assign a designee(s) for program oversight to ensure compliance with established policies and procedures based upon the New York State Public Health Law and other regulatory requirements.
  • Identify the person(s) responsible for conducting the rapid testing program.
  • Develop policies and procedures and make them available to all staff involved in rapid testing:
    • Rapid HIV testing will require modification to HIV testing protocols. Organizations will need to consider the logistics of how information about the test should be given, and identify when the informed consent will be obtained, prior to collecting a specimen for testing, and determine how the elements of prevention counseling will change using rapid tests.
    • Procedures should be established for setting up the work space, labeling testing devices, completing reporting forms and identifying each person's specimens tested to ensure specimens do not get mixed up during the testing process.
  • Obtain inventory of supplies (product information) needed to conduct HIV testing, up to and including disposal of medical waste.
  • Verify the testing process and develop an implementation plan for how rapid testing is integrated into existing services. This plan should address possible program concerns such as:
    • Client flow and demand for services.
    • Review of program operations and the appointment schedule, client flow and confirmatory test procedures.
    • The need for flexibility in appointments to accommodate the amount of time necessary to deal with preliminary positive results and the collection of confirmatory specimens.
    • The possibility of needing staff backup to assist at a clinic that may have an increase in demand for services.
    • The need to prepare clients prior to conducting HIV testing. Clients should be informed ahead of time of the available testing options (e.g., post a sign, have a client information sheet/pamphlet available, share information upon making the appointment, show a video in the waiting area).
  • Ensure staff is properly oriented, trained, perform procedures correctly and attend annual updates.
  • Create mechanisms for communication so that those who conduct testing and oversee programs are informed about QA issues.
  • Develop a method to detect and resolve problems that occur at any point in the testing process, especially those that may affect the accuracy of test results.
  • Create a remedial action plan and make it available to all staff who conducts testing.
  • Develop and implement mechanisms to ensure confirmatory testing when needed.
  • Ensure OSHA regulations are followed for employee, client and community safety.

Personnel Issues

Having qualified, trained staff to manage and perform rapid testing, along with the various QA activities, is one of the most important factors for ensuring accurate and reliable results. Key aspects include:

  • Qualifications
  • Training
  • Competency Assessment (i.e., ability to manage and/or perform rapid testing)

Qualifications

The current rapid tests are simple tests classified as waived, and therefore free of many requirements of the Clinical Laboratory Improvement Ace (CLIA). A waived test must be conducted in compliance with the manufacturers' product insert instructions. There are no specific federal or state educational requirements concerning who can perform a waived test. It is recommended that the individual have a high school education or its equivalent and that the following qualities be considered when selecting personnel to perform rapid testing:

  • Sincerity and Commitment - A dedication to perform HIV 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.

Training

Training is crucial to ensuring quality rapid testing. Staff should be fully trained on how to perform their assigned tasks and responsibilities. Job orientation and training should be documented for each staff member. Using checklists is one way to handle this documentation. The key components to include in training associated with HIV counseling and rapid testing are:

  • HIV counseling and testing skills
  • NYS Public Health Law - confidentiality, HIV reporting and partner notification
  • Laboratory regulations, Part 58-8
  • How to perform the test (including procedures performed before, during and after testing)
  • How testing is integrated into the overall counseling and testing program
  • QA program elements and documentation
  • OSHA guidelines (i.e., exposure control plan of universal precautions, bio-hazard safety)

Competency Assessment

Before an employee is permitted to perform a rapid test on their own, his/her ability to conduct the test should be demonstrated and documented. This assessment should also be carried out at periodic intervals after training, such as every six months or as determined by the testing site and it must be documented. This assessment can be carried out in many ways, but, regardless of the method, every task for which a staff member is responsible should be evaluated and performance documented. A supervisor should perform the assessment using a combination of methods to determine competency. Direct observation using a "check list" is one form of assessment. Observing staff conduct product external controls is another strategy to assess staff proficiency.

Conducting HIV Rapid Testing

Process Control

Rapid HIV tests allow for a very different approach to specimen collection and HIV testing. Designated staff can assume responsibility for both specimen collection and for the testing that was previously conducted in a licensed laboratory. The method of administering the test is dictated by the manufacturer's instructions. The activities and techniques that are carried out to ensure that the testing procedures are performed correctly, that the environment is suitable, and that test kits work as expected to produce accurate and reliable results, is called process control.

