1. No category

Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 1
TABLE OF CONTENTS
DEFINITIONS
3
SECTION I:
OVERVIEW AND INDICATIONS FOR POC HIV TESTING .................... 8
1.0 BACKGROUND ........................................................................................................ 8
2.0 PURPOSE8
3.0 EPIDEMIOLOGY OF HIV INFECTION IN B.C. ......................................................... 8
4.0 POLICY FRAMEWORK ............................................................................................ 9
5.0 COMPARISON OF POC & STANDARD HIV TESTING ............................................ 9
6.0 POTENTIAL BENEFITS OF POC HIV TESTING .................................................... 10
7.0 POTENTIAL HARMS OF POC HIV TESTING ........................................................ 10
8.0 GENERAL REQUIREMENTS ................................................................................. 11
9.0 INDICATIONS FOR POC HIV TESTING ................................................................. 11
SECTION II:
PERFORMING THE TEST .................................................................... 14
1.0 KEY INFORMATION ABOUT POC HIV TESTING ................................................. 14
2.0 CONDUCTING THE INSTI™ HIV TEST.................................................................. 15
3.0 INTERPRETING THE TEST RESULTS .................................................................. 18
4.0 FOLLOW-UP TESTING .......................................................................................... 20
SECTION III:
QUALITY ASSURANCE ....................................................................... 24
1.0 OVERVIEW ............................................................................................................. 24
2.0 TRAINING
25
3.0 USING QUALITY CONTROL SAMPLES ................................................................ 27
4.0 PERFORMING A QUALITY CONTROL TEST........................................................ 30
5.0 PROGRAM REPORTS AND DOCUMENTATION .................................................. 32
6.0 PURCHASING AND INVENTORY CONTROL ....................................................... 35
7.0 OUTREACH AND MOBILE SITES ......................................................................... 37
SECTION IV:
NON-REGULATED AND ALLIED HEALTH CARE PROVIDERS (NRACP)
FRAMEWORK ....................................................................................................... 39
1.0 PURPOSE
39
2.0 ADVISORY COMMITTEE(S)................................................................................... 41
3.0 RESOURCES AND INFRASTRUCTURE ............................................................... 42
4.0 COMMUNITY READINESS AND MOBILIZATION ................................................. 42
5.0 LINKAGES TO CARE, TREATMENT AND SUPPORT .......................................... 43
6.0 TRAINING AND COMPETENCIES ......................................................................... 43
7.0 KEY MANAGEMENT CONSIDERATIONS ............................................................. 44
8.0 ACCOUNTABILITY AND SUPERVISION OF NRACPs ......................................... 45
REFERENCES ................................................................................................................. 47
APPENDICES
50
APPENDIX I — Summary of Test Properties ..................................................................... 51
APPENDIX II — Roles and Responsibilities ...................................................................... 52
APPENDIX III — Daily Log of Client POC Test Results ..................................................... 60
Suggested Citation: BC Centre for Disease Control. Point of Care HIV Test Guidelines for Health Care
Settings, May 2014, Communicable Disease Control Manual, Chapter 5. BC Centre for Disease Control,
2014. Available from: http://www.bccdc.ca/dis-cond/comm-manual/CDManualChap5.htm.
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 2
APPENDIX IV — Fax Template Form................................................................................ 61
APPENDIX V — Direct Observation Checklist for POC HIV Testing .................................. 62
APPENDIX VI — Training Completion Requirements for Nurses, Physicians, NursePractitioners ...................................................................................................................... 64
APPENDIX VII — Training Competencies for Nurses, Physicians, Nurse-Practitioners ..... 65
APPENDIX VIII — Quality Control Log .............................................................................. 66
APPENDIX IX — Monthly Summary Report ...................................................................... 67
APPENDIX X — Incident Summary Form .......................................................................... 68
APPENDIX XI — Temperature Monitoring Log .................................................................. 69
APPENDIX XII — Practice Guidance for Allied Health – Regulated Health Care Providers 70
APPENDIX XIII — Sample Letter for Colleges................................................................... 71
APPENDIX XIV — Recommended Base-Line Qualification for NRACP HIV POC Testers 73
APPENDIX XV — Competencies for Non-regulated and Allied Health Care Providers ...... 74
APPENDIX XVI — HIV Testing Education for Non-regulated and Allied Health Care Providers
.......................................................................................................................................... 77
APPENDIX XVII — Checklist for New NRACP Sites ......................................................... 80
Contact Information for the BC Point of Care HIV Test Program:
Phone:
604-707-5635
FAX:
604-707-2603
Webpage for Resources:
http://www.bccdc.ca/SexualHealth/Programs/ProvincialPointofCareHIVTestingProgram/d
efault.htm
Suggested Citation: BC Centre for Disease Control. Point of Care HIV Test Guidelines for Health Care
Settings, May 2014, Communicable Disease Control Manual, Chapter 5. BC Centre for Disease Control,
2014. Available from: http://www.bccdc.ca/dis-cond/comm-manual/CDManualChap5.htm.
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 3
DEFINITIONS
Acute HIV infection:
The first 4-6 weeks after infection is a period when a person
often has a high viral load and there is a greater likelihood of
transmitting HIV to others compared with individuals in later
stages of HIV infection. Individuals with acute HIV infection may
test falsely negative on HIV tests if they are tested within the
window period.
Community Health
Representative (CHR)
Health care providers or “care providers” (PHAC, 2013) working
in First Nations communities but employed by an external
agency or the health authority.
Confirmatory Test
Venous blood sample sent to the laboratory to confirm a
reactive HIV POC test result. The standard laboratory HIV Test
Algorithm is applied to the sample. The resultant laboratory
report is compared to the POC test result. Discordant results are
flagged, and actions taken are recorded in the client history.
Confirmatory results are reported in the HIV POC Program
Monthly Report as one of:
True Positive – POC and lab both reactive
False Positive – POC reactive, lab – non-reactive
Preliminary Positive – Confirmatory test NOT DONE
Controls
Each INSTI test kit membrane contains an internal/IgG control
that should create a blue dot for each test. This indicates that
enough sample and reagents were added so that if HIV
antibodies are present in the sample, they should turn the “test
dot” blue.
Quality Control (QC) materials are external controls that are
used to test the test system (test kits, tester and light) when the
test system may have been challenged, and assurance is
needed that test results are accurate. They test specifically for
HIV negative, anti-HIV-1 and anti-HIV-2. The positive controls
are intentionally weak to simulate an early infection (low
antibody levels) – a critical point that all testers must be able to
see.
False Negative:
DEFINITIONS
A false negative result is reported when the POC test fails to
detect a HIV infection. Since the BC Program does not include
parallel blood testing with POC, such findings are discovered
only when standard HIV laboratory tests are run and reported
back to the test site. The most common reason for not detecting
HIV is because the client is in early acute phase, and has not
produced antibodies at sufficient levels that they can react with
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 4
the test material, and be detected by the tester. Underlying
medical conditions that affect antibody production, long-term
antiretroviral therapy and HIV-1 group N subtype infections may
also result in a false negative result.
False Positive:
A false positive result is reported when the result for
confirmatory testing is “not indicative of HIV infection”, but the
POC result was reactive or indeterminate. Such results occur
more commonly if there is a low prevalence of HIV infection in
the population being testing (i.e. general population). Factors
that may cause a false positive include recent viral infection,
recent vaccination for viral infections, underlying immune
conditions, cross-reacting antibodies of other origins. Since
there is only 1 POC manufacturer in Canada, subsequent HIV
testing should be by standard laboratory testing.
Health care provider:
(As per the Health Professions Act) An individual from a
profession in which he or she exercises knowledge, skill, and
judgment in, or provides a service related to, the preservation or
improvement of the health of individuals, or the treatment or
care of individuals who are injured, sick, disabled, or infirm.
See Non-regulated Care Provider, Regulated Allied Health Care
Professional, Community Health Representative.
High HIV transmission
activities:
Activities that are associated with increased transmission or
acquisition of HIV include: unprotected vaginal or anal sex; sex
with an HIV infected person; sharing injection –drug-useequipment; sharing unprotected insertive sex toys; and
acquisition of other sexually transmitted infections.
High prevalence
populations:
Groups that have a higher incidence and prevalence of HIV
infection in B.C. include men who have sex with men (MSM),
people who use injection drugs, Aboriginal persons,
incarcerated populations, sex workers and their clients.
Lot number:
The lot number is the 6-digit number which appears on the label
on the outside of each box of 24 test kits. When discussing a
box of test kits, only the lot number on the outside of the box is
to be used.
Non-Regulated Care
Providers (NRCPs):
Care providers who are not regulated by a regulatory body /
College falling under the Health Professions Act (BC Laws
1996).
This may include community outreach workers, community
health workers, peers, care aids and non-regulated counselors,
etc.
DEFINITIONS
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 5
Point of Care (POC) HIV test
KIT
The supplies provided by the manufacturer to do one HIV test
by Point of Care. These supplies include fingerpoke supplies, 1
test membrane, 1 each of solutions 1, 2, 3.
Point of Care (POC) HIV
test:
POC HIV tests (or rapid HIV tests) are screening tests for
antibodies for HIV. These tests are licensed by Health Canada
for use by health care providers in clinical or laboratory settings,
typically providing results within minutes.
Point of Care HIV Test Site:
Location supported by and meeting the expectations of the BC
Point of Care HIV Test Program and the geographic Health
Authority within which the site is found. Such sites are provided
with publically-funded resources and support to provide HIV
tests by Point of Care to clients in their communities.
Point of Care Site Lead:
The individual with the overall responsibility for ensuring that:
the quality and technical aspects of POC HIV testing are
conducted at each site; the ordering of test kits and supplies is
completed; and the monthly reporting and ongoing training and
competencies of staff are maintained.
Point of Care HIV Test,
Invalid result:
An invalid interpretation is made when the IgG/control dot does
not turn blue, or cannot be seen against the background. This
result indicates that there is a problem either with the testing
process, the control material, or the testing device. Often this is
the result of an insufficient blood sample. Another POC test
should be attempted on the client, correcting the original
problem. If this repeats a second time, send a venous sample
for laboratory HIV testing, and run QC to ensure the test kits are
accurate.
Point of Care HIV Test,
Indeterminate result:
A test result where there is only a blue ring around the test dot
area, rather than a full blue dot, as is expected if the reaction is
reactive. Treat as if the result is reactive, and counsel based on
the results of the confirmatory test. Indeterminate results may
be an indication of early HIV infection or may be a false positive.
Point of Care HIV Test,
Non-reactive result:
If a client’s point of care HIV test is non-reactive (negative), it
is considered a final result and further testing is not required.
For clients that may have a higher likelihood of being acutely
infected with HIV and may be in the window period, standard
HIV testing should also be offered (as standard testing has a
higher sensitivity for detection of acute HIV infection).
DEFINITIONS
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 6
Point of Care HIV Test,
Reactive result:
If a client’s POC HIV test result is reactive, it is considered a
“preliminary positive”. A venous blood sample must be
collected for confirmatory testing by standard HIV testing. All
reactive results are reported to the local Medical Health Officer
or Designated Nurse.
Preliminary Positive
A reactive POC result is considered to be preliminary positive, is
reported to the MHO or Designated Nurse, and is confirmed by
standard HIV laboratory testing.
A final result is reported as “preliminary positive” if the result has
NOT been confirmed by standard HIV laboratory tests.
Proficiency Test (PT)
A high-level Quality Assurance activity that involves a group of
testing sites performing the same test on the same unknown
samples(s). Results are analyzed for all results and the resultant
report compares the site performance to the group.
Quality assurance (QA):
All planned and systematic activities implemented within the
quality system that can be demonstrated to provide confidence
that a product or service will fulfill the requirements for quality.
Quality control (QC):
The activities undertaken to verify the accuracy of a test result
or the operational techniques and activities used to fulfill
requirements for quality. Quality control materials (also referred
to as quality control samples or “triplet”) are to be tested to
ensure each lot of POC HIV test kits is reacting and performing
as expected, and to assess that a tester can see the colour
reaction of a weak positive, under the test environment lighting
levels.
QC “Triplet”:
The set of vials needed to complete one QC test. The set
consists of 1 HIV-negative, 1 HIV-1 positive and 1 HIV-2
positive vial. All 3 vials must be tested at the same time to
assess performance of the test kit, tester and testing
environment.
Regulated allied health care
professionals:
Professionals for whom HIV testing does not traditionally lie
within scope of professional practice (e.g., non-physician, nonregistered nurse).
This may include dentists, pharmacists, chiropractors,
physiotherapists, massage therapists, occupational therapists,
dietitians, social workers, etc.
DEFINITIONS
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 7
Standard HIV test:
Standard HIV testing requires collection of a venipuncture
sample for laboratory-based testing, which is a two-step
protocol combining screening (i.e., enzyme-linked
immunoassay, EIA) and confirmatory (i.e., Western Blot) testing.
The result of standard HIV testing is considered final.
Turnaround time for test results is typically within one week.
Test Results
See Point of Care Test Definitions, Confirmatory Test, False
Positive, False Negative, Preliminary Positive
Tester
Individual who does HIV POC tests. This person is aligned with
a HIV POC site, and meets site, Health Authority and Provincial
Program training and competence requirements.
Trauma Informed Care
Trauma Informed Practice
Interpersonal trauma will be defined as experiences involving
disruption in trusted relationships as the result of violence,
abuse, war or other forms of political oppression, or forced
uprooting and dislocation from one’s family, community,
heritage, and/or culture.
True Positive:
A true positive result is reported based on confirmation of a
POC reactive or indeterminate result by standard HIV laboratory
test results.
Voluntary HIV testing:
A confidential process that allows a person to discuss HIV
acquisition and transmission with his or her health care provider,
to decide whether to be tested, and to receive follow-up support
upon receiving test results. Voluntary HIV Testing includes both
provider- and client-initiated testing.
Window period:
The time between infection with HIV and the detection of HIV by
a diagnostic test. The window period may vary between different
HIV test products or protocols.
DEFINITIONS
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 8
SECTION I:
1.0
OVERVIEW AND INDICATIONS FOR POC HIV TESTING
BACKGROUND
Point of care (POC) HIV tests (also known as “rapid” HIV tests) are screening tests for HIV
antibodies which can be performed on-site while the client waits, and provide results within
minutes. If reactive, the result is preliminary only and needs to be confirmed using standard
serology. In Canada, one POC HIV test product has been licensed for use in health care
settings: the INSTI™ HIV-1/HIV-2 Rapid Antibody Test (bioLytical Laboratories; hereafter
referred to as the INSTI™ HIV Test). For more detailed information about this product, please
refer to Appendix I – Summary of Test Properties.
In August 2010, the B.C. Centre for Disease Control (BCCDC), an agency under the Provincial
Health Services Authority (PHSA) was asked by the B.C. Ministry of Health to introduce a
centralized, province-wide HIV point of care (POC) testing, distribution, and quality assurance
program. This program is funded through a provincial program, Seek and Treat for the Optimal
Prevention of HIV/AIDS (STOP HIV/AIDS). Through this program, BCCDC supplies POC HIV
test kits to the regional and First Nations health authorities, to support HIV testing at designated
POC testing sites.
2.0
PURPOSE
The purpose of this manual is to provide guidance regarding the implementation and use of
POC HIV testing in B.C. for approved sites in order to maximize the quality of POC HIV testing
both within each site implementing POC HIV testing and for the province overall.
This manual outlines guidelines for programs or sites adopting POC HIV testing. Included in this
manual are recommendations and procedures for the appropriate use of POC HIV test kits; and
quality assurance components required for use with POC HIV test kits, such as staff training,
documentation, purchasing and inventory control.
This manual does not address pre- and post-test discussions
surrounding POC HIV testing; these are separate guidelines located in
Chapter 5 of the Communicable Disease Control Manual and can be
found at www.bccdc.ca.
These guidelines are broadly applicable to any site in B.C. offering POC HIV testing. Some
sections, such as purchasing and inventory control, and reports and documentation, are specific
to sites receiving POC HIV test kits through the provincial program.
3.0
EPIDEMIOLOGY OF HIV INFECTION IN B.C.
The number of HIV tests performed in B.C. continues to increase. In 2013, 258,964 HIV tests
(venal blood draw) were conducted. Of the 258,964, 19% (n=49179) were prenatal. In addition,
10,254 POC tests were performed in 2013.
The highest number of new positive HIV test results is reported in men who have sex with men
(MSM), heterosexual populations, and people who use injection drugs (IDU). Aboriginal persons
SECTION I: OVERVIEW AND INDICATIONS FOR POC HIV TESTING
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 9
are over-represented among new positive HIV tests, particularly Aboriginal females. For the
most recent data on recent trends in new positive HIV tests in B.C., please see the Annual
Surveillance Reports (at http://www.bccdc.ca).
The Public Health Agency of Canada (PHAC) estimates that in B.C. in 2008, there were
between 280-540 incident HIV infections (of which 50% were MSM, 25% were IDU, and 21%
were heterosexual from non-endemic countries). The prevalence of HIV in B.C. was estimated
at 11,400 persons (range 9,300–13,500 persons), of which 50% were MSM, 25% were IDU, and
25% were heterosexual. Nationally, an estimated 26% of HIV positive persons are unaware of
their infection.
4.0
POLICY FRAMEWORK
Common objectives among HIV-related strategies in B.C. are the prevention of new HIV
infections, reducing the number of HIV positive individuals who are unaware of their HIV status,
and linkage of HIV positive individuals to care, treatment, and support services.
Expansion and increased availability of HIV testing is one strategy identified in B.C. at provincial
and health authority levels to help achieve these objectives, and is a critical component of the
STOP HIV/AIDS Program. Expansion of testing is considered one component of comprehensive
HIV-related services, generally with emphasis on regional populations with a higher prevalence
of HIV infection, and as a means of connecting people with HIV to appropriate care and support.
Expansion of testing into rural and remote communities has also been identified as a priority.
Other common themes include the importance of pre- and post-test discussions, and integration
of HIV testing with testing for Hepatitis C (HCV) and other sexually transmitted infections.
Testing to prevent perinatal transmission of HIV, and to a lesser extent occupational
transmission of HIV, is also identified.
National strategies endorse HIV testing accompanied by pre and post-test discussions as an
effective early intervention (by linkage to care) and an effective prevention strategy (by
supporting the reduction of transmission in individuals with positive HIV tests).
Three key elements must accompany HIV testing.
Testing must be:
 confidential,
 accompanied by pre- and post-test discussions, and
 conducted with informed consent.
5.0

