Transcript Slide 1

CONTACT INFORMATION:
Robin L. Gorman
Rapid HIV Testing in Delaware
Delaware Public Health Laboratory
30 Sunnyside Road
Smyrna, DE 19977
Frederick P. Franze, MT (ASCP), Robin L. Gorman, MLT (ASCP), Jane P. Getchell, DrPH
[email protected]
Tel:
302.653.2870
Fax:
302.653.2877
ABSTRACT
In March 2003, the Delaware Division of Public Health began rapid HIV-1
antibody testing at one of the four STD clinics within the state. All four sites
were performing the test by June 2003. Each of these clinics conducts
moderate complexity testing under a single CLIA certificate that allows
multiple state laboratories to engage in limited public health testing under
one certificate. Prior to implementation, the HIV program office worked with
the Public Health laboratory to develop a comprehensive quality assurance
program for rapid HIV testing. The technical supervisor (TS) for the STD
clinics was tasked to develop appropriate logs and training materials
necessary to train the staff. To decrease the chance of error, clinics were
trained and authorized to begin testing one at a time. Beginning December
2004, a community-based organization was authorized to begin testing
through a contract with the HIV program office. This site is required to follow
the same training and QA as the state STD clinics.
Documents used for rapid testing (training, QC, etc) were designed utilizing
the CDC QA guidelines. OraSure Technologies provided training to our TS,
who then provided training to all public health staff involved in testing.
Training was conducted in the following manner: first the laboratory staff
were trained to perform the test and competency assessment was
documented, then the HIV program office held a meeting with lab staff,
clinicians and counselors to discuss protocols for testing and reporting.
Once it was determined that all staff were ready to begin, permission was
granted to begin testing patients. The first 100 patients tested using rapid
tests were backed up with ELISA to validate the method.
The virology section of the Public Health laboratory put together several sets
of “unknowns” for proficiency testing. All staff wishing to perform rapid
testing were required to successfully interpret the results of these samples.
Quality assessment consists of the following:
- On-going QC measures as required by the manufacturer
- Proficiency testing using the CAP Anti-HIV-1 antibody – waived survey
(RHIVW)
- CDC MPEP for rapid testing
- Semi-annual inspections of the five laboratories involved in testing by
the TS
All preliminary positive rapid tests are sent to the state public health
laboratory for confirmatory Western Blot test.
For calendar year 2004, Delaware tested 6141 patients, with 78 confirmed
preliminary positives and two false positive rapid tests. All five testing
locations successfully passed all proficiency testing surveys and no
erroneous results due to technician error were reported.
INITIAL CONCERNS
QUALITY ASSURANCE
• Training: Who would be responsible for training clinic staff to perform testing? Who should be trained?
 Allows multiple laboratories to engage in public health testing under one certificate.
- Initially, only lab techs would be trained to perform the test.
 Provides unique opportunity to implement a comprehensive quality assurance program for all sites
performing rapid HIV testing throughout the state. Performance is monitored via semi-annual
inspections.
• Validation: How do we want to validate the test?
- The first 100 patients tested using rapid tests were backed up with ELISA testing
• Quality Control: At what intervals should QC be performed?
- External quality control to be done at the following intervals:
2. Each day of testing for staff who perform the test on an irregular basis.
- Quality control is to be performed whenever a new lot of kits is received & put into use.
- Whenever testing personnel suspect there may be a problem with the test kits.
• Proficiency Testing (PT): What PT surveys should be performed?
- All sites were enrolled in the College of American Pathologist’s PT survey for rapid HIV
testing (RHIVW)
- All sites participate in the CDC Model Performance Evaluation Program (MPEP) for rapid
HIV testing.
- To be certified to begin patient testing, lab staff had to demonstrate proficiency by accurately
interpreting the results of several “unknown” specimens.
- Documentation was accomplished using a modified version of the CDC training checklist for the
OraQuick® rapid HIV-1 antibody test.
- After staff were certified to perform testing, the HIV program office and the Public Health lab held a
meeting with clinicians, counselors and testing personnel to discuss protocols for testing and reporting.