Before Testing

  • Check inventory and test kit lots, per established protocol.
    • Ensure sites are appropriately stocked with material needed to conduct testing. Procedures should be in place to ensure that an adequate supply of unexpired test kits, controls and testing medical supplies are available. Test kits and controls have a defined shelf life. Use the oldest first. Never use test or control kits beyond their expiration dates. It is helpful to use a log sheet to document when test and control kits are received, their lot numbers and expiration dates.
    • Once quality control kit vials are opened, they are stable for a certain number of days dictated by the manufacturer. Therefore, record the date that the control is opened and discard unused opened controls after the stated time period.
  • Check storage and room temperatures daily.
    • Procedures for storage of the supplies, setting up the testing area and conducting a test must be developed. Test kits and quality control kits must be stored in an environment within the temperature control ranges specified by the manufacturer. Test kits can be stored refrigerated or non refrigerated as long as they remain in the environmental range dictated by the manufacturer. If test kits are refrigerated, devices should be brought to room temperature before using. Control kits must be refrigerated at 2° to 8° C (35° to 46° F). Control kits are also brought to room temperature before use. Please see Manufacturers' product inserts for product specific details.
    • To ensure these temperature ranges are maintained, monitor and document temperatures of the storage areas each day testing is performed. If the temperature falls outside of the specified range, take action as needed to adjust the temperature. To monitor the temperatures, place thermometers in the storage areas (e.g., in the refrigerator and on the shelf in the room where kits are stored). Check and record temperatures on a log sheet each day testing is performed. An example of a temperature log is provided in this manual.
    • The environment in the area where the test will be performed must be within a certain temperature range. Temperatures of the testing site must be recorded prior to conducting a test. The kind of heating system utilized and whether there is an air-conditioning system present that is operational and used during clinic hours are important considerations. If the test must be performed at a temperature below the range dictated by the manufacturer, an external control must be run to ensure the test operates correctly. Rapid tests can be used in mobile settings. If testing is carried out in the field, monitor the temperature of the test and control kits in their portable storage containers and check the temperature where testing will be performed and processed. If there are doubts about the testing area temperature or whether test kits have stayed within the appropriate temperature range, run a positive and negative external control as described in the quality control section.
  • Perform external quality control according to manufacturer's instructions prior to conducting testing.
  • Establish test area readiness.
    • Before performing the test, ensure that there is an adequate level of lighting. Bright fluorescent lighting may require the lamps to be covered with light diffusers. In addition, blinds/curtains should be adjusted appropriately.
    • The work space to perform the test must include availability of a flat surface. Hand washing facilities must be in close proximity or hand sanitizer must be used if there is no sink (soap/water) available.

During Testing

  • Provide HIV information, subject information sheet and conduct the informed consent according to the NYS Public Health Law.
  • Follow biohazard safety precautions according to OSHA standards.
  • Collect specimen as per manufacturer's requirement (blood/oral fluid).
  • Perform the test as per manufacturer's instructions.
  • Read and record the test result on a Lab Result Slip.

After Testing

  • Report the result to client; ensure client understands meaning of result.
  • Document results in client chart and on master log.
  • Clean up testing area and dispose of biohazardous waste.
  • Collect, process and transport confirmatory test specimens if rapid test reactive.
  • Manage confirmatory testing and results, when indicated.
  • Follow up with client and provide appropriate referrals as discussed in the counseling session.

Quality Control

There are two types of quality control (QC) for the rapid tests. Internal controls are built into each testing device to verify that the specimen is adequate and the solution flowed through the devices as intended. External controls are known reactive and non-reactive reagents (control specimens). They are available from the manufacturer to sites purchasing the rapid HIV product and are used to evaluate the accuracy of the test in detecting HIV antibodies and to verify that the person conducting the test is performing it correctly.

Internal Controls

Devices include a built-in (internal) control. When a complete single line develops in the "C" location on the device, the client's specimen has been correctly loaded and traveled through the test strip, indicating a valid test. Additional information is provided in the test kit package insert. Internal control information varies according to the product. If the internal control does not produce the expected result, the test is not valid, can not be reported to the client, and must be repeated. Refer to product insert, for repeat testing instructions.  More that two invalid results requires action, usually evaluation of external controls, before testing can continue. The organization must develop a remedial action plan for staff conducting HIV rapid testing to follow in the event of an invalid test result.