COMPARISON OF POC & STANDARD HIV TESTING
The INSTI™ HIV Test has similar sensitivity and specificity compared to standard HIV
screening tests (Sensitivity, Specificity > 99%). While a non-reactive (negative) result is
considered final (unless the person is tested early during the phase of acute infection and
is in the window period), false reactive (positive) results can occur. False reactive results
are more likely in a setting with a low prevalence of HIV (e.g., a setting where the
population being tested for HIV has a low risk of infection).
SECTION I: OVERVIEW AND INDICATIONS FOR POC HIV TESTING
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 10

With standard HIV testing, confirmatory testing immediately follows positive screening
tests in the lab and the result returned to the patient is final. With a reactive POC HIV test,
the result is conveyed to the client as a preliminary result, and collection of a blood sample
by venipuncture for confirmatory testing is required in order to provide the client with a final
result at a later date.

With standard HIV testing, a follow-up visit is required for receipt of results. The same
applies to POC HIV testing if the result is preliminary reactive; however, if the POC HIV
test is non-reactive, a follow-up visit is not required (if the client is outside of the window
period).

An individual with a non-reactive POC HIV test may be in the window period (i.e., prior to
the development of a strong antibody response). Standard HIV screening tests are more
sensitive than the INSTI™ HIV Test for detecting acute HIV infection, due to window
period differences (see page 18 for more information).

Typically, testers find POC HIV tests to be easy to use.

Unlike machine-read results for standard HIV testing, interpretation of POC HIV tests is
subjective. Inter-reader variability in test interpretation is low, although variability may be
greater in early HIV infection when a reactive result may be faint and difficult to see.

Unlike standard HIV testing, the tester and site administering the POC HIV test assumes
the responsibility for quality assurance activities to ensure that the test is carried out
correctly.

With standard HIV testing, positive HIV results are reported to public health for partner
notification through a routine, established surveillance system. With POC HIV testing, all
reactive POC HIV test results are to be reported to Medical Health Officer or Designated
Nurse by the tester/site.
6.0





7.0
POTENTIAL BENEFITS OF POC HIV TESTING
POC HIV testing is highly acceptable to, and preferred by, many clients presenting for
testing as well as testers.
Use of POC HIV testing may increase uptake and volume of HIV testing.
Individuals undergoing POC HIV testing will receive their POC test result, particularly if
they are HIV negative. Receipt of a final HIV positive result may not differ from standard
testing, although individuals may be more likely to return for receipt of confirmatory test
results.
The rapid turnaround time associated with POC HIV testing can guide urgent decisionmaking to prevent transmission of HIV infection or to improve patient care.
POC HIV testing may be a viable testing option for individuals where venipuncture is
difficult or has been unsuccessful.
POTENTIAL HARMS OF POC HIV TESTING
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Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 11




8.0
POC HIV testing may lead to decreased uptake of testing for other infections (e.g.,
Hepatitis C, syphilis).
As POC HIV testing is not laboratory-based or automated, there may be greater potential
for user error or other site-specific factors to influence the quality of testing.
Increased incidence of subsequent sexually transmitted infections has been reported in
clients getting a POC HIV test in comparison to clients testing through standard protocols,
possibly due to dis-inhibition on receipt of a non-reactive test result or compression of preand post-test discussions into a single visit.
With POC HIV testing there may be missed opportunities for partner discussion and
referral (and prevention of further HIV transmission) if clients are lost to follow-up after
receipt of a reactive result without confirmatory testing.
GENERAL REQUIREMENTS
The following are general requirements for locations adopting POC HIV testing. Detailed
information is found in Appendix II (Roles and Responsibilities). A Readiness Checklist is
available on the Provincial Program webpage.








9.0
POC HIV testing is confidential, accompanied by pre and post-test discussions, and
conducted with informed consent.
Testing is conducted by providers who have been trained to deliver HIV pre- and post-test
discussions and how to use POC test kits.
Recommended quality assurance measures are in place (e.g., training/competence,
documentation, monitoring of test outcome, use of quality control test kits, etc).
Where feasible, clients presenting for HIV testing should be offered a choice of standard or
POC HIV testing.
Clients are encouraged to test for other infections as appropriate (e.g., HCV, syphilis).
Capacity exists within the testing framework to provide additional support to clients and
providers at the time of a reactive POC HIV test and to facilitate standard confirmatory HIV
testing.
Providers have knowledge of local care pathways and community resources available to
clients who test positive for HIV.
Reactive POC test results are reported to the local Medical Health Officer or Designated
Nurse by the tester/site.
INDICATIONS FOR POC HIV TESTING
This section provides guidance regarding the appropriate use of POC HIV testing in B.C. In
particular, this section suggests clinical scenarios and voluntary HIV testing settings where POC
HIV testing is most indicated. These indications are based on the current epidemiology of HIV
transmission in B.C., current policy frameworks for HIV testing, and a review of the evidence of
impact and use of POC HIV testing.
Information on expansion to Non-regulated or Allied Health Providers as testers can be found in
Section IV, but Sections I to III apply to all sites and testers.
9.1
Clinical Scenarios Where There is an Urgent Need to Determine HIV Status
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As with standard HIV testing, providers need to use best practice judgment based on the history
of risk exposure, potential for acute or early infection, and knowledge of the POC HIV test
window period when acting on the result of POC HIV tests.
9.1.1
Pregnant women near term or in labour with undocumented HIV status or ongoing risk of
HIV infection in pregnancy
The risk of transmission from a mother with HIV infection to her infant is substantially
reduced if antiretroviral medications are administered to the mother during pregnancy,
labour or delivery or to the infant shortly after birth. POC HIV testing of women near term
or in labour with undocumented HIV status or ongoing risk of HIV infection provides an
enhanced opportunity for rapid identification of HIV infection and initiation of antiretroviral
therapy to reduce the risk of HIV transmission to the newborn.i
9.1.2
Testing of the source individual during blood and body fluid exposures
Knowledge of the HIV status of source individuals during the evaluation of blood and
body fluid exposures can guide decision-making regarding the administration of postexposure prophylaxis. POC HIV testing of source individuals reduces the time to result
availability and may avoid unnecessary post-exposure prophylaxis and anxiety in the
exposed person.ii
9.1.3
Clinical diagnosis of acutely ill patients
Patients may present for emergency care where rapid knowledge of HIV status may
improve quality of care by guiding further diagnostic workup or treatment (e.g., patients
with a clinical presentation compatible with opportunistic infections).
9.2 HIV Testing Settings
There are no set criteria for determining whether POC HIV testing should be offered in a
specific HIV testing setting (broadly defined to include clinics, outreach programs, needle
exchanges, etc). Rather, sites should be determined by Regional Health Authorities and
First Nations communities according to local priorities for expanding and engaging
populations in HIV testing, and with consideration at a regional level of sites where the
potential benefits of POC HIV testing outweigh the potential harms (section 6.0, 7.0
above). A further consideration is whether voluntary testing settings have the
infrastructure and resources required to adopt POC HIV testing (section 8.0 above;
Appendix II).
Examples of voluntary HIV testing settings where POC HIV testing is expected to have
the most benefit include:
i
Refer to Oak Tree Clinic, B.C. Women’s Hospital and Health Centre for guidelines regarding HIV testing and
management in pregnancy (www.bcwomens.ca/Services/HealthServices/OakTreeClinic/default.htm)
ii
Refer to BCCDC guideline “Blood and Body Fluid Exposure Management (March 2010)” in the CD Control Manual
(www.bccdc.ca)
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Point of Care HIV Test Guidelines for Health Care Settings
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9.2.1
Settings accessed by populations where the prevalence of undiagnosed HIV is expected
to be higher
Compared to sites in the region offering standard HIV testing, POC HIV testing may lead
to increased uptake and volume of HIV testing. Use in these settings where the client
population is known or suspected to have a higher prevalence of undiagnosed HIV may
contribute to reducing the proportion of HIV positive individuals who are unaware of their
HIV status.
9.2.2
Settings accessed by populations where not returning for test results is common among
those tested
Receipt of a positive HIV result has been demonstrated to lead to a reduction in risk
behaviour. POC HIV testing has been demonstrated to improve the receipt of final test
results. In settings where a high proportion of clients are tested and do not return to find
out their test results, POC HIV testing may be of benefit, particularly where failure to
return is common among HIV positive individuals.
9.2.3
Settings accessed by populations where provision of a POC HIV test result will improve
public health follow-up or connection to HIV clinical care
For example, presentation for medical care, admission to facilities, or other services may
provide opportunities to engage individuals in testing. However, as the tester may not be
the patient’s primary health care provider, and rapid patient turnover within facilities is
common, receipt of test results, follow-up by public health of positive results, and
connection to HIV care may be difficult. In such settings, POC HIV testing with
immediate identification of individuals with reactive HIV results may improve follow-up
and connection to care.
9.2.4
Settings accessed by populations with low rates of testing where POC HIV testing may
lead to increase uptake of testing
The convenience and ease of testing due to rapidity of result, and requirement for a
single visit (if negative) may be appealing and lead to increased test uptake. This must
be balanced by the increased cost of this test and by the expectation of increased
numbers of false positive results in a no-or low-risk population. POC may reduce the fear
of confidentiality breach that may occur in small, remote or isolated communities.
SECTION I: OVERVIEW AND INDICATIONS FOR POC HIV TESTING
Communicable Disease Control Manual – Chapter 5
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Page 14
SECTION II: PERFORMING THE TEST
1.0








KEY INFORMATION ABOUT POC HIV TESTING
The INSTI™ HIV Test is used to screen for HIV antibodies in whole blood.
POC HIV testing is confidential, accompanied by pre and post-test discussions, and
conducted with informed consent. Guidelines for pre- and post-test discussions to
accompany POC HIV testing are located in Chapter 5 of the Communicable Disease
Manual (www.bccdc.ca).
Where feasible, clients should be offered a choice of standard or POC HIV testing. Clients
should also be encouraged to test for other infections such as syphilis or Hepatitis C as
appropriate.
Providers should have knowledge of local care pathways and community resources
available to individuals who test positive for HIV.
Quality Control testing of POC HIV test kits should be conducted according to
recommendations (see Section III — Quality Assurance) prior to offering POC HIV testing.
Any indication that POC HIV test kits are not performing properly should be reported to the
POC Site Lead, the Provincial POC HIV Testing Program and the manufacturer.
All test results and other relevant information such as lot number and expiry date, should
be documented (see Section III — Quality Assurance).
If a client’s POC HIV test result is:
reactive
This result is considered to be a “preliminary positive”.
A venous blood sample must be collected to confirm the POC HIV test
result for confirmatory testing by standard HIV testing.
All reactive results are to be reported to the local Medical Health
Officer or Designated Nurse and a plan should be made with the client
to return for the confirmatory result.
non-reactive
This result is considered a final result and further testing is not
required.
For clients who may have a higher likelihood of being acutely infected
with HIV and may be in the window period, standard HIV testing should
also be offered (standard testing has a higher sensitivity for detection
of acute HIV infection).
Invalid
This result cannot be reported. The test should be repeated with a
fresh sample using a new membrane unit, kit components, and support
materials.
If the client has a second invalid result, standard HIV testing should be
performed, Quality Control materials should be tested, and the POC
Site Lead notified.
Indeterminate
A venous blood sample must be drawn and forwarded to a laboratory
for HIV standard testing.
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May 2014
Page 15
2.0
CONDUCTING THE INSTI™ HIV TEST
2.1
Test Schematic
CENTREWELL
TEST
MEMBRANE
2.2
Flow Diagram for HIV POC Testing During a Client Visit
Provide pre test
discussion
Perform the POC
test
Read test result
Yes
Negative Test
(non-reactive)
Positive Test
(reactive)
Indeterminate
Test
Invalid Test
Post test discussion
No
Window
period?
Repeat with new
sample and test
kit
Yes
Provide post test
discussion
Client visit
concluded
Complete requisition
and draw venous
blood
Schedule follow up
appointment
Wait for test result
Provide post test
discussion
SECTION II: PERFORMING THE TEST
No
Second test
valid?
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May 2014
Page 16
2.3
Procedure for Conducting the INSTI ™ Test
Prior to conducting the POC HIV test, check that the POC HIV test kits have not expired, and
that quality control testing has been done as per the guidelines in Section III 3.0.
Prepare for
testing.
1.
Wash or sanitize hands.
2.
Prepare a testing area by disinfecting a non-porous level surface with an
approved disinfectant. Note: Alternately a new, clean, blue pad may be
utilized to contain the testing materials.
3.
Gather the following materials:
 INSTI™ HIV Test kit, which contains:
 HIV test membrane
 each of reagent solutions 1, 2 and 3
 alcohol swab
 single-use lancet
 single-use pipette capable of dispensing 50 uL
 gloves
 gauze or cotton ball for post-puncture wound coverage
 biohazard sharps/waste container
4.
Select the finger to use for obtaining the blood sample.
Note: Avoid using the index finger or thumb because these two fingers
are usually more calloused than the other three fingers. Similarly, avoid
the tip of the finger.
5.
Massage and/or warm the selected finger to allow blood to flow to the
surface.
6.
Open alcohol swab and the Solution 1 vial (do not discard the lid).
7.
Open the pouch containing the membrane unit.
8.
Remove the test membrane from the pouch without touching the centre
well. Position the test membrane on the level surface with the tab down
(facing you).
Note: If the centre well is touched, the HIV antigen molecules will be torn
from the membrane and the test will not perform correctly.
9.
Collect
finger prick
Put on gloves.
10. Wipe selected warmed finger thoroughly with alcohol swab and position
hand at waist level or lower. Allow alcohol to dry before proceeding.
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Communicable Disease Control Manual – Chapter 5
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Page 17
blood
11. Twist off the protective cap from the lancet and then pull the cap straight
off.
12. Position the lancet device against the finger. Holding lancet body, press
the lancet firmly against the finger.
13. Dispose the lancet directly into a sharps container.
14. Hold the pipette horizontally and touch the tip of the blood drop to the tip
of the pipette. Note: The pipette will fill by capillary action; do not
squeeze the pipette during filling.
15. Fill the pipette to the fill line to obtain the required amount. Note: It is very
important to draw the correct amount of blood. If the puncture site does
not yield a sufficient amount, a separate second puncture using a new
lancet and pipette is required.
16. Place gauze over the puncture site and ask the client to hold it against
the puncture site and to elevate the hand.
17. Transfer the blood from the pipette into the sample diluent (Solution 1)
vial by squeezing the bulb of the pipette to dispense the blood into the
vial (figure A). Note: If the blood does not expel from the pipette, hold the
pipette vertically and slide a finger over the vent hole and squeeze the
pipette bulb (figure B).
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18. Dispose the pipette in a biohazard waste container.
19. Recap the vial (Solution 1 + sample), mix by turning upside down a few
times. Note: Do not shake vigorously. Complete each of the following
steps immediately.
Testing –
Using
solutions 1,
2, 3
20. Carefully pour the entire contents of the Solution 1 vial into the
membrane well.
Note: If most of the solution has gone into the well but some has dripped
on the side of the vial, continue the test. If the control dot appears the test
can be interpreted. The test is built to ensure sufficient sample has been
added when the control dot appears.
21. Wait until the solution is absorbed by the membrane (takes only a few
seconds).
22. Mix the Colour Developer (Solution 2 vial) by slowly turning the vial
upside down several times.
Note: This solution should appear evenly suspended prior to adding to
the membrane.
23. Open and add the entire contents of the colour developer (Solution 2) to
the centre of the membrane unit. Wait until the solution is absorbed by
the membrane (takes approximately 20 seconds).
24. Open and add the clarifying reagent (Solution 3 vial) to the centre of the
membrane unit.
Interpret
the results
25. Read the result immediately and record the result.
Clean up.
26. Discard the test membrane in a biohazard waste container.
Note: If more than 5 minutes have passed since adding the clarifying
solution (solution 3) the result is invalid.
27. Remove and discard gloves.
28. Decontaminate the work area with an approved disinfectant.
3.0
INTERPRETING THE TEST RESULTS
3.1
Procedure
1. Review the flowchart in Section II 2.2 (Flow Diagram for HIV POC Testing during a Client
Visit) for information on interpreting the test result.
2. Read the test with the tab in the lower position from the membrane.
3. Interpret the test according to the instructions in the table on page 15.
4. Interpret the test and convey the result to the client.
5. Record the test result as per instructions in Section III, 5.1.
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3.2
Table: Interpretation of HIV Point of Care Test Results (INSTI™)
Result
If the membrane shows:
Interpretation:
Next Steps:
Non-reactive
(negative)
Only one blue dot at the top (farthest
from the plastic tab):
Test is valid
Result is final.
Antibodies to
HIV-1 and HIV-2
have not been
detected
If client has signs or
symptoms of acute HIV
infection, blood sample
should be drawn and sent for
standard HIV testing.
Test is valid
A venous sample must be
drawn and sent for standard
HIV testing (to confirm the
result and to rule out the
possibility of a false positive
result).
Reactive
(preliminary
positive)
Two blue dots appear, one above the
other (one dot may be darker than the
other).
Antibodies to
HIV-1 or HIV-2
have been
detected
Report reactive result to local
Medical Health Officer, or
Designated Nurse.
Indeterminate One blue dot at the top. Faint
background ring appears on the lower
test dot.
Invalid
No blue dot at the top of the membrane;
or blue specks appear; or
there is a uniform blue colour across the
membrane.
Test is valid
Antibodies to
HIV-1 or HIV-2
may have been
detected
Test is invalid
Something may
be wrong with
the test kit or the
testing process
A venous sample should be
drawn and sent for standard
HIV testing.
Treat as a reactive result.
Repeat with a fresh sample
and new test kit making sure
that sufficient sample has
been collected for testing.
If the second test is also
invalid, a venous sample
should be drawn and sent for
standard HIV testing. Report
invalid resultsX2 to POC Site
Lead, and Program Lead.
Use quality control samples
to make sure that the test is
operating properly.
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Communicable Disease Control Manual – Chapter 5
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Page 20
3.3







