Point of Care – Quality Assurance Program

Policy

Category: Clinical Services
Subject: Point of Care – Quality Assurance Program
Division: Community Health and Wellness
Policy Number: CA.72.01.400
Effective Date: October 26, 2017

POLICY STATEMENT

Point of Care (POC) testing for HIV is available at the Chancellors Way office and brought to off-site testing events for specific populations: men who have sex with men, injection drug users, African Caribbean Black (ACB) persons and women who have sex with any of the previous categories.

Nurses providing POC testing must be certified. A designated nurse in the Clinical Services program is identified as the POC supervisor who is responsible for staff training, certification, refresher training and POC Quality Control measures. The POC supervisor is responsible for POC test kit ordering and inventory.

POC test kits are provided to public health by the AIDS Bureau of the Ministry of Health and Long-Term Care. Stringent criteria has been establish by the Ministry regarding the POC testing program which includes a Quality Control/Quality Assurance program.

SCOPE

This policy applies to all WDGPH nurses certified to provide POC HIV testing.

DEFINITIONS

POC Testing - a testing process that provides the client results within minutes of test. 

REFERENCES AND RELATED FORMS, POLICIES AND PROCEDURES

Corresponding Procedure:  CA.72.02.400 Point of Care – Quality Assurance Program

CONTACT FOR INQUIRIES

Manager, Clinical Services

APPROVED BY

Director, Community Health and Wellness


Procedure

Category: Clinical Services
Subject: Point of Care – Quality Assurance Program
Division: Community Health and Wellness
Procedure Number: CA.72.02.400
Effective Date: October 26, 2017

PROCEDURE

Staff Training: 

  1. All Wellington-Dufferin-Guelph Public Health (WDGPH) staff responsible for Point of Care (POC) HIV testing must successfully complete a training program that includes the following criteria:
  • Biosafety;
  • Performance of the test;
  • Interpretation of results; and
  1. Quality Assurance (QA)/Quality Control (QC) procedures.
  2. The nurses must correctly test and interpret the results of a competency assessment panel before performing POC HIV testing on clients.
  3. The nurse will receive a certificate once they pass the competency assessment.
  4. The nurse must also participate in periodic refresher training.
  5. All related documentation pertaining to training and certification must be forwarded to Human Resources for inclusion in the employees file. 
  6. A nurse per office will be assigned as the lead or POC supervisor to monitor the POC QC practices and report outstanding issues to the manager, AIDS Bureau and Public Health Laboratory (PHL) that supplies POC kits as required.

Kit Lot Release Program:

  1. The AIDS Bureau will retain copies of the Certificate of Analysis (COA) on file for future reference.
  2. Before using kits from a new lot, one of the certified nurses will perform a validation testing.
  3. Nurses will ensure that lot number and kit expiry date are recorded on the POC HIV Testing Record- Daily Log for each test performed.

Internal Quality Control (Kit Lot Validation & Running Controls):

  1. A certified nurse will be assigned responsibility for performing control testing.  It is the responsibility of all certified nurses to ensure proper validation has occurred before using tests with a client.
  2. Each shipment of new kits must be checked to ensure these kits perform properly. The assigned nurse will run positive and negative internal QC specimens provided by the manufacturer on each new kit lot.
  3. In addition positive and negative controls must be conducted on a routine basis as follows: 

Test Volume           Time Frame   QC Testing

0-25 tests                  Per month       Monthy
26-124                      Per month       Monthly or at least 125 tests, whichever comes first
125 tests or more      Per week        Weekly

  1. The nurse completing the positive and negative control testing will record the results in the logbook and notify the manager and the AIDS Bureau of any discrepancies. 
  2. Ensure all kits from existing shipments are used before starting to use kits from a new shipment.