Delaware Public Health Laboratory
Training Checklist for the OraQuick® Rapid HIV-1 Antibody Test
Employee: _________________________________ Clinic: ________________________
- Designated the STD clinic lab technical supervisor as the authorized
individual to train and certify public health staff to perform rapid testing.
- Developed the appropriate logs and training materials.
- Monitors the following quality assurance activities at each of the
authorized testing locations: quality control, PT surveys and technician
performance.
- Maintains and distributes rapid testing supplies to test sites.
Trainer’s Initials and Date
• Located in lab and available?
Y
N
• Reviewed by all staff performing tests?
Y
N
b. Problem / Sharps Injury Log
• Located in lab?
Y
N
• Any entries requiring review/action?
Y
N
Y
N
c. Is the CLIA Laboratory Certificate of Compliance posted?
a. Gram Stain QC performed as required?
Y
N
N/A
b. Syphilis Serology QC performed as required?
Y
N
N/A
c. Rapid HIV QC performed as required?
Y
N
N/A
d. Refrigerator, Incubator & room temps recorded?
Y
N
3. Lab Safety / Standard Precautions: ensure that the lab is being operated in a safe
manner.
25
25
Kent County
Health Unit
Dover
(Kent County)
134,390
1782
6
6
Sussex County
Health Unit
Georgetown
(Sussex County)
168,027
748
19
18
Shipley State
Service Center
Seaford
(Sussex County)
197
3
2
and
- Several false positive specimens were sent to OraSure Technologies
for evaluation. It was determined that the patients had a non-specific
binding antibody that reacted with proteins used in the test paddle
matrix.
CONCLUSIONS
Y
N
b. Is the appropriate PPE available and used as needed?
Y
N
c. Are sharps disposed of properly?
Y
N
Through the use of the CLIA Limited Public Health Use Exception
(certificate), the Delaware Public Health laboratory was given the unique
opportunity to implement and monitor a comprehensive quality assurance
program for all sites performing the rapid HIV test throughout the state.
Y
N
Key components of this QA program include:
Y
N
d. Is there evidence of eating/drinking/storage of food
in the lab?
e. Is a biological spill kit readily available?
date opened/prepared, expiration date, initials.
● Standardized training program for all testing sites
● Standardized quality control requirements for all sites
f. Are all reagents, solutions & tests kits labeled with:
Y
N
● Standardized proficiency testing program.
● Standardized testing and reporting procedures for all clinic sites.
4. Comments / Recommended Corrective Action:
● Standardized requirements for confirmation testing of preliminary
positive results and follow-up of discordant results
The creation of a standardized quality assurance program, run by a
single technical supervisor, who is able to monitor the performance at all
testing sites, has been instrumental in assuring that no erroneous results
due to technician error have occurred.
Evaluate a new OraQuick® test
kit lot number and record results
in QC log
REFERENCES
Collect & send specimen for
confirmatory testing at DPHL
Perform proficiency test proved
by DPHL and obtain correct
results
1019
a. Is the lab clean and operated in an organized manner?
Record external quality control
(QC) results in QC log
Explain procedure to follow if
QC results indicate a problem
28
2. Quality Control / Maintenance Records: ensure that QC and maintenance records are
completed as required, and available for review.
N
Record results on report form
and log sheet – route report
form copies & results
appropriately
28
- Preliminary positive rapid tests that were confirmed positive by
Western Blot usually demonstrated a clear, strong band at the “T”
region within two to five minutes after the test began.
(indicated by staff signature)
Y
Insert test device, time test,
correctly interpret result
2395
Since beginning rapid testing in March 2003, the five site labs have
performed 9,058 tests. Of the 117 tests reported as preliminary positive,
110 were confirmed by Western Blot. The remaining seven tests were
determined to be false positive results. During this time the following
observations were made:
a. Laboratory SOP manual:
f. Does all lab equipment function properly?
HIV Program Office
515,074
TEST RESULT OBSERVATIONS
1. Administrative: ensure that the required manuals, logs & certificates are available as
required.
Determine if requirements for
acceptable testing environment
are met (temperature, lighting,
proper work space
Dispose of lancet and other
biohazardous waste
appropriately
Wilmington
(New Castle
County)
Georgetown
Facility: ________________________ Date: ______________
N
To facilitate implementation of rapid testing, the HIV program office worked
with the Public Health laboratory to develop a coordinated approach.