3.4
Notes and Limitations
The control dot may be darker or lighter than the lower, client/test dot.
When there is a problem reading the test (e.g., shadows or rings), then two individuals
should read the test, if possible. The names of both people reading the test(s) should
be documented. Remember that results read more than 5 minutes after the addition of
solution 3 are considered to be “invalid”.
When more than 60uL of blood is used, the flow through the membrane may be slowed
and produce a uniform blue colour across the entire membrane (an invalid result). It is
extremely important to use the supplied capillary pipette to add the sample to solution 1.
A client in the window period may have a false non-reactive test result. Clients who are
more likely to be in the acute phase of HIV infection (i.e., have high likelihood of HIV
infection) should be encouraged to have blood drawn for standard HIV testing at the
same visit.
A test that is performed using an insufficient sample, performed incorrectly or where a
defective device is used, will give an invalid result and testing should be repeated. If
the second POC HIV test performed is also invalid, quality control samples should be
used to determine if the test kits are performing correctly. Notify the POC Site Lead and
the Program after two consecutive invalid results. Venous blood samples should be
drawn and sent to BCCDC for standard laboratory HIV testing.
False non-reactive (negative) or invalid test results may be obtained from clients with
hypogammaglobulinemia conditions (e.g., multiple myeloma), patients receiving
HAART, and patients with elevated hemoglobin. Patients receiving HAART should not
require POC testing. For patients with hypogammaglobulinemia, RNA or HIV
antigen/antibody testing may be required.
The INSTI™ HIV test has not been validated for detection of antibodies to HIV-1 Group
N sub-group.
Further Information
Please contact the Provincial POC HIV Testing Program for further information about the
test, interpretation of test results, or troubleshooting.
4.0
FOLLOW-UP TESTING
It is essential to confirm all reactive or indeterminate POC HIV test results with standard
laboratory HIV testing. In addition, a confirmatory lab sample should be drawn and sent for
testing if a test results in two consecutive invalid results.
Clinical judgment remains important in HIV testing. If you receive a “not indicative of HIV
infection” or indeterminate standard HIV test result for a client who you consider to have a
high likelihood of having an HIV infection, you may contact a medical or clinical virologist at
the PHSA Laboratory to review the case and to determine if additional tests are indicated.
Individuals (regardless of POC HIV test result) should be advised to get tested for other
infections via standard blood testing where appropriate (i.e., syphilis, hepatitis B, hepatitis C).
As with standard HIV testing, if the serology done to confirm a reactive POC results in a true
positive result, a second blood test is recommended to confirm the diagnosis. This will help to
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Page 21
eliminate the low possibility of error that might result from sample handling errors such as
mislabeling of submitted samples. Repeat testing is particularly recommended when the
client’s history suggests a low risk for exposure to HIV or the client does not undergo
subsequent viral load testing or connect with HIV primary care follow-up.
4.1
Procedure for Follow-Up Testing
Samples can be collected on-site and transported directly to BCCDC Provincial Health
Microbiology and Reference Laboratory for follow-up testing, or indirectly via another
laboratory. Testing is most often done by the BCCDC lab, but may be referred to another
site, based on Health Authority or site processes.
Detailed instructions and quick reference guides for confirmatory testing are available on the
Provincial HIV POC website.
Contact the Provincial HIV Point of Care Program, if needed.
General Instructions for All Collection Methods:
1. A laboratory requisition must be completed according to established procedure (BCCDC
serology requisition or other), indicating whether HIV testing is to be reported nominally or
non-nominally. Ask the client before including POC test results on the requisition.
2. If samples are collected off-site, then samples will be drawn and sent for testing, based
on the Health Authority HIV testing practices. It is preferred if samples can be sent to the
BCCDC lab, but may not occur.
3. If samples are collected on-site, then draw 1 gold top and 1 EDTA (purple) top tube.
See the appropriate Guide to Lab Servicesiii for current information. All blood samples
drawn and sent for testing must have 2 unique identifiers. Information used on the sample
and requisition must match.
Arrange for the sample to be transported to BCCDC Provincial Health Microbiology and
Reference Laboratory for testing, per established process.
4. When the result of standard laboratory HIV testing is received, record the result in the
client chart and on the Daily Log of Client POC Test Results (Appendix IV). Recording the
result on the client log assists the person who completes the Monthly Inventory Log.
For clients with an initial reactive or indeterminate POC HIV test result, record one of the
following:
iii
Refer to PHSA Laboratories Guide to Programs and Services (http://www.phsa.ca/NR/rdonlyres/D632D3568E8F-4917-BC3D-463EB5F8A14B/0/GuidetoProgramServices.pdf )
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If standard lab test (confirmatory)
result is
Then record the following in client
history and on Client Test Log:
Indicative of HIV infection
(positive)
Not indicative of HIV infection
(negative)
Not done
True Positive (TP)
False Positive (FP)
Preliminary Positive (PP)
Include an explanation/investigation of, or reason for, discordant/differing results in the client
record and on the client test log.
5. Notify the client of their confirmatory test result per site policy.
Additional Steps for Testing Sites Sending Samples DIRECTLY to BCCDC Provincial
Health Microbiology and Reference Laboratory:

Write “STAT” on the upper right corner of the BCCDC requisition, and on any outer
packaging, such as a paper bag or cooler. (This alerts the staff who sort samples and
run the tests that this sample goes first, or to open this container first and send the
STAT sample quickly to the lab.)

If you collect and send a sample directly to BCCDC Lab, then write the POC result in
the Comments section of the BCCDC Serology requisition. Note: This information will
facilitate tracking of test results and may assist BCCDC Laboratory in determining the
appropriate standard HIV tests to perform.

If blood is to be collected or tested elsewhere, then discuss the addition of POC
test results on the requisition with the client, as it may be perceived as a
confidentiality breach if this information is put on the requisition.

Complete the FAX template and send to BCCDC to alert them that a sample is coming
(See Appendix III). This triggers a process in the lab so that they follow-up if the sample
does not arrive when expected. Writing the POC result on the FAX preserves
confidentiality as well as providing additional information to the lab staff.
4.2
Ruling Out Acute HIV Infection
Some clients may be more likely to have an acute HIV infection; for example, individuals with
symptoms of HIV seroconversion, or individuals who are likely to have ongoing or recent
exposure to HIV. For these individuals, following a non-reactive POC HIV test, it is
recommended to submit a blood sample for standard HIV testing.
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A standard HIV test can detect HIV antibodies as early as 2-3 weeks after infection; POC HIV
testing may take a little longer but can detect HIV antibodies as early as 3-4 weeks after
infection.
For both POC and standard testing, approximately 95% of people will have a reactive HIV
test by 6 weeks after infection (>99% by three months). Standard HIV laboratory screening
tests are more sensitive than the INSTI™ HIV Test, due to window period differences. In the
event that a reactive POC HIV test is followed by a negative standard laboratory test, further
testing can be requested by the clinician.
If a recent high-risk exposure has occurred, or acute HIV infection (seroconversion) is
suspected, indicate “query acute HIV” on the test requisition, provided the client agrees.
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SECTION III:
QUALITY ASSURANCE
Non-Regulated or Allied Health Care Providers:
Information in this section applies to all sites, and testers.
Specific information for NRACP is found in Section IV.
Specific Competency and Training Program examples are found as
Appendix documents.
1.0
OVERVIEW
The objective of quality assurance activities is to ensure the delivery of a high quality,
accurate and efficient POC HIV testing process, and to detect/prevent potential errors before
they affect client results. Quality assurance activities must be practiced to ensure that test
results are accurate and as reliable as possible, and to ensure confidence in the testing
program and testers. For this reason, the overall responsibility for the quality and technical
aspects of each site’s POC HIV testing should be assigned to one individual (the “POC Site
Lead”).
In B.C., quality assurance is a shared responsibility between testers, the POC Site Lead, the
Provincial POC HIV testing program, the Health Authority, the PHSA Laboratory, and the
POC HIV test manufacturer (bioLytical).
While test sites (including hospital wards, clinics, outreach programs or other care settings)
are not subject to laboratory accreditation standards, the quality assurance activities
described in this section are based on the manufacturer’s recommendations and follow the
same principles as those found in the Accreditation Canada Standards for Point of Care
Tests (March 2012).
1.1
Reporting Concerns Regarding the Quality of POC HIV Tests
Testers may be the first to suspect issues with the quality of POC HIV test kits, and/or
controls. Potential indications that POC HIV tests may not be performing as expected
include:


Increases in the number of clients with invalid, indeterminate, or false positive results.
Incorrect POC HIV test results with the use of quality control samples.
Any concerns of this nature, including the lot number of the implicated POC HIV test kit or
quality control test should be reported to:
POC Site Lead; and Provincial POC HIV Testing Program Tel: 604-707-5635 Fax: 604707-2603
These reports will be investigated to determine if the issue may be related to an expected
variation or impaired quality of the POC HIV test kit or quality control samples, or to staff
performance (e.g., incorrect procedure).
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2.0
TRAINING
The most important part of the program is to ensure that all HIV POC testers are well-trained
and can confidently perform and interpret the test. Records of training, competency and
proficiency assessments should be maintained and be consistent with existing practice
standards at each site.
2.1
Initial Training for POC HIV Testing
Core HIV education and POC HIV testing training sessions are held regularly by BCCDC and
health authority trainers. Training needs and appropriate mode of delivery are discussed as
part of a new site set-up. For more information, contact the Provincial POC HIV Testing
Program.
Each site/Health Authority must define what additional observations or assessments, beyond
the initial training sessions, must be met before a new tester is approved to offer POC HIV
testing at that site.
Training for POC HIV testing may include a combination of education offered by BCCDC and
by the POC Site Lead as follows:
BCCDC or
Regional
Health
Authorities

Pre- and Post-Test HIV discussion (as needed).

Completion of one 2–3 hour training program on the use of test
kits and quality assurance activities.
POC Site
Lead

Demonstration of competencies (see Appendix V –Direct
Observation Checklist and Appendix VII- Training Completion
Requirements).
HIV POCT online training modules are available through the PHSA Learning Hub.
HIV Education (pre/Post Counselling) is also available online through the BCCDC Learning
Hub.
Training addresses POC HIV testing competencies for testers (please refer to the table in
Appendix VI —Training Competencies). Once training has been completed, each trainee
should independently demonstrate, at a minimum, the competencies described in Appendix
VII —Training Completion Requirements, in the presence of their POC Site Lead.
2.2
Continuing Education and Ensuring Ongoing Competency for Testers
Continuing education and ongoing competency assessment can be done by a variety of
methods and should be scheduled by the POC Site Lead for testers depending on their level
of experience with POC testing.
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Competence assessment is usually done with new testers, and should be repeated at six
months, then yearly as an ongoing assessment. Competence may be assessed more often
for low-volume test sites (< 5 diagnostic tests/month). Competence should include
assessments of counselling skills as well as use of the Point of Care Test.
Possible ways to provide continuing education related to POC and to ensure ongoing
competency for testers are listed below:
1. Interaction with Testers
Informal assessments can be done whenever the
POC Site Lead is at the site, participating in, or
observing, daily activities.
2. Review of daily log of
client POC test results
(Appendix IV) and Quality
Control Log (Appendix IX)
It is recommended that the POC Site Lead review
these documents at a minimum of once a month as an
opportunity to assess how testers are performing and
provide follow up as necessary.
This can be done at the same time as information is
gathered to complete the Monthly Inventory Report.
2.3
3. Direct observation of
tester
It is recommended that refresher training occur
whenever there is a problem or issue identified or on a
regular basis for staff, especially those who do not
perform POC HIV tests regularly (see Appendix V –
Direct Observation Checklist).
4. Regular reviews with
testers in a meeting
setting
Discussions with testers in a meeting setting can
facilitate sharing of experiences with test kit usage
and allow the POC Site Lead to gauge competency
and comfort levels of testers and discuss learning
needs.
5. Investigation of errors
This is an opportunity to assess how testers are
performing based on the findings of an error or nearmiss event. These investigations are also an
opportunity to discuss testing and to review
documents.
6. Proficiency Testing:
See below.
Proficiency Testing
Proficiency Testing (PT) is a higher-level Quality Assurance activity that is conducted two to
three times per year when an external provider sends unknown testing materials to all testing
sites. Each site is expected to test the unknown materials and enter their results into an
online database. Once all the results have been entered, each site will be able to compare
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themselves to other sites (note: names of other sites participating in the PT program will not
be visible to other users) and identify if there are concerns with testing at their site.
Participation in a PT program is an expectation for each site participating in the provincial
POC HIV testing program. It is an important tool that can be used by the site and the
provincial program to verify the accuracy and reliability of POC HIV testing results in order to
protect patient safety. PT differs from Quality Control (QC) testing as it should assess the
entire testing process, involves the testing of unknown samples and anonymously compares
the performance of all sites participating in the program.
The provincial POC HIV testing program will contract the services necessary for PT with an
external provider on behalf of sites affiliated with the provincial program. Costs for PT are
assumed by the provincial POC HIV testing program. The provincial program will be able to
see the results from participating sites, but the identity of individual testers will not be
included in the results database.
3.0
USING QUALITY CONTROL SAMPLES
Quality Control (QC) samples are produced by the manufacturer (bioLytical). QC checks the
stability and function of the test kit, the tester’s eyes and the lighting conditions in which the
test is run. Since the result is a visual colour, it is critical that each tester is able to detect a
weak reactive result and to distinguish between a nonreactive and a weak reactive result in
the lighting conditions of the test environment.
Each box of QC samples contains 36 vials, consisting of an equal number of: anti-HIV-1
positive control, anti-HIV-2 positive control and HIV negative control.





