Home >> ALL ISSUES >> 2016 Issues >> New tests, technologies at center of 2016 CAP checklist revamp

New tests, technologies at center of 2016 CAP checklist revamp

image_pdfCreate PDF

Anne Paxton

August 2016—Maybe laboratory accreditation checklists aren’t the first reading you reach for when you want to unwind. But for an intriguing window into laboratory medicine and how it’s changing, you might take a look at the revisions in the 2016 edition of the Laboratory Accreditation Program checklists, released in August.

“Just in the past few years, there’s been an explosion in the ways that pathologists and laboratory folks are using new technologies to serve patients in familiar ways,” says Gerald Hoeltge, MD, checklist commissioner and member of the CAP Council on Laboratory Accreditation. Many of the 2016 checklist revisions are geared to addressing this trend and related ones. Among the highlights: new standards for a just-emerging area of practice, a cogent recasting of one of the topics on which accreditation program staff field the most questions, revisions to keep pace with technology like mobile devices and robotic microscopy, and standards to catch up to the evolving role of telepathology.

Vocabulary updates, edits for concision and consistency, and streamlining are regular components of new checklist versions, and the 2016 checklist edition is no exception. For example, the word “documentation” has been changed to “records” throughout the checklists. But the 2016 checklists also feature notable additions and improvements to the requirements for record retention, in vivo microscopy, transfusion medicine, biorepositories, and telepathology. (For the 2016 revisions to the in situ hybridization checklist requirements, see page 60. The revisions to personnel checklist requirements will be covered next month.)

Record retention. The CAP had been receiving hints for some time that there was confusion about multiple different record retention requirements; accreditation program staff say they receive large numbers of questions on how long labs need to keep various types of records, Dr. Hoeltge notes. “These guidelines can apply to anything from tissue to cell samples to blood slides to plain old lab records,” says Checklists Committee chair William W. West, MD, “but we’ve found they are in various places, sometimes buried in the middle of a note underneath a checklist requirement.” They’re often buried in text as well. “There might be a long paragraph listing the retention requirements for various records,” says Dr. West, an associate professor and pathologist at the University of Nebraska Medical Center and Physicians Laboratory, PC, Omaha.

Dr. Hoeltge

Dr. Hoeltge

The Checklists Committee hopes confusion will be stemmed by the reformatted and condensed record retention requirements, now in four convenient tables: one in the general checklist (GEN.20377), one in surgical pathology (ANP.12500), one in autopsy (ANP.33500), and one in cytogenetics. Says Dr. Hoeltge: “The staff and the committee carefully went through all 21 checklists and found every area where there was some kind of a record retention requirement and put them all together into a format that’s easy to read and to identify whether your lab is utilizing best practices. The idea is that labs don’t have to search all those vast resources on the CAP website to find the guidelines.”

The tables will likely contain more detailed information in the future, and he considers the tabular format a model for future checklist reformatting of other types of requirements.

Some record retention requirements were also updated, Dr. West notes. “Minor adjustments were made in the terminology, and the potential for longer retention requirements for minors’ records was added.”

Transfusion medicine. The checklist changes in transfusion medicine are related to the May 23, 2016 FDA final rule (specifically, 21 CFR 606.145, “Control of Bacterial Contamination of Platelets”), says Yara A. Park, MD, chair of the CAP Transfusion Medicine Resource Committee. A full review of the transfusion medicine checklist is not scheduled until 2017. “But this round was the kind of review and revision we do of the checklist when new rules come from the FDA or new things come on the market.”

CAP TODAY
X