Originally published in CAP TODAY
In the new year, laboratories in the CAP's Laboratory Accreditation Program will be assessing their operations with new and updated checklist items addressing a range of topics. The revisions, part of the CAP's commitment to keep the checklists responsive to needs in the field, stem from comments by laboratory personnel and recommendations of various CAP committees.
Some of the changes, all of which went into effect
this fall, apply across the board. For example, each of the checklists
will have a new introductory section describing the credits that can be
earned by reviewing the online checklist CME/CE activity, says Karen Peterson,
MM, MLT(ASCP), MT(HEW), staff member of the Checklists Committee for the
Commission on Laboratory Accreditation. Beginning next month, CME/CE credit
can be earned by completing online inspection preparation activities (Related
article: CME/CE changes).
"We realized that each checklist could be used for
an effective CME/CE activity because it is like a textbook review of laboratory
medicine practice," Peterson says. "So now we have a system where you
can go onto the CAP Web site, sign up, and basically read the checklist,
complete the activity, and earn CME/CE credit."
Another addition to the checklists is a question about
whether the laboratory's current CAP activity menu accurately reflects
the tests performed. An accurate activity menu is required to properly
assess a laboratory's compliance with proficiency testing requirements.
The menu's accuracy can be assessed several ways, the checklists note:
by inquiry of responsible individuals or by examination of test requisitions,
computer order screens, procedure manuals, or patient reports.
Because interest in and use of telepathology is growing,
the Informatics Committee developed checklist requirements for telepathology
over the past year. "With digitalization of images, we all know remote
pathology is going to become more prevalent, so there are new phase II
requirements to ensure appropriate identification of slides and appropriate
security and confidentiality of patient information," says Stephen J.
Sarewitz, MD, chair of the CAP Checklists Committee.
Also included are phase I questions to ensure appropriate
training requirements for telepathology, and to ensure that the methods
and systems in place for telepathology are appropriate for the intended
clinical use. For example, if a dynamic telemicroscopy system is installed
on a microscope in the frozen section suite, the laboratory's procedure
manual might say the system is "intended for use in intraoperative consultations
and is not intended for second opinion consultation from pathologists
at outside institutions," the checklist notes.
In both the laboratory general checklist and the point-of-care
testing checklist, the competency requirement question has been modified.
Six elements of competency are listed. "Here we have revised the requirement
to say it may not be necessary to assess all six elements for each individual
on an annual basis," Peterson says. "It's up to the laboratory directors
to identify which elements are pertinent to the testing being performed."
In microbiology, the checklist changes are substantive,
Peterson says. "The Microbiology Resource Committee felt it was important
to add requirements for high-performance liquid chromatography."
Dr. Sarewitz says, "Since high-performance liquid chromatography
is now used to speciate organisms in mycobacteriology, it does come under
the microbiology discipline, so we added basic checklist questions on
calibration and quality control."
The new requirement in the flow cytometry checklist
is important because it addresses laboratories that perform only interpretation
of flow cytometry data—that is, the professional component. "These
laboratories refer flow specimens to outside laboratories for performance
of the technical component of testing, and the outside laboratory performing
the technical component is presumably participating in proficiency testing,"
Dr. Sarewitz says. "But there was no requirement that the referring laboratory
participate in a program to evaluate its performance in the interpretation
of flow data. Since an interlaboratory comparison program for interpretation
of flow data does exist, this question was added."
Another added item in flow cytometry is record retention.
Laboratories are now required to retain dot plots and histograms for 10
years. "There was no requirement previously," Peterson says.
In the cytopathology checklist, there are two new requirements
for fine-needle aspirations. Peterson says the first requirement concerns
placing patient identifiers on prepared slides and specimen containers
at the time of the procedure. The second asks, "If the pathologist performs
FNA procedures, is there a documented procedure to prevent errors in the
identification of the patient, the site, and the procedure?" The Joint
Commission Patient Safety Protocol is referenced in this checklist item.
There is also a modified item in the cytopathology
checklist, Dr. Sarewitz says. "This question formerly was: 'Is there a
mechanism to correlate the results of specialized studies (e.g. molecular
studies, immunocytochemistry) with the cytologic diagnosis?' That was
modeled after a similar checklist question in anatomic pathology."
"The problem with this was that in gynecologic cases
now, it's very common to do an HPV study along with a standard microscopic
gynecologic examination. So some laboratories were saying this will become
a monumental task in some situations to have to correlate an HPV result
with gynecology cases, although in other laboratories it's not a big issue."
Therefore, in the latest checklist edition, the question was restricted
to nongynecologic cytopathology only.
The hematology checklist is borrowing its new section
for semen analysis from the reproductive laboratory medicine checklist,
Dr. Sarewitz says. "The questions were kind of de-tuned to make them a
little less stringent and technical. But we felt if a laboratory is doing
semen analysis, it should follow more extensive requirements than were
in the previous edition."
In both the hematology and urinalysis checklists, a
new item ensures consistency among personnel for morphologic evaluations,
Peterson says. "We always had that requirement, but we added the proviso
that if there's a semiquantitative measurement, such as 1+, 2+, etc.,
then that needs to be evaluated." Dr. Sarewitz says generic terms were
used for years to describe how severe an abnormality is. "The additional
phrasing is simply that the laboratory procedures manual should define
what is meant by that," he says, "so all technologists can be on the same
page. It's very subjective, which is why each laboratory needs to establish
its own standard."
Some people have had trouble interpreting the revised
labeling requirements on the laboratory general checklist, he says. "There
are, one, patient identification requirements; two, requirements for primary
specimen containers; and three, requirements for secondary containers—for
example, used for aliquots, etc.—used in the laboratory. People
sometimes mix up these requirements."
"It's recommended, but not required, that primary sample
containers be labeled with two identifiers, except for blood bank samples
drawn for compatibility testing and for samples for reproductive labs.
Those are the only primary samples for which two identifiers are required.
For the secondary container, such as when you have an aliquot and make
a slide, there is no requirement for two identifiers. Patients, however,
must be identified with two identifiers prior to obtaining a specimen."
The transfusion medicine checklist's reorganized record
retention section now has a sleeker table format, provides more details,
and is clearer, making it easier to interpret, Peterson says. But the
chief change is the modified note for the question regarding a plan to
reduce the risk of mistransfusion.
Says Dr. Sarewitz: "This was actually new in the last
edition of the checklist; the Transfusion Medicine Resource Committee
separated that question from the monitoring requirement. In the course
of doing that, a phrase was put in the note saying a variety of systems
are acceptable but a second manual banding system was not acceptable."
To some participants, this was cause for concern. "There
are a number of certainly very fine and reputable transfusion services
that were saying, 'We use a second manual banding system and it works
for us.' Or 'We don't have the resources to put in a barrier or electronic
method.' So it was changed to say a second manual banding system is acceptable
but it's not as good as an electronic or barrier system."
In the future, the CAP would like to move laboratories
more toward electronic methods, Dr. Sarewitz says, pointing to a similar
trend in identification for administering drugs in hospitals.
A new question on transfusion-related acute lung injury
was added to the transfusion medicine checklist in response to TRALI's
emergence as the leading cause of post-transfusion morbidity and mortality,
Dr. Sarewitz notes. "It's important for laboratories to get a handle on
that and determine how often it's occurring in their setting."
Anne Paxton is a writer in Seattle. For a complete
set of the revised LAP checklists, log on to www.cap.org.