External Controls

To verify that the test device is accurately detecting HIV-1 or HIV-2 antibodies, external positive and negative controls must be tested from time to time. Control kits are ordered separately from the test kit. Control kits contain 2 or 3 vials of an HIV antibody-negative (non-reactive) and positive (HIV 1 and/or 2 reactive) human plasma reagent. How often controls are run to verify the accuracy of the test are described in product inserts. These guidelines depend upon the number of tests carried out by the site, how often new test kit shipments or lot numbers are received by a site, changes in how the tests are stored and in testing area temperatures and how often staff who conduct the testing change.

Manufacturers have established guidelines for the minimum number of times to run controls. This is described in the product’s test kit instructions, which specifies running controls for each product. Most controls are run under the following circumstances:

  • By each new employee prior to performing testing on patients;
  • 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);
  • Whenever a new shipment of test kits is received (even if it is the same kit lot number in current use);
  • If the temperature of the test storage area falls outside of dictated range;
  • If the temperature of the testing area falls outside of dictated range; and
  • At periodic intervals as dictated by the user facility.

In addition to the specific circumstances listed, testing sites should determine the optimal frequency for running controls based upon their testing 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 a confirmatory test was ordered).

Sites testing large numbers of persons 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. Instructions for other waived tests recommend running external controls each time a new box of 25 tests is opened. It is recommended for facilities that test 25 or more clients a day to run controls every day. Low volume sites, such as those testing fewer than 25 clients per month, should run external controls every two to four weeks at a minimum. Controls should be run more often if new lots of shipments are opened or if storage or testing temperatures fluctuate. Control results must be documented and logs maintained to prove QA practices are followed.

Each site should have a method to detect and resolve problems that occur at any point in the testing process, especially those that may affect the accuracy of test results. Significant problems should be immediately reported to the appropriate supervisory personnel/laboratory director.

Trouble-shooting

Written procedures should be available to all testing personnel for the following:

  • When to discontinue testing (e.g., when the external control results are unacceptable as described in the package insert).
  • How to take corrective action, or an action taken in response to a problem (e.g., contacting the manufacturer when the external control results are unacceptable and following the advice provided).
  • How to document problems and action taken (e.g., a logbook where problems and corrective actions taken can be recorded).
  • How to verify that the corrective actions taken addressed the problem.

Rapid Tests Results and Confirmatory Testing

Test sites must follow the manufacturer's instructions for performing the test and reading the test results. Results can only be one of the following:

  • Nonreactive (negative)
  • Reactive (preliminary positive)
  • Invalid (the test result can not be interpreted)

Confirmatory Testing

The standard HIV testing algorithm in NYS consists of a screening test followed by a “supplemental” or “confirmatory” test whenever a rapid test result is reactive (preliminary positive).  A confirmatory test by a licensed laboratory must be performed to confirm that the person being tested is infected with HIV. Therefore, each site must have established procedures for confirmatory testing when there is a rapid reactive result. Specimens for additional testing should be collected immediately following the rapid test preliminary positive.  The site must have procedures describing how to collect, label, process, store and document specimen transfer; transport the confirmatory test specimens to the lab where the specimen will be tested; and obtain the confirmatory results to give to the client. A sample log on how to document and track specimens transfer to a lab is included in the appendices.

The standard testing algorithm protocol should be followed for confirmatory testing, with the following exceptions:

  • All reactive (preliminary positive) results must be followed up with either a Western blot or immunofluorescent assay (IFA) or other supplemental tests for confirmation.
  • Confirmatory testing can be done on blood (plasma, serum or dried blood spots) or oral fluid specimens. Urine testing should not be performed due to its lower sensitivity (i.e., ability to detect positive results). supplemental testing using blood to conform a diagnosis is preferred.
  • With blood specimens, enzyme immunoassay (EIA) screening tests prior to the Western blot or IFA confirmatory test are optimal. If an EIA is performed, even if it is non-reactive, the specimen must proceed to Western blot or IFA testing (reactive EIA specimens will automatically be tested by Western blot or IFA). For oral fluid testing, both EIA and Western blot testing should be performed to confirm results.

Note: Test sites should be familiar with multiple test algorithms that may be carried out by reference labs to confirm HIV infection.

