Clickable credit, competency, more
  In checklists, changes of all shapes and sizes

December 2007
Originally published in CAP TODAY

Anne Paxton

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."

Related Links

• CME/CE changes
• Team member training requirement kicks in Dec. 31