Quality Assurance Guidelines on HIV Voluntary Counselling and Testing Services in Community Settings

Quality Assurance Guidelines on HIV Voluntary Counselling and Testing Services in Community Settings
(Adopted from Community Forum on AIDS of the Hong Kong Advisory Council on AIDS, October 2009)
CME : 1 point / CNE : 1 point

Preamble

In recent years, there is an increasing trend of HIV tests being performed by peer colleagues in community settings. Some members of the target communities prefer to be tested in venues which they frequently visit. HIV rapid tests have become increasingly popular as clients prefer to know their HIV status at the point of testing. In order to benchmark the quality of these voluntary counseling and testing (VCT) services, Community Forum on AIDS (CFA) undertook to develop a set of guidelines by taking reference from the latest available scientific literature and customizing them for the local situation. Community organizations or non-governmental organizations performing conventional HIV tests in a clinical setting can also refer to these guidelines as well as clinical VCT guidelines of service providers in the public sector.

Basic Principles and Requirements for the provision of VCT Service

Client should exercise self-determination throughout the process of VCT.
Client has the right to confidentiality in terms of protection against disclosure of identity and test result.
Client has the right to be protected against all forms of discrimination.
Informed consent should be obtained from the client before VCT is conducted.
Client should receive accurate and comprehensive information regarding VCT and related issues, be given ample opportunity to ask questions, and have their concerns adequately addressed.
The service provider organization should set its own policy on age of consent based on their capacity and safeguards. In case of doubt, client could be referred to Department of Health (DH) for VCT.
VCT should be conducted in a suitable testing environment (e.g. a private room with good lighting and hygiene).
The service provider should keep updated with the latest developments to provide a quality VCT service.

Organization of VCT Service

Organizations providing VCT should:

Identify the person responsible for managing the VCT service.
Draw up its own protocol for VCT, preferably with input from its board / medical advisers.
Provide written testing instructions and site-specific procedures.
Train and assess the competency of personnel to ensure that they are able to perform the assigned tasks in accordance with instructions.
Secure a suitable venue for providing VCT.
Verify the testing process

Provide adequate pretest information to every test subject;
Check performance of new test kits and shipments, frequency of routine quality control testing and actions to take if control does not work;
Collect specimens, perform the test, interpret and inform client of test results, resolve problems before reporting results.

Establish referral mechanisms for confirmatory tests.
Maintain sufficient supplies of unexpired test and control kits and adhere to manufacturer's temperature ranges for storage and testing.
Ensure compliance with bio-hazardous waste handling and infection control guidelines.
Document records and timelines for review; retain and destroy when outdated .

Personnel

Personnel performing VCT should:

receive appropriate training and supervision;
be able to demonstrate competency in performing VCT; and
keep updated by attending VCT training and refresher courses.

Training may be provided by DH on a regular basis and its content agreed in advance after consultation with the service provider organization. Training may also be conducted within the service provider organization by experienced practitioners / supervisors for their colleagues.

A. Training Content

This should cover, but is not limited to:

√ How to integrate testing into the overall HIV prevention program
√ How to provide pre-test counselling
√ How to perform the test
√ Use and importance of blood and body fluid precautions and biohazard safety
√ How to provide post-test counselling
√ How to handle sensitive and emergency issues e.g. legal liability and age of consent, psychological reaction etc.

B. Training on How to Perform the Test

√ Read instructions for performing the test
√ Observe someone performing the test or video of someone performing the test
√ Practise performing the test with positive and negative control results
√ Practise performing the test
√ Review the procedures and forms on how to document testing

C. Competency Assessment

a. Assess performance of tasks done before testing

√ Check and record temperatures of the testing and storage areas
√ Set up testing area, label and test device and prepare control and test result log sheets
√ Run the external control and record results

b. Assess performance of tasks during testing

√ Observe whether personnel performs specimen collection and handling according to manufacturer's instructions
√ Observe how the test is performed on a client or on a volunteer
√ Assess the practice of universal or standard precautions
√ Review results obtained from testing a panel of referenced specimens that show a range of results, such as specimens that include non-reactive, weakly reactive and reactive results
√ Appraise the individual's ability to interpret results

c. Assess performance of tasks after testing

√ Review test records and quality control papers for documentation
√ If confirmatory test specimens are collected on site, observe the collection and handling of venous blood for referral
√ Verify that confidentiality is maintained

Process Control

Process control refers to activities and techniques that are carried out to ensure that the testing procedures are performed accurately in a suitable environment. Furthermore, the test kits should work as expected to produce accurate and reliable results.

