Checklists 2015: signposts are clarity, consistency

Anne Paxton

August 2015—It doesn’t come swathed in a ribbon on the showroom floor, but the 2015 edition of the CAP Laboratory Accreditation Program checklists is new, improved in style and substance, and ready to roll. More precise and consistent quality terminology, more consolidation of requirements into the All Common checklist, and increased clarity on how labs can demonstrate their level of quality are among the highlights of the 2015 edition.

The most noteworthy changes relate to quality terminology, personnel records, specimen labeling, laboratory-developed tests, cancer protocols, and next-generation sequencing. (See page 62 for comments on the next-generation sequencing checklist revisions, and the July issue for details on new Individual Quality Control Plan requirements. A new checklist section on in vivo microscopy, which has been added to the anatomic pathology checklist, will be the subject of a CAP TODAY story in an upcoming issue.)

The broadest changes this year involve quality terminology, says Gerald Hoeltge, MD, checklist commissioner and a member of the Checklists Committee. These revisions are a work in progress, but in this round they led to hundreds of changes in wording to make the use of important terms more precise and more consistent, to reduce redundancy, and to improve concordance with International Standards Organization (ISO) terminology.

“There were a couple of motivations behind the quality terminology changes,” Dr. Hoeltge says. “First is the fact that quality is consistency. We’ve got 21 different checklists and sometimes, not surprisingly, words have different shades of meaning in different locations of the checklist. Any word that appears in the checklists ought to be used the same way wherever it appears.”

“Second, we know that English is not the first language for many of the participants in the accreditation program. So we’ve added a long list of definitions to the checklist.”

The Checklists Committee edited three of every five checklist requirements this year with the quality terminology project in mind, so 60 percent of the requirements had some changes in them as a result, Dr. Hoeltge says. But the quality terminology project has not changed the meaning of any checklist requirement. “We hope it has made them all a little clearer,” he says.

“Terms like ‘procedure,’ ‘policy,’ ‘document,’ ‘preventive action,’ and ‘corrective action’ are used by the Clinical and Laboratory Standards Institute and international standards groups in a very specific way,” says William W. West, MD, chair of the Checklists Committee. “These are common terms in technical manuals and other laboratory publications. When we looked across the checklists, the terms were generally used properly but there was some variation within and between checklists. For example, in the 21 checklists, we found that each would use the term ‘process’ a little differently, sometimes even within the same checklist.”

“We were trying to standardize use of the terms so that no matter which checklist you pick up, the term will be used the same way and have the same meaning.”

The revisions mean that the word “policy” is sometimes replaced with “procedure,” while the word “documented” may be replaced with “recorded.” For example, the mandate “Data must be documented” becomes “Data must be recorded.”

Other changes standardize use of terms with subtly different meaning, such as “preventive action” and “corrective action.”

“Preventive action is defined as action to eliminate the cause of a potential non-conformity or any other undesirable potential situation,” Dr. West says, “while corrective action is action to eliminate the cause of a detected non-conformity or other undesirable situation. We used these terms interchangeably at one time, but they mean different things.”

Inconsistencies may seem minor and minimally perceptible to an end user, but they can compound and lead to confusion, he says. “As we start to move into international markets—a growing segment of our accredited laboratories—it becomes even more difficult for international users to understand why we would use the same terminology in different ways in different checklists.” Getting terminology in line with standards like ISO 15189 is a benefit of standardizing quality terminology, “so we’re all speaking the same language, so to speak.”

In a major move toward increased consistency, the 2015 checklists now describe specimen labeling requirements as part of the All Common checklist. “Specimen labeling was described in each of the specialty checklists before, so there were almost 40 ways it was referred to,” Dr. Hoeltge says. “Moving it into the All Common checklist obviously reduces the number of requirements for special labeling, and makes the requirements exactly the same now in every part of the laboratory.”

A handful of areas like transfusion medicine do have additional issues in specimen labeling and some requirements remain in those specialty checklists. “But the heavy lifting now is really done with just the All Common checklist requirements.”

A key issue in standardizing specimen labeling (in COM.06100 and COM.06200) was defining the concept of a primary and a secondary specimen. With the 2015 checklists, a primary specimen is defined as the body fluid, tissue, or sample submitted for examination, study, or analysis and that may be within a collection tube, cup, syringe, swab, slide, data file, or other form as received by the laboratory. “A primary label is the label that’s on the specimen when it arrives in the laboratory, so it has requirements for unequivocal identification of contents,” Dr. Hoeltge explains.

The secondary specimen is any derivative of the primary specimen used in subsequent phases of testing, he says. “So it may be an aliquot, dilution tube, slide, block, culture plate, reaction unit, data extract file, image, or other form during the processing or the testing of the specimen.” The aliquots or images created by automated devices and tracked by internal electronic means are not secondary specimens, he notes.

Taking an aliquot as an example, “we have a primary specimen that comes into the lab and we’re going to do some chemistry on it, some hematology on it, and some microbiology on it,” Dr. Hoeltge says. “So that primary specimen is now divided into three secondary specimens. The accession part of the lab will be really focused on COM.06100, the primary specimen labeling requirement. But the other parts of the lab will be getting secondary specimens, so they will be more interested in the COM.06200 part of the requirement.”

The newly formulated definitions are helpful for laboratories with less common specimen types too, Dr. Hoeltge notes. For laboratories doing next-generation sequencing, for instance, “a primary specimen can be a data file. We have some bioinformatics laboratories in the program that are bioinformatics only. They don’t do any wet testing at all; the data file is their primary specimen.”

In the new labeling requirements, the primary container is basically the innermost container that holds the patient specimen, Dr. West says. “So you have to have two unique ways of identifying that specimen; there have to be two patient-specific identifiers. The secondary specimen containers, on the other hand, just have to have one identifier, but it has to be traceable back to all the information associated with the primary specimen.”

The specimen labeling changes continue the Checklists Committee’s efforts to move as much as possible of the specialty checklists into the All Common checklist. Eventually the committee would like to have the All Common requirements and a specialty’s requirements in a single checklist for that particular section of the lab, “with the added value that those All Common requirements will look identical, whether it is a hematology lab, a chemistry lab, or any other part of the laboratory,” Dr. Hoeltge says.

Addressing one of the most common concerns about how to comply with checklist requirements on personnel records, the 2015 edition revises the Laboratory General checklist item GEN.54400 to allow labs to use a certification verification organization (CVO) to confirm personnel qualifications to perform lab testing.
The difficulty of maintaining current personnel qualifications on file—especially for large organizations with hundreds of laboratory testing personnel, such as nurses, who perform nonwaived testing—has been a chronic source of complaints by laboratories, which have been required to produce personnel documentation for inspectors on the day of inspection.

Based on these comments, the CAP is now requiring that if a laboratory uses a CVO, instead of being required to obtain paper copies of diplomas and transcripts for all personnel, the laboratory will have seven days to obtain a copy of the diploma or transcript upon request. GEN.54400 will require laboratories using a CVO to perform an initial validation of the effectiveness of the process and an annual audit to confirm that the process continues to be reliable.