Each vial should be sufficient to conduct to 4-5 tests (144-180 tests total/ box).
The samples are shipped at ambient temperature and should be frozen on receipt by
the site.
The materials will last up to one year if they remain frozen at -20ºC.
Once thawed, they last 28 days when refrigerated at 2-8ºC.
Samples are warmed to room temperature (approximately five minutes) and mixed
before use.
QC samples are made from human sera and should be treated as a biohazard risk, albeit, a
low risk. Sites should follow biosafety rules regarding storage, handling and disposal of QC
samples. Quality control samples should be stored in a freezer in the plastic container in
which they are shipped and enclosed in a biohazard bag. Once thawed, vials can be stored
in a refrigerator in a labeled, leak-proof container.
When used on a regular basis, QC samples provide assurance that the HIV test results being
given to clients are valid and accurate, and can be used to fulfill competence needs.
3.1
Frequency of Use
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It is a Provincial Program expectation that all sites will test QC samples per manufacturer’s
recommendations, but at a minimum of once per month.
If QC fails, the accuracy of results since the last QC success is in doubt. Sites must balance
how often QC samples are tested with the number of clients who would have to be retested
in the event of a problem with the test kits. For sites doing few tests per month (0-25), the
once per month minimum is reasonable as the number of clients that would need to be
retested is minimal. For sites that do many (25 or more) tests per month, regular use of QC
samples may be increased (e.g. once per week).
3.2
Indications for Use of QC Samples
The manufacturer recommends that QC be run at the following times:






for newly trained testers prior to actually using the POC HIV test kit on clients
when a site receives a new shipment of POC HIV test kits
when there is a change in test kit lot number
when a site receives a new shipment of quality controls (usually once per year)
if the temperature of the storage or testing area falls outside of the manufacturer’s
specified temperature range (less than 15°C or greater than 30°C)
when two consecutive invalid results occur with the same client
Indications for when to run QC samples are included at the bottom of the QC Log (Appendix
VIII). It is recommended that the reason for testing should be included on the log to aid the
identification of potential opportunities for improvement.
When QC samples do not provide the expected results and it has been determined that there
is a problem with the test kits, or QC failures are unresolved, none of the tests used since the
last time QC samples were used with correct results can be considered valid. Contact the
Provincial POC HIV Testing Program immediately as client retests, or a product recall,
may be required.
3.3
Overview of the Use of QC
QC assesses the test, the tester’s eyes and the light conditions under which testing is done.
When testing QC samples, use one set of controls “triplet” (one each of anti-HIV-1 positive
control, anti-HIV-2 positive control and negative control) and a separate pipette for each of
the three controls for a total of three POC HIV test kits and 3 QC pipettes. Ideally, a different
tester does QC testing each time, or, at a minimum, the same tester should not always be
conducting the QC testing, so that all testers are comfortable with the process, and testing is
done even in the absence of the “assigned QC tester”. The positive control samples are
intentionally weak positives to simulate a critical point in early infection, where antibody levels
of the client may be barely high enough to be detected by the test kit. It is critical that all
testers are able to see this weak reaction, using the light conditions under which client tests
are done.
When performing QC testing, it is recommended that sites rotate testers each time QC is
done, or follow a “View or Do” model for quality control. The “View or Do” model encourages
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those performing QC testing to show the results to their colleagues so that as many test kit
users as possible have the opportunity to see what reactive and non-reactive results look
like. Using this technique reminds a larger number of testers of the weak positive, without
using a large number of test kits. Contact the Provincial POC HIV Testing Program for
suggestions as to how this may be done at a site.
3.4
Quality Control Failure
When the QC results seen on the test membrane do not agree with the expected result, QC
is determined to have “failed” and an investigation into what caused the problem is
necessary. This event should be reported in the site’s error/accident/corrective action
reporting system.
In the event of a QC failure, record the QC result and inform the POC Site Lead as soon as
possible. Client POC HIV testing must be stopped immediately, until the cause of the failure
is found and corrected.
It is important to review the testing environment for factors that could have caused the QC
failure. Do not continue to use QC samples until you get a “correct result”. It is a good
practice to start an investigation by excluding more-common errors such as mix-up of control
materials, reagents, pipettes and missed steps in the use of QC. Other important areas to
investigate are:
 recent changes to the test or testing environment
 QC storage conditions
 QC expiry date/contamination
 pipette used for testing
3.5
Suggested Actions if QC Fails:
FIRST – assess why the failure occurred, then repeat use of QC samples from the SAME vial
if the assessment suggests a procedural error.
If QC fails again:
repeat test using a FRESH vial taken from the freezer
If QC fails again:
repeat test using a test kit from a newly opened box with the
newly opened QC vial.
if QC fails again
there may be a problem with the test kit lot.
STOP CLIENT TESTING.
Notify the POC Site Lead and the BCCDC POC HIV
Program Lead IMMEDIATELY.
When QC samples do not provide the expected results and it has been determined that there
is a problem with the test kits, or QC failures are unresolved, none of the tests used since the
last time QC samples were used with correct results can be considered valid.
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This means that all clients tested since the last use of QC samples with correct results will
need to be called back and retested (unless a confirmatory test was ordered). A recall of the
test kit or control products may be indicated.
4.0
PERFORMING A QUALITY CONTROL TEST
4.1
Quality Control (QC) Test Procedure (Using INSTI™ HIV POC Test Kit)
Preparation
Prepare test
membrane
Mix samples
1.
Remove one HIV-1 positive, one HIV-2 positive and one negative QC vial
from fridge or freezer and bring to room temperature (approximately 5
minutes).
2.
Document the QC test information (lot number, expiry date) on the
appropriate log. Note: vials expire 28 days after thawing if stored in the
refrigerator.
3.
Wash or sanitize hands.
4.
Prepare a testing area by disinfecting a non-porous level surface with an
approved disinfectant. Note: Alternately a new, clean blue pad may be
utilized to contain the testing materials.
5.
Gather the following materials:
 three INSTI™ HIV Test kits (one for each of the positives and negative
control)
 three quality control pipettes
 gloves
 biohazardous sharps/waste container
6.
Open one pouch containing the first membrane unit.
7.
Remove the test membrane from the pouch without touching the centre well.
Position the test membrane on the level surface with the tab down (facing
you). Note: If the centre well is touched, the HIV antigen molecules will be
torn from the membrane and the test will not perform correctly.
8.
Label the membrane with the type of control (i.e., HIV negative, HIV-1
positive, HIV-2 positive) using a black or blue marking pen and place the
membrane on a level surface.
9.
Put on gloves. Note: All control samples should be handled as if capable of
transmitting infectious diseases.
10. Gently agitate the 3 QC sample vials by inverting, or flicking, a few times. Tap
the bottoms of the vials a few times on a hard surface to bring all the material
from the cap back into the body of the vial.
Pipette a
sample
11. Unscrew the cap of the negative QC sample, and retain it.
Unscrew the cap of solution 1, and retain it.
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Hold both opened bottles in one hand.
12. Squeeze the bulb of the QC pipette very gently to push a small amount of air
out of the pipette (do not use the capillary pipette). Hold the pipette vertically
above the QC vial, lower the pipette into the vial, and then slightly release the
pressure on the bulb to aspirate the QC sample from the vial. Fill the pipette
just to the neck of the bulb. If you pull up sample into the bulb, squeeze
gently to push excess volume out, retaining sample only in the “straight part”
of the pipette.
Solution 1
13. Move the pipette with sample above the opened solution 1 vial. Squeeze the
bulb of the pipette to dispense the sample into solution 1.
14. Discard the pipette in a biohazard sharps/waste container. Recap the QC
vial.
15. Recap
.
the solution 1 vial, mix by inverting the vial a few times. Carefully pour
the entire contents of the solution 1 vial into the membrane well. Wait until the
solution is absorbed by the membrane (takes only a few seconds).
Note: If most of the solution has gone into the well but some has dripped on
the side of the vial, continue the test. If the control dot appears the test can
be interpreted. The test is built to ensure sufficient sample has been added
when the control dot appears.
Solution 2
16. Mix the color developer (solution 2 vial) by slowly turning the vial upside
down several times. Note: This solution should appear evenly suspended
prior to adding to the membrane.
Open and add the entire contents of solution 2 to the centre of the membrane
unit. Wait until the solution is absorbed by the membrane (takes
approximately 20 seconds).
Solution 3
17. Mix, open, and add the clarifying solution (solution 3 vial) to the centre of the
membrane unit. Wait until the solution is absorbed by the membrane (takes
approximately 20 seconds).
Record
results
18. Read the result immediately and record the result. Note: If more than 5
minutes have passed since adding the clarifying solution the result is
considered invalid.
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19. Discard the test membrane into a biohazard sharps/waste container.
Repeat for
HIV-1 control
20. Open and label a new membrane and repeat from step 11 with the second
quality control (HIV-1).
Repeat for
HIV-2 control
21. Open and label a new membrane and repeat from step 11 with the third
quality control (HIV-2).
Clean up
22. Remove and discard gloves.
23. Decontaminate the work area with an approved disinfectant.
24. Check that the lids are tight on all QC vials. Place in labeled container with
the expiry date (28 days after thaw) and store in refrigerator.
5.0
PROGRAM REPORTS AND DOCUMENTATION
Managing the whole POC HIV testing process is critical to its success. It is
recommended that testing sites develop and maintain standard operating procedures related
to POC HIV testing, which are based on these guidelines and consistent with existing
practice standards. These procedures should be reviewed per needs for each tester group;
variant instructions for non-regulated or allied health professionals should be highlighted as
necessary.
Testing sites should retain all POC HIV test records according to their agency’s policy on
retention of clinical records (or a minimum of two years if no such policy exists).
This section outlines the minimum information that needs to be collected for the client, for
quality control testing, and for monthly summary reporting. This information may be recorded
and retrieved in a variety of different formats depending on the testing site (e.g., electronic
charts, paper charts, testing logs). Templates of tools for this documentation are provided in
the appendices of this document. Templates and modifiable versions are available on the
Program webpage.
ONLY the monthly summary report form is sent to the Provincial POC HIV Testing program.
Other documents may be used by the site and the Provincial POC HIV Testing Program for
troubleshooting, in the event of a recall, or in the event of a critical incident such as a quality
control or a proficiency testing failure.
5.1
Documentation of Test Results for POC HIV Tests
If information is manually written, it is recommended that it be as legible as possible.
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For each client undergoing POC HIV testing, the following minimum information should be
documented in the client chart and Client Test Log:
 Date of POC HIV test
 Client identifying information including contact information (2 unique identifiers are
needed). Sites using electronic record-keeping may be able to use a chart number as
identification on the test log. This enables rapid recovery of records should a recall
occur.
 Tester Identification
 POC HIV test lot number and expiry date (found on the outside of the box of 24 kits)
 POC HIV test result (i.e., reactive, non-reactive, invalid, indeterminate)
 Whether a venipuncture for HIV serology was collected (or requisition for HIV serology
given, if sample collection not available on site)
 Standard HIV serology result (i.e., reactive, non-reactive, invalid, indeterminate)
 Final classification of a reactive POC HIV test:
o Preliminary positive (i.e., no standard serology performed, lost to follow-up)
o True positive (i.e., standard serology is reactive)
o False positive (i.e., standard serology is non-reactive)
Testing sites are required to establish processes to:
 Monitor that clients with a reactive POC HIV test result have standard HIV serology
performed, and that these results are received and reviewed by the site and with the
client.
 Follow up when standard HIV serology and POC HIV test results are not the same.
 Rapidly identify all clients tested with a POC HIV test from a specific lot number, or that
have a specific type of POC HIV test result (e.g. non-reactive, reactive, invalid) in case
of a quality issue requiring investigation or re-testing.
 Extract information on key POC HIV test program indicators for reporting on a monthly
basis (see section 5.2 below).
While some testing sites may be able to use existing clinical information systems to meet the
above requirements, an alternate approach is to establish a testing log. This testing log
should be maintained in a central location and be completed for all POC HIV tests conducted
at the testing site, and can be reviewed as required to meet the above requirements. A
testing log template is provided in Appendix III — Daily Log of Client POC Test Results.
5.2
POC HIV Test Monthly Summary Reports
In order to maintain an appropriate regional and provincial supply of POC HIV test kits, and to
monitor the performance of POC HIV test kits at regional and provincial levels, testing sites
are required to provide a monthly summary report to the Provincial POC HIV Testing
Program which includes the following information:


The number of POC HIV test kits (and their expiry dates), in inventory at the start and
end of the month
The number of clients tested by POC HIV test kits:
o Number of clients with non-reactive POC HIV test results
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o




Number of clients with reactive POC HIV test results (total number, and numbers
with final result being true positive, false positive or preliminary positive, based on
standard serologic testing)
o Number of clients with invalid POC HIV test results
o Number of clients with indeterminate POC HIV test results
The number of POC HIV test kits used for quality control testing
The number of POC HIV test kits used for training and proficiency testing
The number of test kits wasted
The number of test kits expired and discarded
This information is to be sent to the appropriate regional health authority contact person(s)
and the Provincial POC HIV Testing Program by the end of the first week of the
subsequent month. A template of a reporting form for this purpose is provided at Appendix
IX — Monthly Summary Report.
5.3
Documentation of Quality Control Results
Testing sites are required to document the results of all quality control tests performed,
including:





The type of quality control material (e.g., negative, HIV-1 positive, HIV-2 positive)
Quality control lot number and expiry date on vial
POC HIV test lot number (on the box of 24 test kits)
POC HIV test result (reactive, non-reactive, invalid)
If the result is invalid, then the log should show that QC was retested and passed.
Inclusion of the reason (or probable reason) for the invalid result is good practice.
This documentation should be maintained in a central place (often kept with the test kits) and
reviewed monthly by the POC Site Lead to ensure that quality control testing is performed at
the recommended frequency (see 3.0 above).
It is recommended that a separate QC Log be kept and that the reason to run QC be
included in the record. This makes it easier for the person gathering information for the
Monthly Inventory Report to assess if an opportunity exists for improvement, or for preventive
action, or if QC is being run at an appropriate level.
5.4
Incident Reporting
Any incident involving POC HIV testing at a testing site should be reported to the POC Site
Lead, according to local practice standards. The purpose of incident reporting is to be able to
monitor and document unexpected or unintended outcomes so that a problem can be
identified and corrected before client results are affected.
Examples of incidents include:
 Unexpected results using quality control samples
 Inaccurate interpretation of POC HIV test results
 Temperature where test kits stored is higher or lower than requirements
 Use of expired test kits, or expired quality control materials
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Testing sites may have established methods for incident reporting that can be used in these
situations. Alternately, an incident log can be maintained to document all POC HIV testrelated incidents, which can be periodically reviewed by the POC Site Lead (see template in
Appendix X). The POC Site Lead may determine that additional support and training may be
required, and are recommended to contact the Provincial POC HIV Testing Program Lead in
this regard.
6.0
PURCHASING AND INVENTORY CONTROL
6.1
INSTI™ HIV Test Kits
Under the Provincial POC HIV Testing Program, the Provincial Program Manager arranges
for the purchase of POC HIV test kits for participating Health Authorities and First Nations
sites in B.C. Costs for these POC HIV test kits are paid from the Provincial Program budget;
orders are placed on a quarterly basis up to an approved allotment. Through the Provincial
POC HIV Testing Program, test kits are ordered in boxes of 24 (i.e., supplies to conduct 24
POC HIV tests). Individually packaged POC HIV test kits are not purchased through the
provincial program.
Regional and First Nations Health Authorities who require more POC HIV test kits than their
allotment will be required to purchase these test kits independently. All questions regarding
ordering POC HIV test kits can be directed to the Provincial POC HIV Testing Program.
6.2
Quality Control Materials and Other Supplies
Costs for Quality control samples and related supplies are paid from the Provincial Program
budget and ordered through the Provincial POC HIV Testing Program as required by each
participating site. Other testing supplies such as extra lancets, quality control storage
materials and temperature monitors can be ordered through the Provincial POC HIV Testing
Program.
6.3
Inventory Control
POC HIV test kits are shipped to participating sites designated by the Regional or First
Nations Health Authority. It is the responsibility of each site/Health Authority or First Nations
Health Authority to reconcile the number of test kits received against the number of tests
performed.
When test kits and quality control samples are received, it is recommended that each site
notify the Provincial POC HIV Testing Program of the following:



Number of POC HIV tests or quality control samples received.
Lot number and expiry dates of test kits and quality control samples.
Status of supplies (i.e. any damage).
Note: POC HIV Kits come in boxes of 24 and each has a lot number and expiry date on the
outside of the box. While the separate components of the test kits each have their own lot
numbers, only the lot number and expiry date on the outside of the box needs to be recorded.
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Unsuitable supplies include those that are expired, improperly stored, or damaged. Contact
the Provincial POC HIV Testing Program to request pick-up/return/disposal of unsuitable
supplies. Please refer to the Returning Unsuitable Supplies table in section 6.4.
6.4
Returning Unsuitable Supplies
Determine the supply destination according to the table below.
If supply involves:
Expired INSTI™ HIV Test kits
or quality control samples
Improperly stored INSTI™ HIV
test kit or quality control
samples
Action:
 Notify the Provincial POC HIV Testing Program with
number and consult to prevent recurrence.