Validating a new shipment of kits and run routine quality controls:

  1. When a new shipment of POC HIV test kits is received the assigned nurse will separate these kits from other kits currently in use.
  2. Record the lot number and number of tests received in the POC Inventory Log and in the online AIDS Bureau POC Inventory System.
  3. The assigned nurse sets up for an internal quality control testing.
  4. Use one new kit to test the positive control material.
  5. Record the internal QC results for the positive control in the HIV POC Testing Record Daily Log and Quality Control Log.
  6. Use another kit to test the negative control material.
  7. Record the internal QC results for the negative control in the HIV POC Testing Record Daily Log and in the Quality Control Log.
  8. If the internal positive and negative QC results are acceptable (i.e. correct) the kits can be identified as acceptable for use.  These kits will be kept in the cupboard labeled “ready to use”.
  9. If the results are not acceptable (i.e. incorrect or invalid) notify manager and the AIDS Bureau immediately and ensure kits are not used for client testing.

Note: Control panels containing positive and negative specimens are shipped frozen, and must be stored in a freezer until expiry date. When ready to use, remove from freezer to thaw and use as directed.  Once thawed, must be left in monitored fridge (2-8 degrees C) for up to one year.    

Routine Quality controls: 

  1. The assigned nurse sets up for an internal quality control testing.
  2. Use one new kit to test the positive control material.
  3. Record the internal QC results for the positive control in the HIV POC Testing Record Daily Log and Quality Control Log.
  4. Use another kit to test the negative control material.
  5. Record the internal QC results for the negative control in the HIV POC Testing Record Daily Log and in the Quality Control Log.
  6. If the internal positive and negative QC results are acceptable (i.e. correct) the kits can be identified as acceptable for use.
  7. If the results are not acceptable (i.e. incorrect or invalid) notify the POC supervisor immediately and ensure kits are not used for client testing.

Invalid or unacceptable test results when validating kits or running controls:

  1. An invalid or unacceptable QC result indicates there is a problem either with the testing process, the control material or testing device. All follow-up action must be documented.
  2. Record unacceptable result (test 1) in the Incident Log including description of type of unacceptable result and all follow-up action.
  3. Retain all devices used for unacceptable QC testing. Place kit contents in plastic bag and label bag indicated test number 1.
  4. Repeat the testing of both the positive and negative testing (test 2) using the same material and batch of kits. Ensure QC specimens are tested sequentially and not simultaneously.
  5. Record the results of test 2 in the Quality Control Log and the Incident Log.
  6. If the test results of test 2 are acceptable, carefully consider what may have contributed to the previous unacceptable results, record all findings in incident log and proceed with testing of clients.
  7. If results of test 2 are unacceptable. Repeat the testing of the positive and negative using new unopened control material (test 3).
  8. If results of test 3 are acceptable repeat the test once more (test 4) using the same control materials used in test 3. If the tests continue to be acceptable than the problem is related to the control material, not the kits. Consider possible errors related to the control material.
  9. If the results of test 3 or test 4 are unacceptable: All HIV POC testing must stop immediately. Notify AIDS Bureau and PHL.
  10. Retain all devices used when unacceptable results were obtained.  Store in plastic bags labeled as to test number.
  11. Complete the Incident Log full and accurately.
  12. Review testing with POC supervisor if process proceeds beyond test 1.

Invalid or unacceptable rest results when testing a client:

  1. An invalid or unacceptable test result when testing a client may indicate a problem either with testing process, the blood sample or testing device (refer to manufacturers guidelines).
  2. Record invalid result (test 1) in the Incident Log.
  3. Retain the device used in the invalid test by placing it in a plastic bag labeled test 1.
  4. Repeat the test (test 1) using a new kit.
  5. If results of test 2 are valid, carefully consider what might have occurred during the first test and proceed with client counseling.
  6. If results of test 2 are invalid, records results in the Incident Log and retain all testing devices by placing them in a plastic bag labeled test 2.
  7. Recommend the person be tested using standard HIV testing.  Refer to policy CA.72.01.402 HIV Testing.
  8. Report invalid test results to manager for investigation. 

Proficiency Testing:

  1. Each Wellington-Dufferin-Guelph Public Health (WDGPH) designated POC HIV testing site and certified staff will participate in proficiency testing using blind specimens sent twice a year.
  2. Each certified nurse is expected to perform testing on a rotating basis.
  3. Any errors in proficiency will be reported immediately to POC supervisor and if necessary the manager, or investigation and corrective actions taken and documented.
  4. The POC supervisor will maintain a record of all proficiency testing.