A. Before Testing

√ Check storage and room temperatures daily
√ Check inventory and test kit lots, as needed
√ Receive request for testing
√ Provide HIV/AIDS test information to client
√ Set up test area, label test device
√ Perform external quality control according to the manufacturer's and the site's instructions

B. During Testing

√ Follow biohazard safety precautions
√ Take a blood droplet by finger prick
√ Perform the test
√ Interpret test results

C. After Testing

√ Document results
√ Report results to client
√ Collect, process and transport confirmatory test specimens or refer client for follow-up
√ Clean up and dispose of bio-hazardous waste
√ Manage confirmatory test results
√ Take appropriate steps to deal with problematic cases
√ Participate in periodic external quality assessment

Counselling

Counselling is an integral and important part of VCT. It offers a window of opportunity to share important HIV prevention information and provide clients with practical advice to reduce HIV risks.

A. Pre-Test Counselling

a. Welcome client to the service (ensure privacy of the setting).
b. Check client's particulars and previous attendance.
c. Explain about the test procedures and reassure about confidentiality.
d. Discuss potential implications of a positive and negative test result.
e. Inform client how to interpret and read results.
f. Provide health education advice on STI/HIV when necessary.
g. Explore client's risk behaviour and conduct HIV risk assessment when necessary.
h. Allow clients adequate time to ask questions and provide them with tailor-made information to address their concerns.
i. Obtain client's consent.

Throughout the counseling, be aware of client's mental and emotional status. If there are concerns, refer to a more experienced colleague or DH.

B. Post-Test Counselling

Give adequate time for counselling clients.

- Negative rapid test results

a. Explain that client is not infected unless blood was taken within the window period (second screening is required after the window period).
b. Provide counselling and negotiate plan for risk reduction.
c. Answer questions raised by client.
d. Remind client to call for advice if necessary.
e. Emphasize the need for regular HIV tests if client continues risk-taking behaviour.

- Positive rapid test results

a. Explain that this is a preliminary positive test result; further confirmatory test by Western Blot method is required.
b. Assess client's emotional state and level of acceptance.
c. Provide referral to DH AIDS Counselling and Testing Service (ACTS) (Tel: 2780 2211) and other resource materials for emotional support.
d. Discuss about HIV treatment / management if necessary.
e. Explain that HIV is now a chronic disease which can be managed by effective antiretroviral treatment.
f. Stress the importance of confirmatory test and follow-up for medical treatment if found positive.
g. Recommend client to consider partner referral once he/she accepts own newly diagnosed status.
h. Discuss ways of preventing HIV transmission to others.

- Invalid rapid test results (neither positive nor negative)

a. Explain the implication of the situation to client.
b. Arrange conventional blood test.
c. Refer to DH ACTS (Tel: 2780 2211).

C. Crisis Counselling

After being diagnosed HIV positive, the client may go through a crisis situation with emotional disturbance. The person may feel intensely threatened, shocked and helpless, as if losing control of his/her life. The goal is to help the client define problems quickly and restore a sense of control.

a. Encourage the expression of his/her feelings.
b. Be empathetic, show understanding and concern.
c. Explore with client the precipitating factors of the crisis, and facilitate client's understanding of the situation.
d. Review client's strengths to cope with the current crisis.
e. Summarize client's current situation.
f. Explore immediate concerns.
g. Select the most important issue to work on initially.
h. Provide helplines or other sources of support.