Note: Kits may be transferred to a high use location prior
to expiry through the Provincial POC HIV Testing
Program.

Quarantine the materials at the correct storage
temperature while an investigation is underway.
Report incident to the POC Site Lead and Provincial
POC HIV Testing Program.
Consider this as an opportunity to determine why this
occurred and to prevent reoccurrence.


Defective materials in kits or
quality control samples


Report incident to the POC Site Lead and the Provincial
POC HIV Testing Program.
Save the original material(s) in the event it needs to be
sent to the Provincial POC HIV Testing Program.
Improperly shipped/received or
damaged materials


Report incident to POC Site Lead.
Contact the Provincial POC HIV Testing Program for
instructions on how to proceed.
Recalled INSTI™ HIV Test kits
or quality control samples


Quarantine affected supplies.
Report incident to POC Site Lead and Provincial POC
HIV Testing Program.
Complete recall form and fax to Provincial POC HIV
Testing Program.
Follow Provincial POC HIV Testing Program instructions
for return or disposal.


6.5
Monitoring Storage Temperature of INSTI™ HIV Test Kits
Temperature monitoring is required to ensure that the INSTI™ HIV Test kits are stored
between 15 °C and 30°C. A temperature monitor that measures maximum and minimum
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temperatures over a given period of time should be stored with the POC HIV test kits, and a
temperature monitoring log should be maintained (a sample temperature monitoring log is
provided in Appendix XI).
If the temperature monitor indicates that the ambient temperature has increased or
decreased outside of the specified range, test kits should be moved to an alternate location
for storage and the POC Site Lead should be notified. If test kits have been kept outside of
the recommended temperature range (15 – 30°C) overnight or for extended periods in
unmonitored locations/spaces, it is recommended that kits be quarantined, moved to a
temperature monitored area, quality control samples used and the incident reported to the
POC Site Lead. After using the quality controls and receiving valid results, the kits may be
used for client testing.
7.0
OUTREACH AND MOBILE SITES
The quality assurance recommendations in this section (i.e., use of quality control samples,
training, documentation) apply equally to outreach and mobile sites. For these sites, the
following should be considered.
7.1
Transporting / Storing Supplies
Quality assurance requirements must be maintained wherever kits are stored (e.g.,
temperature monitoring). Kits should not be stored overnight or for extended periods in
unmonitored locations/spaces (e.g., vehicles).
7.2
Testing Space
A flat level surface must be available for testing staff to conduct the test on to avoid spillage
(i.e., flat, level surface such as a carrying case and clipboard). The surface must be able to
be decontaminated with a bleach solution or alternative method of maintaining a clean work
surface that is not capable of transmitting infectious substances.
7.3
Waste Disposal
Mobile sites must have biohazard waste disposal capability (i.e., biohazard waste or sharps
containers).
7.4
Venipuncture Capability
Outreach and mobile sites should either:
a) be equipped and staffed to provide clients with venipuncture to obtain a sample for
standard HIV laboratory testing if the POC HIV result is reactive, indeterminate or
invalid, and/or if the client may have acute or early HIV infection.
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b) establish a procedure to ensure that a venipuncture sample is collected (e.g.,
accompany clients to a nearby laboratory with a completed requisition for HIV
testing).
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SECTION IV: NON-REGULATED AND ALLIED HEALTH CARE PROVIDERS (NRACP)
FRAMEWORK
1.0
PURPOSE
This section is meant to provide additional support for sites involving non-regulated and allied
health care providers (NRACPs) in POC HIV testing. Current evidence supports including
non-regulated and allied health care providers as testers, showing that providers such as
dentists, pharmacists, social workers, licensed practical nurses, counsellors, community
members or “peers”, and community health workers (CHRs - in BC’s First Nations
communities) are appropriate for the tester role. In some cases, NRACP may be more
appropriate for and effective at engaging with people from high prevalence populations or
communities.
Although this Framework is primarily intended for non-regulated care providers, sites with
regulated professionals with limited medical experience or HIV knowledge may wish to use it
as a reference as well. Please refer to the recommendations for Regulated Care Providers.
Regulated health care professionals with medical experience (physicians, nurse practitioners,
nurses) should continue to use the existing Guidelines and are out of scope of this section.
This Framework includes the following consideration and recommendations related to
NRACPs and POC HIV testing:
 Definition of non-regulated care providers and allied health regulated professionals
 Framework components
 Key Management Considerations
 Recommendations for NRACP supervision
Also included are tools to support training and implementation of NRACPs at POC HIV
testing sites:
 Practice Guidance for Regulated Professional and Template for a letter of introduction
for Professional Colleges (Appendix XII and XIII)
 Baseline qualifications for NRACP POC testers (Appendix XIV)
 Key competencies for NRACP POC testers (Appendix XV)
 Training Curriculum Outline (Appendix XVI)
POC Policies and Procedures
This framework is intended to outline considerations and provide recommendations specific
to NRACPs performing POC HIV testing. It does not provide guidelines for POC HIV testing
policies and procedures such as test performance and Quality Assurance (QA). For
additional information on Policies and Procedures for performing POC testing and QA
including provincial standards of practice for POC testing, please refer to sections II and III of
this document.
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1.1
Definitions Non-regulated and Allied Health Care Providers
For the purposes of this framework, other care providers who may potentially perform POC
HIV testing fall into two additional categories:
Regulated allied health care professionals for whom HIV testing does not traditionally lie
within scope of professional practice (e.g., non-physician, non-registered nurse) (This may
include dentists, pharmacists, chiropractors, physiotherapists, massage therapists,
occupational therapists, dietitians, social workers, etc.).
Please see Appendix XII for guidance related to POC HIV testing for regulated health
care professionals.
Non-Regulated Care Providers (NRCPs) who are not regulated by a regulatory body /
College falling under the Health Professions Act (BC Laws 1996).
(This may include community outreach workers, community health workers, peers, care aids
and non-regulated counselors, etc.)
1.2
POC HIV Testing Settings with NRACP
As stated in Section I 9.2, there are no set criteria for determining whether or not POC HIV
testing should be offered in a specific setting. Sites considering the adoption of POC testing
with NRACPs should be determined by Regional Health Authorities and First Nations
communities according to local priorities for expanding and engaging populations in HIV
testing. Factors such as cost/benefit and the infrastructure and resources available to support
this type of expansion should be considered. Sites for NRACP POC testers could potentially
include both community and acute care.
1.3
NRACP Framework Components
SECTION IV: NRACP FRAMEWORK
Provincial & Regional
Laboratories
Non-Profit & Private
Services
First Nations Health
Provincial & Regional
Public Health
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Community & Client-Centered HIV/AIDS Services
This Framework illustrates the basis for best practice in POC HIV testing by NRACP, the
foundation of which is a strong commitment to community and client-centered HIV/AIDS
health services, supported by stakeholders including provincial and regional public health and
laboratories, First Nations Health services, and non-profit and private health services. With
inter-sectorial support and buy-in, POC HIV testing among NRACPs can be realized through
establishing and maintaining the components in the following sections.
2.0
ADVISORY COMMITTEE(S)
A provincial advisory committee, consisting of management and community representatives
involved in HIV testing, developed and approved this NRACP framework, created decisionsupport tools, and gathered information on the successes and challenges of implementation
of POC HIV testing among NRACPs. A provincial HIV POCT Advisory/Accountability
Committee will respond to practice concerns and will continue to create, inform, and revise
policies related to the implementation of this framework, and other issues germane to the
practice of HIV POC testing in the province. The committee consists of at least one key
decision maker from each health authority who will have the authority to regulate POC testing
supplies and designate new POC testing sites in consultation with the Provincial HIV POCT
Program.
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3.0
RESOURCES AND INFRASTRUCTURE
Resources and infrastructure needs related to NRACPs performing POC will depend on
whether or not the setting is already a POC HIV testing site.
For CURRENT HIV POC test sites: changes may need to be made regarding time required to
perform client tests and quality control, and staffing changes to support new policies and
procedures related to training, QC, supervision, and support of NRACP POC testers.
Resources should also include codes of conduct and methods of redress for patients as well
as NRACP POC tester supervision by a qualified medical staff experienced in POC testing.
Testing and Quality Control materials may be self-procured by an organization directly from
the manufacturer, or they may be supplied through the provincial or a regional affiliate
program.
Irrespective of who pays for test kits and Quality Control materials, for all sites, additional
clinical materials (gloves, bandaids, sharps containers, etc) will need to be supplied and may
affect the site’s operational budget. A site lead should be appointed to be in charge of
inventory management, monitoring utilization of test kits, including documentation
requirements (see Section III 5.0).
As outlined in other sections, POC HIV tests should be:
 performed in a confidential setting
 accompanied by pre-test discussion
 include informed consent, post-test counselling and
 enable referral to primary care and supports
Adequate infrastructure must include adequate private consulting spaces and lockable
storage for medical records. Additional resources may be needed to assist community-based
organizations in infection control, safe disposal of medical supplies, to conduct Quality
Control (QC) tests (e.g., a freezer) and to provide follow-up counselling, support, and an
established link to primary care and support services (See Appendix XVII for checklist).
Follow-up testing recommendations are described in Section II 4.0 and include sending a
confirmatory sample to the laboratory. Ideally NRACPs should have the capacity to complete
confirmatory blood testing on site or create a clearly defined pathway to refer clients for a
confirmatory test.
4.0
COMMUNITY READINESS AND MOBILIZATION
Strategies are needed to increase access to and uptake of HIV testing for marginalized
groups, particularly through innovative approaches such as offering POC testing at mobile
clinics, harm reduction programs or outreach. NRACPs may be well-situated in communities
to provide POC HIV testing linked to these services. Inclusion of NRACPs and members of
client populations as testers and in the development of NRACP POC HIV testing program
SECTION IV: NRACP FRAMEWORK
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 43
development, monitoring, and evaluation will help to ensure that the most appropriate and
acceptable practices are followed.
Marginalized communities in the province, especially rural, remote and many First Nations
communities may face additional barriers to implementing POC HIV testing. They require
culturally appropriate and safe supports to engage with the communities and to enable them
to offer HIV POC testing in a manner that ensures confidentiality, increases awareness while
reducing stigma, and connects HIV-positive clients to care available both in and outside of
their communities. Linking to other programs and resources such as Chee Mamuk’s
provincial HIV education programs is an essential step to assessing community readiness
and mobilizing communities to offer and access HIV testing.
Non-regulated care providers such as Community Health Representatives (CHRs) who have
close ties to communities are well placed for providing culturally safe POC HIV testing,
prevention, and linkage to care.
5.0
LINKAGES TO CARE, TREATMENT AND SUPPORT
All HIV POC test providers should have knowledge of local care pathways and community
resources available to individuals who test positive for HIV, as well as prevention services
such as harm reduction supplies and services, for those testing HIV negative. Whenever
possible, clients testing newly positive should be immediately linked to an appropriate HIV
care provider in or near their community. Where possible, a partnership should be developed
with a local clinic for further STI screening and reproductive services as well as support for
new HIV positives.
As part of new site implementation, each site is expected to contact clinics, laboratories, and
the local public health unit to define this support for testers. Testers are expected to follow
these defined linkages to support and care for their clients.
6.0
TRAINING AND COMPETENCIES
As outlined in Section III 2.0, POC HIV tests should be performed by well-trained testers who
can confidently provide and interpret this screen. Records of training, competency and
proficiency assessment should be maintained and be consistent with standards of practice
set forth by professional colleges and/or employers. NRACP training sessions should be
made available through the BCCDC and regional health authorities. See Appendix XVI for
sample modules titled “HIV Testing Education for non-regulated and allied health care
providers.”
There are no specific national or provincial requirements concerning who can perform a HIV
POC test in BC. However, having qualified, trained staff to manage and perform POC tests,
along with QA activities, is one of the most important factors for ensuring accurate and
reliable results. Training for POC HIV testing is outlined in detail in Section III 2.0. Key
aspects include qualifications, training, and competency assessment. See Appendix XIV for
recommended baseline qualifications for NRACP POC testers which include various
attitudes, knowledge, and skills.
SECTION IV: NRACP FRAMEWORK
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 44
Similarly to regulated providers, pre and post HIV test discussion training is a prerequisite to
POC HIV testing training. All NRACP trainings should include completion of a training
program tailored to the NRACPs knowledge level as well as the demonstration of the ability
to perform the POC and quality control tests correctly.
In addition to the POC skills training, NRACPs may require special training and supervision
regarding:
 informed consent and confidentiality
 HIV infection pathology
 care pathways
 healthcare ethics
 stigma and criminalization
 infection control and biosafety
 laboratory procedures
 Transport of Dangerous Goods (TDG)
 health records and documentation
Training can be provided by BCCDC, by the regional health authority or by a combination of
both.
Training is crucial to ensure quality POC HIV testing. NRACP should be fully trained in
performing the tasks and responsibilities associated with POC testing. The key components
to include in training for NRACP POC testers are based on the core competencies outlined in
Appendix XV. Training needs to be ongoing and linked to performance monitoring. Trained
testers should be able to competently demonstrate use of the POC test kit and QC materials.
Continuing education and ensuring ongoing competency for testers and activity examples are
outlined in Section III 2.2. These activities are determined by the employers and can be done
using a variety of methods. Assessments may be thorough without being complicated or
time-intensive.
7.0
KEY MANAGEMENT CONSIDERATIONS
When assessing the expansion or introduction of NRACP HIV POC testers, management /
employer of the organization should be guided by expectations of these guidelines, and the
following considerations:
 Who would be your local or regional medical contact for providing practice support to
your NRACP POC testers (i.e. a physician, NP or RN)?
 Have you connected with the Provincial HIV POC Program to request inclusion in the
provincial program for supplies? Has your request been authorized by your health
authority liaison who will be accountable for your program? (Contact the Provincial
HIV POC Program for more information.)
 Is your organization linked to your regional public health services and are there
mechanisms for reporting HIV POC screening results and connecting clients for public
health follow-up should they be HIV-positive?
 What program tools are available to support NRACPs in their work with clients?
SECTION IV: NRACP FRAMEWORK
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 45