Most confirmatory test results will be positive; however, some may be negative or indeterminate. If the confirmatory test result is negative, in order to determine whether or not the preliminary positive result was a false positive, specimen mix-up needs to be ruled out. If the Western blot or IFA test is negative, it is recommended that:

  • For blood specimens, additional supplemental tests or the confirmatory test should be repeated with a new specimen to rule out specimen mix-up. If available, an RNA test should be requested of the lab.
  • For oral fluid specimens, a repeat confirmatory test with a blood specimen should be done, since the oral fluid test is less sensitive than the blood test.
  • Occasionally, confirmatory test results are indeterminate. If the Western blot is indeterminate or an IFA is indeterminate, it is recommended that:
    • For blood specimens, another blood specimen should be collected and a request for WB and RNA testing ordered.
    • For oral fluid specimens, the Western blot or IFA test should be repeated using a blood specimen. Providers may also order an RNA test.

Note:  RNA testing is not available through all laboratories.  Please consult with your State/City Public health laboratory.

Confirmatory testing should follow established procedures describing how to match the client's confirmatory test results with their rapid test result; assist in identifying potential discrepancies; reporting of the test result to the person tested; and instructions on how to obtain any additional specimens needed. All confirmed HIV positive test results are reported to the NYSDOH. Information on HIV reporting requirements can be found at: http://www.health.ny.gov/diseases/aids/regulations/reporting_and_notification/question_answer.htm

Discrepancies

Procedures should describe how to handle result discrepancies when the rapid test result was reactive and the confirmatory test negative or indeterminate. If the laboratory providing confirmatory testing performed an EIA test only and reported a non-reactive or negative result, the testing site should contact the confirmatory testing laboratory and request a Western blot test or IFA test. If the original specimen is not available, a new specimen will need to be collected from the person in question to be used for confirmatory testing. Additional steps should be outlined to ensure specimen mix-up has not occurred and how to resolve a potential specimen mix-up and retest, as needed.

External Assessment

External assessment, or an evaluation of the testing process by a source outside the testing site, can evaluate how testing is being performed and whether it is being performed reliably. It can also help to identify existing or potential problems. Moreover, information gathered can provide an educational tool to improve performance. Some form of external assessment is highly recommended. It is not required by federal (CLIA) or State (CLEP) regulations since the test is waived and the test kit manufacturer does not specifically require it.
Every reactive rapid test is externally assessed by a second, confirmatory test. However, if there is a low prevalence of HIV infection in the population being tested, these assessments may be infrequent and will not provide an external check for the majority of the results (i.e., those that are non-reactive).
Other ways to assess performance may be needed. Some external assessment mechanisms include:

  • Comparing the rapid test reactive results with the confirmatory test results.
  • Arranging for someone outside the organization to observe testing.
  • Participating in a proficiency testing or external evaluation program.

Documentation

*Sample forms are available as attachments

Conducting HIV rapid testing requires the development of new forms, tracking logs and documentation systems to fulfill the requirements of a laboratory status. Policies and procedures describing the rapid test records are required, in regard to how and when they are reviewed, stored and destroyed.

Having periodic supervisory review of these records is recommended and ensures staff is following established protocols. Laboratory records should be retained for a period of two (2) years to demonstrate compliance. These records should include permit and CLIA documentation, staff training documentation, HIV test result logs, and specimen transfer logs for confirmatory tests, temperature logs, and external control result logs.

Temperature logs should include a daily record of the refrigerator temperature in which controls are stored, the temperature where test kits are stored and the temperature of the testing area. Thermometers should be placed in each location. Laboratory grade thermometers can be purchased from medical or laboratory supply houses and are recommended. Their accuracy should be checked periodically (e.g., every six months) by comparison with another thermometer. Batteries should be changed at regular intervals.

External control records should include the date and time of control testing, lot result logs number and expiration 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 kept in the order in which they were completed so they can be easily compared with the test records. This will help find answers if there are questions about testing performed within a specific time frame.

Rapid test results should be documented on a Lab Result form. In addition, test results should be recorded and logged each day of testing. Logs should include the date and time of testing, an identifier for the person being tested, a test kit lot number and expiration date, test result, action taken if the result was invalid, identification of the person who performed the test, whether confirmatory testing was completed, including the type of specimen sent for confirmation (e.g., oral fluid, blood) and the confirmatory test results when they are available. If more than one person is conducting testing, there should be a mechanism to chronologically link the test record log sheets to detect problems, such as invalid results occurring repeatedly with the same kit lot number.

Additional Resources

The Centers for Disease Control and Prevention (CDC) offers several documents that are very helpful in developing a HIV rapid testing program such as “General and Laboratory Consideration: Rapid HIV tests Currently Used in the United States”  as well as updates and other information regarding products approved by the FDA.