Infection Control

Standard precautions should be adopted by testing personnel and service providers at all times during VCT. These include good hand hygiene practices and use of protective barriers during patient care and blood taking. All blood and body fluids with potential/unknown risk of transmission should be treated as if infectious for blood borne diseases.

The Centre for Health Protection's Scientific Committee on AIDS and Sexually Transmitted Infections issued the following recommendations on HIV transmission in healthcare settings:

(a) Hands must be washed before and after procedural contact with client. Immediate hand washing is required if in touch with blood, body fluids and after glove removal. Soap and water are used for routine washing. Alcohol-based handrub can be used in place for maintaining hand hygiene. Remember gloves cannot substitute the practice of good hand hygiene.

(b) Gloves must be worn when there is direct contact or possibility of contact with blood, body fluids, mucous membranes and wounds of clients. Gloves should be changed between care of different clients. Gloves must be changed if they are torn, visibly contaminated with blood and in case of a needle-stick injury. Other personal protective equipment such as surgical mask should be worn when staff or clients have fever or respiratory symptoms.

(c) Client samples should be taken correctly by following strictly the instructions provided by manufacturers. Measures should be taken to prevent injuries by needles, lancets and other sharp instruments. Used sharp should not be recapped and should be placed in a puncture resistant box, which shall preferably be up to 3/4 full and must not be overfilled. These sharp boxes, after proper sealing, should be disposed as other medical wastes in accordance with procedures laid down by the Environmental Protection Department.

(d) Disposable equipment and accessories should be discarded as appropriate. Reusable items should be properly cleaned and decontaminated as necessary after use. Chemical disinfectants such as 0.1% sodium hypochlorite (add one part of household bleach into 49 parts of water) and 70% alcohol can be used for disinfection of contaminated articles, after removal of the soils.

(e) Environment contaminated with blood should be cleaned and disinfected immediately. Gloves should be worn before contact with blood or body fluid. For blood, cleanse the visible matter with disposable absorbent material soaked with 1% (add one part of household bleach into 4 parts of water) hypochlorite solution. After leaving for 10 minutes, rinse with water. For other body fluids, cleanse the visible matter with disposable absorbent material soaked with 0.1% (add one part of household bleach into 49 parts of water) hypochlorite solution. After leaving for 30 minutes, rinse with water. Common housekeeping procedures are adequate for cleaning environmental surface.

Accidents and Dangerous Occurrences

All personnel should be instructed to notify supervisors of accidents and dangerous occurrences especially needle-sticks injuries. All notified accidents should be recorded in a log book specifically kept for this purpose. They should be reviewed and monitored so that corrective and prevention actions can be taken.

Post-Exposure Management

Wound should be thoroughly washed with soap and water before disinfected and dressed. For mucosal contact, e.g. spillage into the eyes, the exposed part should be washed immediately and liberally with running water. The exposed should seek medical advice for risk assessment and proper post-exposure management.

Documentation and Monitoring

The hallmark of good quality control is comprehensive documentation. In addition to specific record retention policies as may be required by individual organizations, the following records should be kept and periodically reviewed:

a. Personnel training program with documentation and record

b. Temperature logs

Daily record of the refrigerator and/or room temperature where test kits and external controls are stored and the temperature of the testing area

c. External control result logs

External control records should include date and time of control testing, lot number and expiration date of test kit, lot number and expiration date of controls, control results, and corrective action taken if control results are unacceptable.

d. Test results logs

Test result records should include date and time of testing, identifier for the person being tested, 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 requested, including the type of specimen sent for confirmation and the confirmatory test results when 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 test results occurring repeatedly with the same test kit lot number.

Quality Control (QC)

The QC test kits are specifically formulated and manufactured to ensure good performance of the test. They are also useful in providing a reference standard for verification of the tester's ability to perform the test and interpret the results in a proper manner.

QC should be run:

When opening a new test kit lot.
Whenever a new shipment of test kits is received.
By each new tester prior to performing testing on patient specimens.
If the temperature of the test kit storage area falls outside 2-27 degree Celsius.
If the temperature of the testing area falls outside 15-27 degree Celsius.
At monthly intervals.