What professionals or partner organizations can the NRACP liaise with in order to get
a confirmatory blood sample drawn on-site or a lab test ordered (e.g. physician, nurse
practitioner, registered nurse, phlebotomist) should it be needed?
What trainings (including pre-post HIV test discussion and HIV POC training) are
available in your region and how would you support your staff to be trained and to
receive ongoing support and assessment?
What kind of accountability mechanism exists in your organization for unregulated
care providers in the absence of professional regulatory bodies that govern health
care professionals?
Does the professional regulatory body of allied health regulated professionals (SW,
pharmacists, etc.) support the practice of HIV POC testing? This may require special
approval from their registrar for a pilot. (See appendix)
Does your organization have a department of professional practice that supports this
initiative?
Does your organization have insurance for the testers in the event of any liability
issues arising for POC HIV testing with NRACPs? Do you require any additional
insurance?
If testers are volunteers rather than employees within an organization, do they have
insurance coverage under the employer or another source?
This framework recommends that POC HIV testing be assigned by the Health Authority /
employer to a regulated or non-regulated care provider by outlining it as a task that is within
the role description and training of the tester as defined by the employer / supervisor and is
integrated into their formal job description where possible.
If registered health professionals such as physicians, nurse practitioners or registered nurses
are present in the healthcare setting, it is recommended that employers develop formal
processes to share responsibility for quality of care between these professionals and other
care providers. An employer may choose to request that these professionals delegate or
assign POC HIV testing whereby the physician or registered nurse/ NP maintains primary
responsibility for the POC testing as a task. Please note that it is outside an LPN’s practice to
designate such tasks.
Please refer to Professional Standards and Guidelines for Delegation of Medical Acts
according to the College of Physicians and Surgeons of British Columbia and the College of
Registered Nurses of British Columbia’s Practice Support; Assigning and Delegating to NonRegulated Care Providers. For LPN practice please refer to the College of Licensed Practical
Nurses website for LPN scope of practice information (contact information is in the Reference
Section).
8.0
ACCOUNTABILITY AND SUPERVISION OF NRACPs
To be included in the provincial POC program each health authority must designate a
physician or nurse leader (e.g., MHO, Practice Lead for a Health Authority) as a liaison for
POC testing to join the advisory council and authorize new sites in their region in consultation
with the provincial HIV POC Program. This Health Authority person/team may provide
practice support and opportunities for continuing education and assessment of NRACP POC
SECTION IV: NRACP FRAMEWORK
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 46
testers in the community. Although organizations (e.g., Health Authority, NGO, etc) have
legal and ethical responsibility for their employees who provide POC HIV testing as a part of
their job, regional supports are crucial to maintaining clinical confidence and competence of
testers.
SECTION IV: NRACP FRAMEWORK
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 47
REFERENCES
Accreditation Canada Point of Care Testing Standards March 1, 2012
BCCDC. BCCDC HIV Testing Training Videos. 2012. Available at:
http://phsa.mediasite.com/mediasite/Catalog/Full/ae4cef7b1abf40a2aa647137536c00c121
BCCDC. Starting POC at Your Site. Available at:
http://www.bccdc.ca/SexualHealth/Programs/ProvincialPointofCareHIVTestingProgram/Starti
ngPOCHIVTest.htm
BCCDC. Point of Care Site Resources. Available at:
http://www.bccdc.ca/SexualHealth/Programs/ProvincialPointofCareHIVTestingProgram/POC
SiteResources.htm#ProgTemp
BioLytical.com website. (Accessed March, 2014). Available at: www.biolytical.com
BC Laws. Health Professions Act. 1996. (Accessed March 2014).Available at:
http://www.bclaws.ca/Recon/document/ID/freeside/00_96183_01
BC Office of the Provincial Public Health Officer. HIV Testing Guidelines for the Province of
British Columbia. May 2014.
British Columbia HIV Prevalence and Incidence Estimates used to Construct the 2008
National HIV Estimates: Updated December 7, 2009. Surveillance and Risk Assessment
Division, Centre for Infectious Disease Prevention and Control (CIDPC), Public Health
Agency of Canada.
Burdge DR, Money DM, Forbes JC, Walmsley SL, Smaill FM, Boucher M, et al. Canadian
consensus guidelines for the management of pregnant HIV-positive women and their
offspring. Canadian Medical Association Journal (online), 1-14. 24-6-2003.
Canadian Aboriginal AIDS Network (2012). Assessing community readiness and
implementing risk reduction strategies. Available at: http://caan.ca/wpcontent/uploads/2012/05/CR-manual-eng.pdf
Chansonneuve, D. (2007). Reclaiming Connections: Understanding Residential School
Trauma among Aboriginal People. Ottawa, ON: Aboriginal Healing Foundation
CLSI. A Quality System Model for Health Care; Approved Guideline. CLSI document HS01A2 Clinical Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne,
Pennsylvania 19087-1898 USA, 2002.
CLSI. Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual
and Resources for Health Care Workers; Approved Guideline. CLSI document POCT08-A.
Wayne, PA: Clinical and Laboratory Standards Institute; 2010.
College of Licensed Practical Nurses of British Columbia. Scope of Practice for Licensed
Practical Nurses: Standards, Limits and Conditions. (Accessed April 2014) Available at:
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https://www.clpnbc.org/Documents/Practice-Support-Documents/Scope-of-PracticeONLINE.aspx
College of Physicians and Surgeons of British Columbia. Delegation of a Medical Act.
Professional Standards and Guidelines. (Accessed April 2014) Available at:
https://www.cpsbc.ca/files/pdf/PSG-Delegation-of-a-Medical-Act.pdf
College of Registered Nurses of British Columbia’s. Practice Support; Assigning and
Delegating to Non-Regulated Care Providers. (Accessed April 2014) Available at:
https://www.crnbc.ca/Standards/Lists/StandardResources/98AssigningDelegatingUCPs.pdf
Cook D, Gilbert M, DiFrancesco L, Krajden M. Detection of early sero-conversion HIV
infection using the INSTI™ HIV-1 Antibody Point of Care Test. The Open AIDS Journal,
2010; 4:176-179.
Expert Working Group on Canadian Guidelines for Sexually Transmitted Infections. Canadian
Guidelines on Sexually Transmitted Infections 2006 Edition. Public Health Agency of Canada
2006.
Gilbert M. Impact and use of point of care HIV testing: a public health evidence paper. BC
Centre for Disease Control; 2010. Available at: www.bccdc.ca under "Statistics and Reports".
Hadland, S.E., Marshall, B.D.L., Kerr, T., Qi, J., Montaner, J.S., Wood, E. (2011). Suicide and
history of childhood trauma among street youth. Journal of Affective Disorders, 136(2012),
377-380.
Harris, M., & Fallot, R., D. (2001). Using Trauma Theory to Design Service Systems. San
Francisco, CA: Jossey Bass
Health Professions Act, Government of British Columbia, 2007.
Hopper, E.K., Bassuk, E.L., Olivet, J. (2010). Shelter from the storm: Trauma-informed care
in homelessness services settings. The Open Health Services and Policy Journal, 3, 80-100.
INSTI™ test kit Manufacturer’s insert. INSTI™ HIV-1/HIV-2 Antibody test kit. bioLytical
Laboratories Inc. Richmond B.C. 50-1028I. ©2012.
INSTI™ HIV-1 Test controls. bioLytical Laboratories Inc. Richmond B.C. Product # 80-1037.
50-1045N. ©2013.
Pearce, M.E., Christian, W.M., Patterson, K., Norris, K., Moniruzzaman, A., Craib, K.J.P., et
al. (2008). The Cedar Project: Historical trauma, sexual abuse and HIV risk among young
Aboriginal people who use injection and non-injection drugs in two Canadian cities. Social
Science & Medicine, 66, 2185–2194
Peer Testing Project (VCH). Available at: http://www.catie.ca/en/pc/program/peer-testingproject. 2011
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May 2014
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PHSA Laboratories, Central Processing and Receiving Laboratory. Mel Krajden. Unpublished
data. 2014.
PHSA Laboratories Guide to Programs and Services, BCCDC Public Health Microbiology &
Reference Laboratory. April 2014. Available at: http://www.phsa.ca/NR/rdonlyres/D632D3568E8F-4917-BC3D-463EB5F8A14B/0/GuidetoProgramServices.pdf
PHS Community Services Society. Peer HIV Testing. CATIE. Available at:
http://www.catie.ca/en/pc/program/peer-testing-project
PHSA Laboratories, Quality Manual. Vancouver, B.C. Version 2.00. February 2014.
Plested BA, Jumper-Thurman P, Edwards RW. Community Readiness Manual and
Community Readiness Toolkit. 2009. Available at: http://www.nccr.colostate.edu/order.html
Policies, Procedure and Quality Assurance for Point of Care HIV Testing in Ontario. Ontario
Ministry of Health, Aids Bureau. Sept 2008.
Public Health Agency of Canada (2013). Human immunodeficiency virus HIV Screening and
Testing Guide. Available at: http://www.phac-aspc.gc.ca/aids-sida/guide/hivstg-vihgddeng.php#a
WHO Curriculum – Rapid HIV Tests: Guidelines for use in HIV testing and counselling
services in resource-constrained settings, 2004. Available at:
http://applications.emro.who.int/aiecf/web28.pdf
WHO HIV Rapid Test Training Curriculum. 2010. Available at:
http://www.who.int/diagnostics_laboratory/documents/guidance/hivrttraining_overview/en/
REFERENCES
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 50
APPENDICES
Many of the following Appendix documents are available on the Provincial Program webpage
as PDF or customizable documents. Please download from the webpage rather than using
versions found in the Guidelines.
Link to Provincial Program webpage:
http://www.bccdc.ca/SexualHealth/Programs/ProvincialPointofCareHIVTestingProgram/POC
SiteResources.htm#ProgTemp
Appendix documents applicable to all readers include:
Appendix I to Appendix XI
Appendix documents specific for Non-regulated or Allied Health Care Providers:
Appendix XII to Appendix XVII
APPENDICES
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 51
APPENDIX I — Summary of Test Properties
INSTI™ HIV-1 / HIV-2 Antibody Test Kit
Supplier: bioLytical Laboratories Inc.
License Issue Date (Class IV Medical Device): October 25, 2005
COMPONENTS:
INSTI membrane unit contains HIV-1 (gp41) and HIV-2 (gp36) recombinant proteins
(which capture HIV-1 and HIV-2 specific antibodies), and a procedural control (protein-A
treated spot) which detects the presence of IgG antibodies normally present in blood
and blood components
SAMPLE TYPE:
Fingerstick blood, EDTA-treated whole blood or plasma, serum.
VALIDATION FOR USE:
Validated for HIV-1, HIV-2 antibodies.
Not validated for detection of antibodies to HIV-1 N subtype.
TEST PERFORMANCE:
Fingerstick whole blood ♥ :
Sensitivity
Specificity
Sensitivity 99.6% [95% CI 98.9-99.9%],
Specificity 99.7% [95% CI 99.4-99.8%]
Positive
Fingerstick whole blood: PPV varies according to HIV prevalence.
Predictive
HIV Prevalence
PPV
Value (PPV)
0.1%
(1 in 1000)
12.5%
0.2%
(1 in 500)
22.2%
1.0%
(1 in 100)
58.9%
10.0%
(1 in 10)
94.0%
Low Antibody Performance equivalent to standard HIV testing protocols using
Titer
commercial low titer performance panels.
Window
When compared to standard HIV testing on 25 established commercial
period
seroconversion panels the INSTI™ HIV Test was reactive: at the same
time (14/25, 56%) or up to eight days later than standard testing (9/25,
36%). In the remaining two panels (8%), the INSTI™ HIV Test was not
reactive by the last bleed in the seroconversion panel.
The sensitivity of the INSTI™ HIV Test for detection of acute HIV
infection is 69.4% [95% CI 54.6%-81.8%].
PRECAUTIONS:
False negative or invalid test results may be obtained in clients with severe
hypogammaglobulinemia conditions (e.g., multiple myeloma), patients receiving
HAART, and patients with elevated hemoglobin.
STORAGE:
Storage temperature 15-30 °C, shelf-life 12 months.
EXTERNAL QUALITY CONTROL:
In place (August 2007)
♥ See product insert for sensitivity and specificity using other sample types.
APPENDICES
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 52
APPENDIX II — Roles and Responsibilities
This document summarizes the roles and responsibilities of the Tester, the Health Authority/Site, the BCCDC Provincial POC Program and service
providers such as bioLytical and the proficiency testing service provider. Collaboration of all of these groups is critical to the success of a POC HIV testing
program. The BCCDC Provincial Point of Care Testing program has created the Point of Care Guidelines for Health Care Settings; sites/Health Authorities
are responsible for adapting and implementing these guidelines to meet their specific needs and operational policies/procedures.
Activity
Tester
(approved by site and/or Health
Authority)
Testing
Process







APPENDICES
Provide pre and post discussions,
including informed consent, to clients
according to established process and
procedures.
Perform client testing and interpret
results according to established
procedures.
Deliver test results to client according
to established procedures.
Obtain venous blood sample for
confirmatory testing as applicable and
arrange for follow up with client
regarding confirmatory test results.
Record usage and results of each test
kit on client testing log used at site
(including those used for quality
controls, wasted, training etc.)
Follow site policies regarding
confidentiality of records.
Report concerns/problems with the test
kit performance to POC site lead and
provincial program manager as
applicable.
Site /Health
Authority*
Provincial Program
These items may be the
responsibility of the Health
Authority or site and is to be
determined at a regional level.





Allocate sufficient clinic,
material and human
resources to implement,
operate, review and
maintain the use of POC
HIV testing within each site.
Ensure necessary
equipment available for
testing (i.e. gloves, sharps
containers, Band-Aids).
Report all reactive results to
Medical Health Officer
according to established
regional procedures for
communicable disease
reporting.
Collaborate with testers to
ensure appropriate
implementation of POC HIV
testing.
Report concerns/problems
with the test kit performance
to provincial POC HIV
Service Provider:
bioLytical
(manufacturer of INSTI test kit)






Prepare, maintain and report

budget status and requirements
to the appropriate committees

and management teams.
Provide monthly summaries of
POC test kit usage by Health
Authority and provincially to the
appropriate committees and
management teams.
Provide data regarding test kit
usage to Health Authority/Site as
requested.
Provide support to sites
performing POC HIV testing
including training, procurement,
distribution and trouble shooting.
Follow up with sites on abnormal
results (i.e. invalid, indeterminate,
false negative, false positive).
Report concerns/problems with
the test kit performance to
appropriate BCCDC managers
and to bioLytical.
Provide advice regarding usage
and specifications of test kit.
Follow up on concerns/problems
related to test kit performance
and provide direction on the use
of kits.
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 53
Activity
Tester
(approved by site and/or Health
Authority)

Participate in the evaluation of the
POC HIV testing program.
Site /Health
Authority*
Provincial Program
These items may be the
responsibility of the Health
Authority or site and is to be
determined at a regional level.

testing program manager.
Participate in the evaluation
of the POC HIV testing
program.
(manufacturer of INSTI test kit)



APPENDICES
Service Provider:
bioLytical
Collaborate with testers, Health
Authority/site to ensure optimal
implementation of POC HIV
testing at site, health authority
and provincial levels.
Disseminate product information
and feedback to Health
Authorities/Sites if concerns have
been raised and subsequently
addressed by bioLytical.
Evaluate the POC HIV testing
program and report findings from
the evaluation to the appropriate
committees and management
teams.
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 54
Activity
Tester
Site /Health
Authority*
(approved by site and/or Health
Authority)

Training
 Competency
 Continuing

education/
refresher
training


Participate in POC as well as HIV pre
and post test discussion training
programs.
Successfully complete competency
assessment before testing clients in
collaboration with POC site lead.
Participate in periodic refresher
training and continuing education.
Participate in additional training as
identified during Site Approval
Process.
These items may be the
responsibility of the Health
Authority or site and is to be
determined at a regional level.






APPENDICES
Provincial Program
Schedule staff training in
collaboration with provincial
program.
Verify that trained staff
members have successfully
completed competency
assessment before testing
clients.
Retain training and
competency records for all
staff (tracked, filed and
retained for 10 years).
Schedule periodic refresher
training and continuing
education for testers.
Identify additional non-HIV
training requirements.
Verify new testers have
completed all HIV and nonHIV training/competency
requirements.
Service Provider:
bioLytical
(manufacturer of INSTI test kit)




Develop training materials such
as presentations, checklists etc.
Coordinate, participate and
deliver content for training as
requested by and in collaboration
with Health Authorities/sites.
Develop continuing education
materials and coordinate
continuing education sessions in
collaboration with Health
Authority/Site as needed.
Cooperate with appropriate
trainers in the development and
presentation of associated nonHIV training materials.
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 55
Activity
Tester
(approved by site and/or Health
Authority)
Quality
Control
Samples




Store and use quality control samples
according to manufacturer’s
instructions.
Use quality control samples as per
provincial program guidelines.
Record quality control sample results
and notify POC site lead of any
unexpected results.
Contact POC site lead/provincial
program manager if quality control
samples fail to give the result
expected.
Site /Health
Authority*
These items may be the
responsibility of the Health
Authority or site and is to be
determined at a regional level.





