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Why has the CAP added a section on Physician Performed Testing (PPT)
to the Checklist? Inspecting this testing increases the amount of work we have
to do, and our physicians are upset about having their work addressed.
The CAP has added a specific PPT section because it has been difficult to locate
the Checklist questions that applied to this type of testing when they were
included in other sections of the Checklist. We believe that the addition of
this section should improve the inspection process. The PPT section does not
apply to all laboratories. For example, if a medical staff has its own PPM (Provider
Performed Microscopy) certificate, it will not be inspected as part of its institution’s
clinical laboratory, so the PPT section will not apply under these circumstances.
PPT applies only to a list of 14 tests, and only to physicians. If others such
as nurses perform any of these tests or physicians perform tests in addition
to these 14, the other sections of the Point of Care Checklist apply.
Is competency testing required for physicians who perform fecal occult
blood tests as part of their physical examinations?
The CAP does not require competency assessment of physicians who perform testing
that is within the scope of the practice of medicine as described in the Physician
Performed Testing (PPT) section of the POCT Checklist. Physician performed fecal
occult blood testing is among those tests that are included in the PPT section.
Under the most recent CAP POCT checklist, competency assessment of physicians
who perform PPT testing has been deemed part of the medical staff credentialing
process, and will no longer be included in CAP Point-of-Care inspections.
The CAP requires that all other healthcare providers, including nurse practitioners
and physicians’ assistants, undergo periodic competency assessments. Finally,
manufacturer quality control requirements and test instructions must always
be followed irrespective of who performs a test.
How should we assess the competency of physicians who perform POC testing?
Your institution, with the participation of the medical director, should establish
an institutional policy that addresses competency assessment for physicians
who perform point-of-care testing. For tests that are included in the physician
performed testing (PPT) section of the CAP POCT Checklist or are FDA classified
waived tests, oversight of physician competency is the responsibility of your
medical staff credentialing officials. Physician competency assessment for these
tests will not be addressed during CAP inspections. For POCT tests that are
not included within the Physician Performed Testing category and are FDA classified
moderate and high complexity tests, the requirements for physician training
and competency assessment will depend on the test under consideration. In some
circumstances, physicians may be required to demonstrate competency in the same
manner as other employees who perform these tests. Many institutions have outlined
specific tests that physicians are deemed competent to perform on the basis
of their training and educations. For those tests that have not already been
included in the PPT section of the Checklist, no additional documentation beyond
proof of completion of the requisite training is required.
Institutions have developed and implemented POCT training and competency programs
for physicians. The administration of these programs need not be the responsibility
of the point-of-care coordinator. Often the laboratory medical director or another
designated physician supervises POCT training and competency programs for physicians.
We have Hemoccult kits available for POCT testing in most of the units
at our facility. Physicians perform the occult blood testing. What are our laboratory’s
responsibilities for quality control testing?
Physician performed testing (PPT) is subject to CAP inspection only if the
laboratory director maintains overall responsibility for the testing.
Quality control must be documented for all tests that are subject to CAP inspection.
Each PPT site must maintain a technical procedure manual that includes specimen
handling information, and the laboratory must have documented evidence of an
effective quality improvement program that is appropriate for the nature of
the testing performed (in this case fecal occult blood testing). The quality
improvement program should at a minimum address daily quality control results,
instrument maintenance, and corrective actions for QC and/or reagent failure.
For tests that are included in the physician performed testing (PPT) section
of the CAP POCT Checklist or are FDA classified waived tests, oversight of physician
competency is the responsibility of your medical staff credentialing officials.
Physician competency assessment for these tests will not be addressed during
CAP inspections.
The Point-of-Care Testing Checklist requires that quality control be performed
and the results documented each day of patient testing. In order to verify that
a Hemoccult card is working properly, the performance indicator should be tested
for each card prior to reporting the patient result (refer to the manufacturer’s
product insert for specific testing instructions and recommendations). Physician
documentation of successful testing of the performance indicator can fulfill
the requirement for daily quality control, as testing personnel must perform
and record quality control results. Quality control results for PPT testing,
as with all POCT must also be reviewed by the medical director or his or her
designee, and there must be documentation of corrective action taken for any
unacceptable quality control results.
Our physicians perform occult blood and rapid urease testing (CLO tests)
during endoscopy procedures. Are we required to enroll in proficiency surveys
for these tests?
The CAP classifies occult blood and rapid urease testing that is performed
by physicians as part of their endoscopic examinations as Physician-Performed
Testing (PPT). This testing is subject to CAP inspection only if the testing
is performed under the laboratory’s CLIA certificate, or another CLIA
certificate that is subject to CAP inspection. The CAP does not require proficiency
testing for PPT, although such testing is subject to the requirements of the
PPT section of the CAP Point of Care Checklist.
Our physicians perform KOH and Wet Prep testing in our clinics and
in the hospital. Are they required to participate in proficiency surveys for
this testing? If physicians are the only persons who perform this testing, are
we required to maintain written procedures for it?
Procedure manuals and quality control are required for all tests that your
facility performs, even those that are performed solely by physicians. The CAP
does not require enrollment in proficiency surveys for PPT. However, because
there are no commercially available quality control materials for these two
tests, many laboratories use proficiency testing as a way to satisfy this CAP
requirement.
Physicians at our institution frequently perform bedside Hemoccult
testing. Do we need to document competency for these physicians? Must we document
quality control results for the testing that they perform?
For tests that are included in the physician performed testing (PPT) section
of the CAP POCT Checklist or are FDA classified waived tests, oversight of physician
competency is the responsibility of your medical staff credentialing officials.
Physician competency assessment for these tests will not be addressed during
CAP inspections.
Physicians must document quality control for the tests that they perform. Specifically,
in addition to patient results, daily positive and negative control results
should be recorded. A requirement for external controls depends upon the presence
of internal controls and manufacturer instructions. Please note that controls
must be run as often as the manufacturer requires, but no less frequently than
once each patient day. In the case of Hemoccult cards, for example, internal
positive and negative controls should be performed with each test card development.
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