Parallel Testing:

  1. Parallel testing allows sites to compare POC HIV test results with those results obtained by standard HIV testing done at the PHL. This will occur automatically in certain situations:
  • When POC HIV test results are reactive, then a venous blood sample will be taken and sent to PHL for confirmatory testing; and
  • When POC HIV test results are non-reactive, client is high risk, symptomatic and in the window period, then a venous blood sample will be taken and sent to PHL for standard HIV test and p24 testing.
  1. Results from POC and PHL testing should be documented and compared. The AIDS Bureau and the PHL should be notified of any discrepancies. Testing sites should keep track of the proportion of HIV negative clients who have a reactive POC HIV test result, and proportion of invalid POC tests.

Procedure:

  1. For all specimens, forward to PHL for addition testing, record details in the POC HIV Testing Record Daily Log.
  2. Upon receiving lab result from PHL, record results including EIA, WB and p24 antigen (if done) in the POC HIV Testing Record Daily Log.
  3. Compare POC test results and PHL results.
  4. Report any false negative results on POC testing to the manager who will notify the AIDS Bureau and PHL immediately.
  5. Complete the Monthly Summary Data Report and calculate the percentage of false reactive results and proportion of invalid tests results report the following:
  • If >0.5% of POC tests are false reactive, notify the POC supervisor who will contact AIDS Bureau and PHL; and
  • If more than 1% of tests are invalid, notify AIDS Bureau.

Kit Inventory:

The assigned nurse for quality control will monitor the supply of testing kits/control samples in stock, and will use the “HIV Point of Care Testing: Online Inventory System” to order kits, Quality Control Samples, and Staff  Validation/Certification Panels.

Environmental Monitoring:

  1. Kit storage and testing areas must be monitored for temperature daily. The POC HIV test kits must be kept at the temperature that is recommended by the manufacturer. Temperature gauges must be used to record current temp, maximum and minimum temperature over a period of time.
  2. The assigned nurse will ensure daily temperatures are taken each working day using a minimum/maximum thermometer and recorded on the Environmental Monitoring Log. Any temperatures outside the acceptable range must be reported to the POC supervisor for follow-up.
  3. QC samples have an expiry date and must be kept frozen until ready to use.  Once they are thawed, must be kept at 2-8 degrees C, and are good for one year.

Documentation:

  1. All QA program documentation is maintained for 10 years, including the following:
  • Standard operating procedures for the POC HIV testing;
  • Records of staff training, competency, and ongoing education;
  • Client results recorded in the client file (include kit lot, tester ID, date);
  • A central log of testing results showing the date, kit lot, tester ID, client ID, relevant QC testing, parallel testing;
  • Monthly summary of false negative/positive/invalid results obtained from POC HIV testing;
  • Inventory control system to monitor kit lot and product availability;
  • Incident log (incorrect QC or other discrepancies, investigations, and corrective actions will be recorded;
  • Temperature control and environmental monitoring log for areas where kits are stored; and
  • QC results are recorded in a QC file and reviewed at regular intervals by the supervisor (at least monthly).

The Assigned Nurse will:
 
Daily:

  • Monitor temperatures and document in Environmental Monitoring Log (this can be assigned to a trained designate support staff).

Weekly:

  • Review POC HIV testing log and follow-up on any positive results, additional testing sent to PHL, or invalid results; and
  • Assess inventory of POC kits and QC samples.

Monthly:

  • Complete the Monthly Summary Data Log at the end of each month.

As needed:

  • Perform routine quality controls on POC kits depending on frequency of tests being done (refer to page 2); and
  • Order supplies as needed.

REFERENCES AND RELATED FORMS, POLICIES AND PROCEDURES

Corresponding Policy:  CA.72.01.400 Point of Care – Quality Assurance Program

CA.72.01.402 HIV Testing
HIV POC Testing Record Daily Log
Quality Control Log
POC Inventory Log
Incident Log
Environmental Monitoring Log

AIDS Bureau, Ministry of Health and Long‐Term Care. Policies, Procedures and Quality Assurance fo

CONTACT FOR INQUIRIES

Manager, Clinical Services

APPROVED BY

Director, Community Health and Wellness