APPENDICES
Provincial Program
Order quality control
samples through the
provincial POC HIV testing
program.
Assume responsibility for
integrity of quality control
samples in health
authority/site.
Ensure quality control
samples are stored as per
manufacturer’s instructions
and contact provincial POC
HIV Testing Program if
there is a concern with
storage.
Review POC HIV test kit
usage log sheets and take
corrective action as
required.
Contact provincial POC HIV
testing program in the event
of a problem with quality
control samples.
Service Provider:
bioLytical
(manufacturer of INSTI quality
control samples)




Purchase quality control samples 
for sites.
Provide guidance around the use 
of quality control samples and
training.
Act as a resource for quality
control sample
problems/concerns.
Contact the manufacturer as
needed.
Manufacture and ship quality
control samples.
Respond to any issues related
to quality control samples.
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 56
Activity
Tester
Site /Health
Authority*
(approved by site and/or Health Authority)
Provincial Program
These items may be the
responsibility of the Health
Authority or site and is to be
determined at a regional level.
Inventory



Track test kit usage on daily log of client 
POC test results, and Quality Control
Log.
Report when kit inventory is low or

close to expiration date to POC site
lead.
Store test kits and materials as
indicated in provincial guidelines.



Evaluate testing site needs
for each upcoming order
cycle.
Collaborate with provincial
POC HIV Testing Program
to order test kits and
required supply inventory.
Assume responsibility for
test kits at site/in health
authority.
Forward testing Monthly
Summary Report (see
Appendix IX) to provincial
POC HIV testing program.
Participate in kit
redistribution to optimize
utilization and eliminate
wastage in such instances
as kits being near expiration
date.
(manufacturer of INSTI test kit)









APPENDICES
Service Provider:
bioLytical
Initiate renewal of contract with
kit vendor.
Order test kits on behalf of sites
and organize distribution and
delivery.
Verify Certificate of Analysis for
each lot number received.
Retain the original Certificate of
Analysis for each kit lot number
and provide a copy to testing
sites on request.
Verify performance of new lot.
Verify ongoing performance of
each lot.
Order and distribute supplies
such as quality controls, extra
lancets, pipets and temperature
monitors.
Disseminate information
regarding inventory changes to
sites in a timely manner.
Coordinate redistribution of
limited date kits in collaboration
with Health Authorities/sites to
enhance utilization.



Inform the POC HIV Program of
any product updates or changes
related to test kits, quality
controls samples or other
associated testing materials in a
timely manner.
Supply test kits and quality
control samples with the
maximum expiry date possible.
Provide the Certificate of
Analysis for each kit lot with
each shipment
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
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Page 57
Activity
Tester
(approved by site and/or Health
Authority)
Storage of
INSTI Test Kits



Documentation 
and Reference
Material


APPENDICES
Site /Health
Authority*
Provincial Program
These items may be the
responsibility of the Health
Authority or site and is to be
determined at a regional level.
Service Provider:
bioLytical
(manufacturer of INSTI test kit)
Complete daily temperature logs for 
all areas where test kits are stored,
and notify POC site lead of any
temperature outside the accepted
range.
Move stock as needed if temperature 
goes out of range.
Run QC to ensure kits are
acceptable for client use if
temperature ranges are exceeded.
Ensure temperature logs are
maintained regularly for all
areas where test kits are
stored and take corrective
action as required.
Assume responsibility for
storage of test kit materials
and supplies.

Provide sites with temperature
monitors as needed or
recalibrate existing monitors as
scheduled.
Complete and retain all

documentation as outlined in the
provincial program guidelines, and/or 
per site/HA requirements.
Use most recent version of provincial 
program guidelines and
manufacturer’s instructions.
Provide feedback to provincial
program on suggestions for new
documents, or revisions of current
documents.
Maintain all documentation
as required.
Review Client and QC logs
at least monthly
Ensure the most recent
version of provincial program
guidelines and
manufacturer’s instructions
are being used by testers.

Liaise with testers and Health
Authority/Site supervisors to
update documents and
reference materials as required.

Notify provincial program
regarding changes to product
documents.
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Activity
Tester
Site /Health
Authority*
(approved by site and/or Health
Authority)
Risk
Management

Report abnormal/unexpected
errors/outcomes to the POC site
lead.
These items may be the
responsibility of the Health
Authority or site and is to be
determined at a regional level.



Recall Process




APPENDICES
Respond to recall alert messages
from Provincial Program.
Review current stock for recalled
product.
Quarantine recalled product and
follow instructions from Site Lead and
contact Provincial Program Manager
regarding outcomes.
Re-test clients as recommended by
Provincial Program Manager.
Provincial Program




Service Provider:
bioLytical
(manufacturer of INSTI test kit)
Retain and store clients log
sheets in case of need to
communicate problem with
test kit to clients.
Investigate unexpected
outcomes, record actions
and ensure implementation
of corrective actions.
Report
abnormal/unexpected
results to the provincial POC
HIV testing program.

Ensure recalled product has
been identified and
quarantined for all sites
Communicate with sites,
Provincial Program and
bioLytical throughout entire
process.
Lead process for client
retesting as necessary.
Retain all documents related
to the recall event





Discuss abnormal/unexpected

results with Health Authority/site
supervisors.
Report to advisory and steering
committees as required.
Relay information on changes
or problems with test kits to all
sites as applicable.
Report abnormal/unexpected
results to appropriate BCCDC
management and to bioLytical
as applicable.
Facilitate communication
between POC Site Leads/sites
and bioLytical.
Determine if client retest is
needed and facilitate process
as needed



Respond to any concerns
regarding kit performance and
provides guidance as to how to
proceed.
Initiate recall process.
Liaise with Provincial Program
Manager throughout the recall
process.
Provide clear instructions of
expectations to Provincial
Program and sites.
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Activity
Proficiency
Testing
Tester
Site /Health Authority*
(approved by site
and/or Health
Authority)
These items may be the
responsibility of the Health
Authority or site and is to be
determined at a regional level.

Participate in
proficiency
testing as
requested.




Work with provincial program
to enroll sites in proficiency
testing program.
Schedule staff participation in
proficiency testing events.
Review proficiency testing
results with staff, and follow up
concerns accordingly.
Maintain proficiency testing
records.
Provincial Program
Service
Provider:
bioLytical
(manufacturer of
INSTI test kit)




APPENDICES
Service Provider:
Proficiency Testing
provider
Initiate and manage
contract with proficiency
testing provider on behalf
of the sites.
Act as the contact for
sites if concerns or
questions arise.
Analyze provincial
proficiency testing data
results in aggregate form
and report on results as
part of the Provincial POC
HIV Testing program
evaluation.
Offer support/assistance
(i.e. training) for those
sites that discover errors
as a result of their
participation in the
proficiency testing
program.




Manufacture and distribute
the proficiency testing
materials to sites.
Respond to issues regarding
shipments or testing
schedule.
Analyze data from all
participating sites.
Create and distribute reports
to participating sites.

Respond to any
proficiency testing
issues related to kit
performance.
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APPENDIX III — Daily Log of Client POC Test Results
Testing site:
________________________________ POC Test Lot Number (on Box): ______________________
Reviewer’s signature: ________________________________ Expiry Date (on Box):
______________________
Date of
Test
Tester
Initials
dd/mm/yyyy
Client Identifier 1*
(ie Name, Chart
Number, DOB)
Client
Identifier
2*
POC Test
Result
Reactive
Non-reactive
Invalid
Indeterminate
HIV
Serology
Collected
or
Requested
(Yes, No)
HIV Serology
Result
Reactive
Non-reactive
Indeterminate
Not Done
Reactive POC
Test Final
Result
TP – True Pos
FP – False Pos
Notes /
Comments
(# of test kits
left)
PP – Prelim Pos^
* A minimum of two client identifiers is recommended for accuracy of client information. Where electronic client records are used, the chart number can be used here if
two identifiers are in the client record.
^ In this context, Preliminary Positive refers to individuals having a reactive POC test result but are lost to follow-up and confirmatory serology was not performed.
APPENDICES
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APPENDIX IV — Fax Template Form
APPENDICES
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APPENDIX V — Direct Observation Checklist for POC HIV Testing
Test Provider: ________________
Observer: ________________
Did the test provider:
1.
Check to ensure Quality Control has been performed according to
requirements prior to testing the client sample?
2.
Obtain informed consent for the test?
3.
Offer standard laboratory HIV testing or POC testing to the client?
4.
Record the client and test information on the testing log sheet?
5.
Record or check the lot number and expiry date of the test kit?
6.
Provide a clean area on which to perform testing?
7.
Wash/sanitize hands prior to starting the testing process?
8.
Remove the membrane from the pouch without touching the centre
well?
9.
Wear gloves to perform the test?
10. Wipe client’s selected finger thoroughly with alcohol swab prior to
puncture?
11. Dispose of the used lancet directly into a sharps container?
12.
Fill the pipette to the fill line to obtain the required amount of blood?
13. Transfer the blood in the pipette into the solution 1 vial by squeezing
the bulb of the pipette to dispense the blood into the vial?
14. Dispose of the used pipette directly into a biohazard waste
container?
15. Mix the blood in solution 1 vial by gentle inversion?
16.
Test the sample within 5 minutes of mixing blood with solution 1?
17. Mix solution 2 by gently turning it upside down and ensuring
contents mixed?
18. Add the entire contents of solution 2 to the centre of the membrane
unit and allow time to absorb?
19.
Add the entire contents of solution 3 to the centre of the membrane
unit and allow time to absorb?
APPENDICES
YES
NO
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Did the test provider:
YES
NO
20. Read the result within 5 minutes of adding the clarifying solution
(solution 3)?
21. Remove and dispose of gloves into biohazard waste container?
22. Record the result on the testing log sheet?
23. Discuss and advise testing for HIV using venous blood collection for
clients who tested negative with POC test but may be in the window
period?
24. Draw venous blood when POC test was reactive, invalid (a second
time), indeterminate or if an acute HIV infection is suspected?
25.
Label the venous blood in the presence of the client with all required
identifiers?
26. Complete the laboratory requisition as required?
27. Provide client an opportunity to express degree of satisfaction with
the testing process (via web link card or printed survey)?
Number of test kits used under observation:
_________
Observer: _____________________________
Date: _________________
Follow-up issues identified?
YES _____
NO ______
Comments:
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
Review of direct observation by trainer/assessor
The test provider has demonstrated competence
YES _____
NO ______
Observer: _____________________________
Date: _________________
Note that it is recommended that POC HIV Testing competencies are reviewed once per year.
APPENDICES
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APPENDIX VI — Training Completion Requirements for Nurses, Physicians, NursePractitioners
The following completion requirements specifically pertain to the use of the POC HIV test. It is
expected that learners attending POC training have knowledge of the following prerequisites:

HIV Pre- and Post-Test discussions

Legal and professional requirements and practice standards for obtaining informed
consent

Legal and professional requirements and practice standards for maintaining
confidentiality
To successfully complete the POC HIV testing training, the learner must attend a two- to threehour POC testing workshop and at completion of the training workshop independently
demonstrate at minimum the following competencies:
POC HIV Testing
Initial Testing and Quality Assurance Training — Competencies
Trainer
Initials
1. Demonstrate the appropriate use and interpretation of the POC HIV test.
2. Demonstrate the procedures for using quality control samples.
3. Demonstrate a client-centered approach when obtaining informed consent, for
maintaining confidentiality, and when providing client education.
4. Demonstrate a client-centered approach when interpreting and providing the
POC test result and when discussing next steps and follow-up.
5. Demonstrate how and when to report POC test results.
6. Describe potential errors and measures to reduce errors related to use of the
POC test kit and quality control materials.
7. Describe follow-up and referral process for confirmed HIV positive standard lab
tests.
By signing below, the learner and trainer are declaring that the learner has competently, ethically,
and safely demonstrated the above completion requirements. It is recommended that POC HIV
Testing competencies are reviewed once per year.
Learner Name:
Learner Signature:
Trainer Name:
Trainer Signature:
Date:
Completed form to be retained by the POC Site Lead.
APPENDICES
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APPENDIX VII — Training Competencies for Nurses, Physicians, Nurse-Practitioners
Core POC HIV Test Provider Competencies
Knowledge of:
 legislation,
confidentiality, and
informed consent
related to HIV
testing
 HIV infection and
window period and
the impact on
testing
 HIV diagnostic
tests and
appropriate use
 how to implement
and sustain quality
assurance
activities
 education and
communication
techniques
 documentation
and reporting
requirements
Skill in:
 obtaining informed
consent
 describing the
diagnostic test
options available
 using POC test kit
and running
quality controls
 collecting POC
test sample
 interpreting test
results and
providing
appropriate followup and
determining next
steps based on
results
 collecting or
referral for
collection of
venous sample
 providing
appropriate client
education
 collecting and
documenting
data for
surveillance,
reporting, and
case
management
APPENDICES
Judgment regarding:
 choosing the
appropriate HIV
diagnostic product
(i.e. standard or
POC testing)
 client follow-up and
referral based on
HIV test results
 referring clients to
appropriate
services (i.e.
treatment,
counseling)
Attitude that:
 respects client’s
choices and
beliefs
 demonstrates
self awareness
of own beliefs,
values, and
practice
limitations
 demonstrates
sensitivity
regarding
impact of HIV
diagnosis,
reporting, and
partner
notification
 respects and
supports the
adherence to
quality
assurance
activities
Communicable Disease Control Manual – Chapter 5
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APPENDIX VIII — Quality Control Log
Testing site: ______________________________
Date of
Quality
Control
Tester
Initials
dd/mm/yyyy
1.
3.
5.
7.
Quality Control
Material
Quality Control Lot
Number
POC Test Lot
Number
(Negative,
Positive HIV-1
Positive HIV-2)
(On Vial)
(On Box)
Receive new shipment
New tester, before they start testing
Change to new lot number
Temperature out of range (below 15C or above 30C)
APPENDICES
POC Test Result
Reactive
Non-reactive
Invalid
POC Test
performs as
expected
(Yes, No)
Notes / Comments
Reason for testing
(from numbers
below)
2. Invalid client result X 2
4. At regular intervals - monthly
6. Trouble-shooting
Site Lead
Review
Initial
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APPENDIX IX — Monthly Summary Report
APPENDICES
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APPENDIX X — Incident Summary Form
APPENDICES
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APPENDIX XI — Temperature Monitoring Log
Room Temperature Log for INSTI Kit Storage
Site:
Day
Month:
Notify POC Site Lead when temperature is:
less than 15 0 C more than 30 0 C
Time
# Kits
hh:mm
Monitor Record
Temp
Acceptable?
0
C
Minimum Maximum Yes/No
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Reviewed by:
Comments:
APPENDICES
Review Date:
Initials
Year:
Not Acceptable?
Actions
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APPENDIX XII — Practice Guidance for Allied Health – Regulated Health Care
Providers
Regulated health care providers interested in including Point of Care HIV testing in their
professionals practice are recommended to follow these steps prior to initiating training and
beginning POC testing:
 Contact your professional college to find out if Point of Care testing has already been
approved as part of your scope of practice.
 If your professional college is unfamiliar with Point of Care HIV testing or unclear
about whether or not it could be part of your scope of practice, refer them to the letter
of introduction of the BCCDC below and contact the provincial POC HIV testing
program (BCCDC) for additional informational and supportive resources to provide to
your professional college.
 Once POC HIV testing has been approved as part of your scope of practice, begin the
steps to implementing it within your practice and health care setting.
Definition of Allied Health: provide diagnostic, therapeutic, and rehabilitative health
services. These fields encompass all professions in health care with the exception of
Medicine and Nursing and may or may not be regulated. The Canadian Association of Allied
Health Programs (www.caahp.ca) recognizes the following allied health programs:

Anaesthesia Technology, Biomedical Engineering Technology , Cardiac Sciences,
Dental Sciences, Electro-neurosciences , Emergency/ Paramedic, Environmental
Health, Food & Nutrition, Health Information Sciences, Medical Imaging Sciences,
Medical Laboratory Sciences, Ophthalmic Sciences, Pharmaceutic Sciences,
Radiation Therapy, Rehabilitation Sciences, Respiratory Therapy, Traditional Chinese
Medicine
Definition of regulated health care provider: There are 26 regulated health professions in
British Columbia, of which 25 are self-regulating professions governed by 22 regulatory
colleges under the Health Professions Act. Social workers are a self-regulating profession
governed by a regulatory college under the Social Workers Act. A list of regulated
professionals is available here:
http://www.health.gov.bc.ca/professional-regulation/index.html#redirect_notice_display_301