Responsibilities for each included:
Porter State
Service Center
STD Clinic Lab Inspection Report
Y
Collect finger-stick specimen,
put loop into vial and mix
correctly
#Confirmed
Seaford
e. Are problems with QC/ maintenance documented as required
is the problem resolved?
Label test device components
and appropriate paperwork
Dover
- Discordant (false positive) rapid test results are investigated to ascertain the cause.
Read OraQuick® procedure
and view rapid test training
video
Explain requirements for “Subject
Information” brochure
#PP
Division of Public Health
- The technical supervisor provided training to the laboratory technicians at each of the STD labs utilizing
a video tape of the test procedure and hands-on training.
Practice test with negative and
positive external controls
Total Tests
Performed
- All Preliminary Positive specimens are sent to the Virology section of the DPHL for
confirmatory Western Blot testing.
- OraSure Technologies provided initial training to the technical supervisor for the STD clinic labs.
Trainee’s Initial and Date
County
Population
- All sites test commercially prepared Quality Controls (Positive & Negative) as specified in the
SOP manual.
The OraQuick® rapid HIV-1 antibody test training program was implemented in the following manner:
Date Performed
Location
- All sites participate in the CDC Model Performance Evaluation Program (MPEP) for HIV rapid
testing.
TRAINING
Instructions: Fill in dates when the trainee observes and performs each objective or procedural
step, as applicable. (If a trainee will not perform a specific task, enter N/A for not applicable) The
trainee should initial when he/she feels the objective/procedure has been mastered and the trainer
when he/she thinks the trainee has met the objective or performs the specific procedure
competently.
Public Health Laboratory
- All sites are enrolled in College of American Pathologist’s PT surveys for rapid HIV-1 antibody
testing (RHIVW).
Test
Beautiful Gate
Outreach Center
(communitybased
organization)
 DE Quality Assurance program consists of the following:
- Survey participation and performance is monitored by the technical supervisor.
In January 2003, the FDA approved the OraQuick® rapid HIV-1 antibody
test as a CLIA-waived test. In March 2003 the Director of the Division of
Public Health gave approval to the HIV program office and the Public
Health laboratory to begin implementing rapid HIV-1 testing throughout the
state. The rationale for granting quick approval to implementation was
based upon the fact that in calendar year 2002, approximately 10,000 HIV
tests were performed (both anonymous and confidential), but 46% of the
clients failed to return for their results. This created a situation whereby a
large population is potentially at risk of infection and don’t know it. It is
believed that the primary reason for this high “failure to return” rate was the
long turn around time (two weeks) for results. By implementing rapid
testing at the clinic sites, clients will be able to learn their HIV status
immediately, allowing clinic staff an opportunity to discuss risk reduction
and behavior change.
- Determined which clinic sites would be authorized to perform the
testing and who would be trained to perform testing (clinicians,
counselors, etc).
Wilmington
- All clinical staff trained to perform the rapid test must demonstrate competency prior to testing
patients.
1. Weekly for staff who perform the test on a daily basis
Objective / Procedural Step
Testing Statistics 2004
- Standardized SOP’s for all testing sites.
Trainer: ____________________________________
- Provide the funding to purchase test kits, controls, training materials
and Proficiency Testing surveys.
The STD clinic labs perform testing under the CLIA Limited Public Health Use Exception (certificate).
- The technical supervisor for the STD clinic labs was tasked with the responsibility
BACKGROUND
Beginning March 2003, STD clinics were authorized to begin testing, one at
a time. As each site began testing, close, coordinated communication was
maintained between the HIV program office, the Public Health lab and the
clinic staff to resolve any problems or issues as they occurred. By June
2003, all four of the STD clinics were performing testing. In December
2003, a community-based organization (CBO) was authorized to begin
testing.
DELAWARE
__________________
______________________
• OraSure Technologies, Inc. OraQuick® Rapid HIV-1 Antibody Test
(Inspector Signature)
(Staff Member Signature)
Package Insert (Rev. 10/03)
• CDC Quality Assurance Guidelines for Testing Using the OraQuick®
Rapid HIV-1 Antibody Test