Key QC indicators may include:

Number of tests or QC materials that expired before use, or occurrences of expired tests used for diagnostic or QC purposes.
Number of tests or QC materials that were stored or used outside of temperature specifications.
Frequency of QC testing compared to test site procedure.
Ratio of tests used for diagnostic purposes to tests used for QC purposes.
Frequency of invalid or incorrect results for diagnostic and QC testing.
Proportion of negative and preliminary positive diagnostic test results.
Proportion of rapid test results confirmed positive of all reactive rapid test results.

Significant problems, especially those concerning the accuracy of rapid HIV test in use, should be immediately reported to the appropriate supervisory personnel. The manufacturer should be notified where necessary.

Troubleshooting

Troubleshooting procedures should be made known to all testing personnel and include the following areas:

a. When to discontinue testing, e.g. when the QC results are unacceptable as described in the package insert

b. How to take corrective action, or take action in response to a problem, e.g. contacting the manufacturer when the QC results are unacceptable and following the advice provided

c. How to document problems and actions taken, e.g. a logbook of problems and corrective actions taken to address the problem

d. How to verify the corrective actions taken addressed the problem

e. Expired tests or QC materials:

Evaluate inventory management and storage procedures to ensure materials have a reasonable shelf life
Usage of test and QC materials
If needed, adjust ordering procedures, revise protocols and retrain staff

f. Tests or QC materials stored or used when temperatures are outside the manufacturer's temperature specifications:

Determine the cause for out-of-range temperatures, if procedures were followed, and if testing personnel were aware of temperature conditions
Confirm whether tests were used in out-of-range temperatures, if testing procedures were followed, and if testing personnel were aware of temperature conditions
Determine whether QC tests were performed to verify the test could be performed and correctly interpreted
If needed, modify procedures and retrain staff on temperature control

g. Incorrect or invalid QC test results:

Evaluate procedures for testing external controls and review record of control results
Perform troubleshooting procedures in accordance with the manufacturer's control kit instructions to determine the sources of the incorrect or invalid result
If test devices used with valid external control materials provide invalid or incorrect results, discontinue testing and contact the manufacturer
Resume testing only after tests on external control materials provide correct results and document corrective actions
If needed, modify quality control protocol and retrain staff on appropriate testing.

h. Invalid client test results:

If possible, observe specimen collection, testing and results interpretation to confirm testing procedures are performed correctly
Confirm the test device used had not expired
Review documentation of testing to ensure procedures are followed
Determine external controls were tested after the second invalid test results and if troubleshooting procedures were followed. If not, perform external QC testing using test devices from the same kit or lot to determine proper functioning of test device
Perform troubleshooting procedures according to the manufacturer's instructions
If test results using valid external control materials provide invalid results, testing should be discontinued
If the test kit/ lot is determined to be faulty, notify the manufacturer
Resume testing only after tests on external control protocols provide correct results and document corrective actions
If needed, retrain staff on appropriate testing procedures

i. Excessive false positive client test results:

Evaluate expiration dates of test kits and temperature of storage and testing areas of test kit lots that produced, and did not produce false positive results
Review records of external control testing for test devices of the same lot and subjected to the same temperature conditions
Perform additional troubleshooting procedures in accordance with the manufacturer's instructions
Evaluate facility testing procedures and if appropriate modify protocol and retrain staff on appropriate testing procedures
If necessary, inform the manufacturer. If appropriate, consider discontinuation of testing or changing to another test vendor.

External Assessment

It is recommended for service providers to be visited by an external body to assess the quality of the program on a regular basis. For DH ACTS, ISO accreditation was attained for the operation of AIDS Hotline service in 2001. Subsequently the voluntary counselling service attained ISO accreditation in 2005. DH ACTS receives annual inspection by ISO accreditation agency. Even if ISO accreditation is not feasible due to manpower and resource constraints, it is generally recommended for service providers to consider inviting an external party to inspect the VCT program and provide recommendations for improvement on a regular basis.

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