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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.
UMDNJ risks
intervention by both federal and state authorities if clinical testing is
performed in violation of CLIA and NJ State DOH requirements.
To
assist clinical personnel within UMDNJ -
Robert
Wood
Johnson
Medical
School
who wish to perform
clinical laboratory procedures on-site, the University Medical Group has adopted
a medical school-wide POCT program designed:
 | To provide quality care to our patients;
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| To meet the standards of quality review organizations;
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| To insure that Robert Wood Johnson Medical School maintains required compliance with state and
federal regulations regarding laboratory oversight;
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| To provide consistency of test offerings across Robert Wood Johnson
Medical School;
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| To achieve economies of scale in the acquisition of reagents and
instrumentation within the group;
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| To provide additional revenue opportunities for clinical
departments;
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| To simplify billing procedures within the medical school; and
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| To insure the highest quality of test performance to our patients.
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Under this program a standard package of Point of Care services will be
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 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
site.
This
program will:
| Submit and maintain clinical laboratory licensure for any clinical site
providing point of care testing |
| Sites will be supported with written procedures, a training
program, a proficiency testing program, a quality control program and a
competency assessment program in support of POCT.
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| Each participating nursing unit will be provided with a package of
standardized procedures and will be permitted to perform testing so long as
the requirements for training, competency assessment, quality control and
periodic review are maintained within the facility
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| Common reagents will be used throughout the program and lot to lot
variability minimized by centralized bulk purchasing of reagents
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| Limited troubleshooting support will be provided to insure testing quality along with a standardized procedure for reporting testing
exceptions and problem resolution
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| A team of clinical laboratorians will periodically inspect facilities to
insure
compliance with state and federal regulations at least semi-annually and
more frequently, if necessary.
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| Insure compliance with billing requirements
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| Glucose by monitoring device FDA cleared for home use
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| Urinalysis by dipstick, non-automated
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| Urinalysis, microscopic ONLY
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| Urinalysis by dipstick, non-automated with microscopy |
| Pregnancy – Urine pregnancy test by visual color comparison methods
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| Guiac, stool - Blood
occult, by peroxidase activity, feces, 1-3 simultaneous determinations
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| Streptococcus, group A –
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| H. Pylori –
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Physician Performed Microscopy
 | KOH prep
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| Wet mount
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| Fern test
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To participate in Point of Care Testing involves three simple steps:
- Completion of a facility POCT survey.
The first step in licensing POCT activities is the completion of a survey of
clinical laboratory testing being conducted on premises. The Department of Pathology
and Laboratory Medicine will then arrange for a site inspection and appropriate licensure of the
facility.
- Receipt of procedures and subsequent training.
Upon completion of licensure, the Department will arrange to provide
training for any point-of-care procedure from the list of
supported procedures. The Department will:
- Provide POCT instruction manuals and forms to the unit
- Provide staff training
- Provide competency assessment of newly trained staff
- Arrange for site participation
in on-going proficiency testing under an appropriate program, and/or
additional assessment as deemed necessary by the Bioanalytical Laboratory
Director.
- Establish POCT approval for billing purposes,
if required
- Obtain a New Jersey Department of Health and Senior Services (NJDHSS)
Clinical Laboratory Improvement Service (CLIS) License. This step generally
requires completion of prelicensure testing which will be arranged with the
Department of Health and Senior Services. Upon completion of the license
appropriate CLIA registration will be arranged.
- Adhere
to Point of Care Procedures. Continued participation in the Robert
Wood Johnson Medical School-wide
Point of Care program requires that Point-of-Care Testing be performed in
accordance with procedures described in our manual 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.
Obtaining necessary supplies.
Supplies,
including test and control reagents, may be requested by forwarding a POCT
supply request to UDL Central Administrative Offices via fax (732) 235-8113 or
by email (jacksofr@umdnj.edu).
Charges for these supplies will be distributed to the Department/Division/Unit
periodically. Supplies obtained by the Department on behalf of sites licensed
through the Department 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. A
procedure appropriate to the materials will be the responsibility of the site.
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.
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