Chiropractic, Dental Hygiene , Dental Technology, Dentistry, Denturism, Dietetics,
Emergency Medical Assisting, Massage Therapy, Medicine, Midwifery, Naturopathic
Medicine, Nursing (Licensed Practical), Nursing (Registered), Nursing (Registered
Psychiatric), Occupational Therapy, Opticianry, Optometry, Pharmacy, Physical
Therapy, Podiatric Medicine, Psychology, Speech and Hearing Health Professions,
Traditional Chinese Medicine and Acupuncture, Social Work
APPENDICES
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APPENDIX XIII — Sample Letter for Colleges
Dear Colleagues,
This letter is meant to provide Professional Colleges in BC with information to introduce and
assist College Staff in decision-making regarding Point of Care (POC) HIV Testing’s inclusion
in scope of their professional practice.
HIV testing has traditionally been done through venous blood draws and therefore has been
performed primarily by medical staff including physicians, nurses, and medical laboratory
technicians. It follows then that these professionals were the first in BC to implement POC
HIV testing as part of their practices. However, given the simplicity of the finger poke
screening procedure of HIV Point of Care Testing, diverse groups of professionals and
community workers are capable of performing and interpreting this POC HIV screening test.
POC HIV testing is widespread and performed by various groups of regulated and nonregulated providers throughout Canada and globally. Point of Care HIV Testing is relatively
new as a practice in BC with the introduction of BC’s Provincial HIV Point of Care HIV
Testing Program in 2011. Several professional Colleges that fall under the BC Professions
Act have begun or completed the process of review and inclusion of POC HIV testing into
their professional practice.
The Provincial Point of Care HIV Testing Background
Please refer to the BCCDC’s website and POC page for further information and to link
to the Point of Care HIV Test Guidelines for Health Care Settings at www.bccdc.ca/POC.
Point of Care (POC) HIV tests (also known as “rapid” HIV tests) are HIV antibody screening
tests which can be performed on-site while the client waits, and provide results within
minutes. In August 2010, the BC Centre for Disease Control (BCCDC) was asked by the
Ministry of Health to introduce a Provincial POC HIV Testing Program to oversee centralized,
province-wide HIV point of care testing, distribution, and quality assurance program funded
through the provincial pilot project, Seek and Treat for the Optimal Prevention of HIV/AIDS
(STOP HIV/AIDS). As a result, POC HIV testing has been used in all Health Authorities in
British Columbia. The BCCDC has published provincial practice guidelines: Point of Care HIV
Test Guidelines for Health Care Settings. The INSTI HIV-1/HIV-2 Rapid Antibody Test is the
only POC HIV test product licensed for use in health care settings. Please refer to the
manufacturer’s website for further product and quality information at
http://www.biolyticalcanada.com/
Recommended Testing Sites:
POC HIV Testing is recommended for use in voluntary HIV testing settings accessed by a)
high prevalence populations b) where not returning for test results is common, or c) where
provision of a POC HIV test result will improve public health follow-up or connection to HIV
clinical care. It is also recommended in clinical scenarios where there is an urgent need to
determine HIV status (i.e. pregnant women near-term or in labour with undocumented HIV
status, testing of source individual during blood and fluid exposures, or clinical diagnosis of
acutely ill patients).
Roles and Responsibilities:
APPENDICES
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Shared roles and responsibilities between Health Authorities, First Nations health agencies
and BCCDC facilitate the appropriate use of POC HIV testing in communities by designating
appropriate healthcare sites for offering POC HIV testing, providing professionals with POC
HIV testing training and guidelines and by participating in the monitoring and evaluation of
POC HIV testing in the province.
Contact Information
For more information about POC HIV testing’s fit with professional scope of practice and/or to
arrange a meeting, please contact:
Provincial Point of Care HIV Testing Program
655 West 12th Avenue
Vancouver, BC, V5Z 4R4
Phone: 604.707.5635
Fax: 604.707.2603
Email: [email protected]
Website: www.bccdc.ca/POC
APPENDICES
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APPENDIX XIV — Recommended Base-Line Qualification for NRACP HIV POC Testers
These qualifications can be used as part of NRACP POC tester job postings or
descriptions in order to facilitate the engagement of qualified candidates into these
positions.
Attitudes:
 Accepting and respectful of diversity, demonstrating a positive, non-judgmental
attitude toward people from various social groups and life paths.
 Culturally aware and competent (regarding both socio and ethno-cultural
considerations)
 Curious and flexible (willing to change).
 Can work collaboratively within systems (to provide broad access to care).
 Able to separate own values and morals from those of others.
 Demonstrates a caring attitude toward others.
 Altruistic – able to provide person-centered care.
Knowledge
 Literacy – is able to read and write at a basic level.
 Numeracy – can work with numbers to the extent required to conduct POC testing.
 Basic knowledge (experience a definite asset) of issues faced by populations
vulnerable to HIV. (i.e. Addictions, men who have sex with other men, sexual diversity
etc.)
 Knowledge of community resources (both health care and social services systems).
 Understands privacy considerations and can demonstrate a sensitivity to issues
related to confidentiality.
 Understands trauma informed care, and factors that contribute to person’s
vulnerability. Integrates this knowledge into developing approaches to care.
Skills
 Basic communications skills – ability to listen, process and respond appropriately.
 Interpersonal skills – able to give and take to resolve conflict.
APPENDICES
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APPENDIX XV — Competencies for Non-regulated and Allied Health Care Providers
These key competencies are meant to frame and inform the design of training
sessions and ongoing assessment of competencies for NRACP POC testers. Please
see Appendix XVI for an example of training curriculum components.
Conducts
HIV Test
Informed
Consent
Documentation
Testing
Environment
Confidentiality
Social
Context
Boundaries
PersonCentered
Care
Competencies
for NonRegulated Care
Providers
Self Care
The attitudes, knowledge, skills and judgment (“competencies”) for non-regulated and allied
health care providers (NRACP) to conduct HIV testing were identified by a literature review
and community-based care-givers in focus groups conducted in three separate regions of
British Columbia. These competencies are grouped here with the standards of practice
identified by the same groups. In this document the person conducting the test is referred to
as the “provider” or “NRACP”, and the person receiving the test is referred to as the “person”.
Standard 1 –Person-centered Care:
i. Builds and sustains person-centered relationships as the focus of approach to HIV
testing. Advocates that the interests of the person are at the forefront of their
agency’s approach to HIV testing service delivery.
ii. Demonstrates compassion and respect in the care provided to all people from
diverse backgrounds by providing care that is free bias and prejudice.
APPENDICES
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iii. Demonstrates trust by collaborating with the person to make decisions related to
his or her care. Facilitates opportunities for the person to test in an environment
that best suits his or her needs.
iv. Assures that the language and approach is clear, understandable, and acceptable
to the person who is receiving care.
v. Understands trauma informed care, and factors that contribute to person’s
vulnerability. Integrates this knowledge into developing approaches to care.
Standard 2 –Boundaries:
i.
Does not allow his or her personal or private interests to interfere with providing
care.
ii.
Recognizes and challenges any situation in which the person’s dignity or rights
are interfered with by the power imbalance that exists between service providers
and person.
iii. Recognizes when conflicts interfere with providing care, and takes measures to
protect the person. (E.g. removing him or herself from situations that are
ethically uncertain and refers the person to another provider.)
iv. Assures that all physical contact is for therapeutic purposes, and is helpful to,
and desired by the person
v.
Reports unsafe, harmful or unethical practice of other providers.
Standard 3 –Confidentiality:
i.
Applies current best practices to protect the private and personal information
about the person.
ii.
Understands and informs the person of the limits to confidentiality as laid out in
law and the ethical standards, policies and practices of their organization.
iii. Challenges people and situations where the person’s private information is not
being protected, and reports situations where the person’s confidentiality is
persistently being breached.
Standard 4 - Conducts HIV Test:
i.
Demonstrates skill using available HIV test kits.
ii.
Assures that the person understands HIV, how it is transmitted, and the nature
and limitations of the test that is being used.
iii. Addresses any questions and concerns the person might have, and determines
if the person is ready to test.
iv. Assures supports are in place in the event of a positive diagnosis.
v.
Understands that reportable disease follow-up is part of HIV testing, and
collaborates with the communicable disease team to report and manage new
HIV positive results.
Standard 5 – Informed consent:
i.
Clearly states the purpose and process of HIV testing to the person so that the
person is able to fully understand and agree to be tested.
ii.
Assures that the person receives adequate information to agree to, or decline
testing.
iii. Assures that consent is voluntarily given, and does not coerce the person to
agree to test if that is not the person’s will.
APPENDICES
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iv.
iv.
v.
Understands that consent can be withdrawn at any time, and accepts the
person’s right to change his or her mind about testing.
Bases the person’s capacity to give informed consent solely on their ability to
demonstrate their understanding the test and services that are being provided.
Understands that people with chronic mental health challenges or those who use
alcohol and drugs may still be capable of providing informed consent.
Obtains a signed consent form to transmit confidential information.
Standard 6 – Documentation:
i.
Accurately records discussions, decisions, actions, plans and referrals regarding
the person’s care and status, and signs all documents related to the person’s
care.
ii.
Documents the person’s statement of voluntarily consenting to test.
iii. Collaborates with the communicable disease team from the Health Authority
about how documentation related to new HIV positive results and follow-up will
be coordinated and recorded.
Standard 7 – Testing Environment:
i.
Offers HIV testing only when education, monitoring, and evaluation systems are
in place to assure the competent delivery of HIV testing services.
ii.
Assures the person has access to the necessary follow-up services, including
arranging for the person to have a laboratory HIV test to confirm a point of care
positive test result.
iii. Advocates for a process whereby ethical dilemmas can be resolved within the
workplace.
iv. Employs multiple and creative approaches to delivering care that provides the
person with minimum barrier services. Collaborates with other agencies to
reduce restrictions to access to safe and culturally attuned services.
Standard 8 – Social Context:
i. Determines the local circumstances surrounding populations at risk for HIV within
their specific community.
ii. Assesses and responds to the community’s level of readiness and willingness to
respond to issues related to delivering HIV testing services.
iii. Works with individuals and groups from the community to develop services that
are acceptable within the community setting, and address the needs of the people
who are at risk for HIV.
iv. Employs knowledge of socially-based contributors to vulnerability for acquiring
HIV (such as stigma, discrimination, poverty, and homelessness) in community
development. Provides education and support to the community to increase the
level of knowledge related to HIV risk and service needs.
Standard 9 – Self Care:
i. Employs external and self-care measures to deal with the emotional stress of
providing HIV testing services.
ii. Advocates for adequate support services for HIV test providers.
APPENDICES
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Page 77
APPENDIX XVI — HIV Testing Education for Non-regulated and Allied Health Care
Providers
Module I: HIV in Canada and BC, standards for HIV testing, population approaches to
HIV testing and prevention and guiding principles when working with individuals

HIV In Canada and British Columbia

How knowledge, engagement , relationship building and assessment contribute to
effective testing, prevention and support efforts

Population & Public Health Approaches to HIV Testing

Working with Individuals
o
Benchmarks for informed consent
o
Person Centred Care – What does this look like?
o
Effective communication – include demonstrating of communication skills
o
Confidential Care, the limitations of confidentiality and the consequences for
breaches of confidentiality
o
Culturally competent care
o
Include the cultural competence course
o
Boundaries - Establishing and maintaining Client/provider boundaries – steps to take
when boundaries become blurred
o
Ethics and HIV testing
o
Documentation
Module 2: The Virus –HIV as a pathogen and a disease, the impact of HIV at the
cellular, individual and population levels

What is HIV

HIV Transmission

HIV and the Immune System

o
HIV Replication
o
The Course of HIV Infection
o
Progression of HIV - Untreated
o
Progression of HIV - Treated
Treatment and Prevention
Module 3: Individual and population issues which impact vulnerability to HIV

Who is Getting HIV in BC

HIV Rates per Health Authority

Working with Individuals who have increased vulnerability to HIV
APPENDICES
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Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 78
Module 4: HIV Tests – The characteristics of the POC test and the lab test

Characteristics of HIV Tests
o

http://www.bccdclearning.ca/moodle/mod/book/view.php?id=1449&chapterid=1141
Window periods of the POC and Lab tests
o

Biological Markers
Standard Lab Tests as a confirmation of the POC test
False Positive Results
Module 5: Provider responsibilities prior to testing.
Prior to HIV testing

Assessing and responding to person’s knowledge of HIV and HIV testing

Describing the different POC test results

Discussing benefits as well as possible personal challenges of knowing HIV status

Assessing a persons readiness to test

Supporting the person who is vulnerable and decides not to test for HIV

Discussing a person’s support network

Next steps if negative or preliminarily positive
Module 6: Performing HIV POC Tests – This module will train the person in use of the
POC test kit including the quality control issues which accompany its use.
http://www.bccdclearning.ca/moodle/mod/book/view.php?id=1493&chapterid=1255POC
Provincial Training Program
Module 7: Discussing POC results. Introduces HIV reporting, the legal implications of
HIV non-disclosure and the benefits of clinical follow up when HIV positive



The POC test result is negative
o
How to discuss the result
o
Responding in a person centered way
o
Consideration of window period
o
Community referrals
The POC test result is indeterminate or invalid
o
How to discuss the result
o
Next Steps
The POC test result is reactive
o
How to discuss the result
APPENDICES
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Point of Care HIV Test Guidelines for Health Care Settings
May 2014
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
o
Responding in a person centered way
o
Pathway for confirmatory testing
o
Prevention messaging while waiting for results – protecting partners
o
Community referrals
The BC HIV reporting process
o


How to report a preliminary positive POC result – nominal / non nominal
Talking with HIV positive persons about their partners
o
How to talk with newly diagnosed persons about informing partners.
o
How public health nurses can assist with partner notification.
o
Is partner notification mandatory or voluntary?
o
What is the role of the testing provider around discussing disclosure and non
disclosure of HIV status?
o
Provider next steps around non disclosure if another person may be being exposed.
Where to find current legal information about disclosure
Module 8: Possible impacts of providing HIV testing on an individual provider

Exceptional issues which could occur when testing peers – guest speaker from the HIV
community

Recognizing personal provider stress –self care

Debriefing when working on a team

Lines of team communication

Ethical challenges in HIV testing
Module 9: Clinical Practice – An opportunity to demonstrate understanding of HIV
testing guidelines, skills performing POC HIV testing and interpreting results.
Participant will be aware of ongoing competency requirements established by
employer
Preceptored Practice

Observing an expert performing POC testing

Observation of practice by an expert – giving both negative and preliminary positive
results

Evaluation

Certification of completion

Ongoing competency requirements
APPENDICES
Communicable Disease Control Manual – Chapter 5
Point of Care HIV Test Guidelines for Health Care Settings
May 2014
Page 80
APPENDIX XVII — Checklist for New NRACP Sites
Implementation Checklist for NRACP HIV Testing Sites
1. Initial Engagement - Review the following:
 Rationale for additional HIV testing
 Context of the clinical program
 Leadership and operational roles
 Will site be supported by BC POC HIV Test Program or test independently?
2. Site Preparation
 Who will fill leader and operational roles for implementation?
o Use Roles and Responsibilities Appendix II
 Client volumes – how many clients are served per year?
 Training and Go live dates
o Training should be as close to go live as possible.
o Modify Curriculum
o What content needs to be customized?
3. On‐Site readiness
 Confidential and appropriate space for client testing?
 Safe and secure client record storage?
 Plan for disposal of hazardous waste?
 Infection control plan?



3a. Confirmatory Lab testing
What process does the site currently follow to refer or conduct HIV tests?
Reporting reactive results – who to contact and what support does the client need?
Who will order confirmatory HIV tests?




3b. Reporting POC testing
How are POC tests results/usage reported?
How is usage of POC tests reported to BCCDC?
What is the POC recall process – who leads this at this site?
How are POC test kits and supplies ordered? Who does this?
4. Client Support Materials
 Client information brochure about HIV testing
 Posters for clinic rooms and waiting area
 HIV POC Support Materials
 HIV POC instructions
 What to do with a reactive result?
 Lab vs. HIV POC testing guide
 BCCDC HIV POC Testing guidelines
 Testing frequency recommendations (M. Gilbert)
 Referral resources for HIV primary care and supports
APPENDICES
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May 2014
Page 81
5. Training
 What training is needed?
 How will the training be provided?
 How will competence be assessed? By whom? How often?
o Schedule staff for POC training (online or in-person options)
o HIV Pre‐Post test counselling
o On site shoulder to shoulder training for new testers
o Review POC test mechanics
o How to record POC tests on the testing log
o Reporting reactive results to MHO/Designated Nurse
o Support strategies for clients with reactive test results
o How to order HIV POC materials
o How to dispose of test materials safely
o Infection control procedures
o Sample collection and transport procedures
o Review plan for storage of client records
o Other needs
6. Check‐in
 Identify any barriers to testing
 Identify any successes
 Identify any problems in operational processes
 Address problems identified
 Share testing level progress (# tests administered)
APPENDICES