Point of Care testing may seem, on its face, simple and 'fool proof', but
in a study conducted by the Health Care Financing Administration (HCFA - now
referred to as CMS) in Colorado and Ohio, quality problems were
identified in more than 50% of Certificate of Waiver labs surveyed nationwide.
This study revealed "glaring quality control problems" and urged the FDA to
provide more governmental oversight of these laboratories. The HCFA study noted
problems in 50% of the laboratories surveyed and specifically cited the
following performance problems:
o Obsolete instructions
o Lack of instructions
o Incorrect instructions
o Failing to perform quality control
as required by the manufacturer.
The NJ HIV program is designed to assist
personnel engaged in Rapid HIV Point of Care testing to achieve the following goals:
- To provide quality care to clients;
- To meet the standards of quality review organizations;
- To insure compliance with state and
federal regulations regarding laboratory oversight;
- To provide consistency of test offerings within
the NJ HIV program;
- To achieve economies of scale in the acquisition of reagents and
To insure the highest quality of test performance
Under this program a standard package of Point of Care services are
available at each clinical facility, so long as the required training,
proficiency testing, quality control procedures and validation procedures are
performed by the clinical staff in the facility. The Robert Wood Johnson Department of
Pathology and Clinical Laboratory Medicine oversees this program and provides Bioanalytical Laboratory
Directorship (BLD) and all necessary state and federal licensing for each
is responsible for:
- Submission and maintenance of clinical laboratory licensure
written procedures, a training program,
a competency assessment program,
a proficiency testing program, a quality control program and an
internal laboratory inspection program.
reagents will be provided through the program and lot to lot
variability minimized by centralized bulk purchasing and central validation of reagents
- Troubleshooting support will be provided to insure testing quality along with standardized procedure for reporting testing
exceptions and problem resolution
- A team of clinical laboratory specialists will periodically inspect facilities to
continued compliance with state and federal regulations at least semi-annually and
more frequently, if necessary.
To participate in Point of Care Testing involves three simple steps:
Completion of a facility survey.
The purpose of the facility survey is to ascertain all clinical laboratory
testing being conducted on premises. The Department of Pathology
and Laboratory Medicine will then arrange for a site inspection and
submit a NJ clinical license on behalf of the
- Arrange for appropriate insurance coverage. Each institution has its
own unique set of insurance requirements. All facilities in which faculty of
the UMDNJ - Robert Wood Johnson Medical School are serving as
Directors/Supervisors or Consultants will need to establish a Professional
Service Agreement. This can be arranged at the time of the initial site
visit. It is designed to insure that appropriate insurance is available for
all participants in the program.
Receipt of procedures and subsequent training.
Upon completion of laboratory licensure, the Department will arrange to provide
training. The Department will
to Point of Care Procedures. Continued participation in the program requires that Point-of-Care Testing be performed
accordance with procedures described in our manuals and include those related
to quality control, recordkeeping, proficiency testing and competency
assessment. Periodic inspections of all sites will occur and the results
will determine continued participation in the program.
Provide procedure manuals and forms. The most current procedure and
forms will be available on this website
Provide staff training. Efforts will be made to provide training at
convenient locations in the State of New Jersey.
Provide competency assessment of newly trained staff
including 'Hands On' testing of unknown specimens
- Provide ongoing review with your staff and
resolution of problematic issues.
- Arrange for
in on-going proficiency testing under an appropriate program, and/or
additional assessments as deemed necessary by the Bioanalytical Laboratory
Obtaining necessary supplies.
including test and control reagents, may be requested by forwarding a POCT
supply request to our Central Administrative Offices in Somerset via fax (732)
235-8113 or by email to
email@example.com. Testing devices will be provided at no charge to a site.
Charges for other supplies will be distributed to the facility
periodically. Testing devices and control reagents will be
validated prior to distribution. If supplies are obtained in any other way it is
obligatory that they be validated by the site prior to use.
The responsibility for successful participation in proficiency testing
is ultimately the clinical sites’. The Department will provide assistance in
troubleshooting of a limited nature. More extensive troubleshooting activities
will be provided on an hourly basis to provide more complex troubleshooting of
procedures on a unit specific basis.