NEW YORK (360Dx) – The new edition of the College of American Pathologists accreditation program checklists include a new section devoted to imaging mass spectrometry with 13 new requirements.
The imaging mass spectrometry requirements are among 40 new requirements to the 2018 accreditation checklists announced last month. The checklists, which provide medical laboratories with a blueprint for maintaining compliance with Centers for Medicare & Medicaid Services regulations, also included significant revisions to more than 240 requirements.
CAP noted that the imaging mass spectrometry section was being added because the organization views it as an emerging technology that is being increasingly used to provide molecular information on tissue specimen through visualization of the spatial distribution of proteins, lipids, and other molecules by their molecular masses. Imaging mass spec is used in conjunction with other pathology findings to make a tissue diagnosis.
CAP considers imaging mass spec to include whole-slide imaging, matrix-assisted laser desorption ionization mass spectrometry, individual molecular mapping of a tissue, and a data analysis process. The new requirements focus on these different methods and data analysis processes, according to William West, chair of the CAP Checklists Committee.
The requirements in the new section include procedures for the operation and calibration of the mass spectrometer, and requirements for maintaining records of appropriate maintenance and function checks for the instrumentation, according to West. There are also instrument calibration requirements, and requirements related to the use of appropriate control tissues each day of patient testing for the diagnostic state being considered. Other requirements relate to the use of appropriate reagents, solvents and consumables for the instrument and assay, and requirements related to validating the data analysis process, monitoring, recording, and upgrading data analysis procedures, and retaining appropriate data to support testing results or reanalysis if needed.
In total, CAP accreditation checklists include nearly 3,000 requirements organized into 21 checklists, which represent the CAP accreditation program's accreditation standards. During inspections, CAP teams use the checklists as a guide to assess overall management and operation.
Other notable changes to the checklists include a reorganization of analyte-specific reagent requirements related to laboratory-developed tests. Analyte-specific reagent requirements were removed from several discipline-specific checklists, such as cytogenetics, anatomic pathology, flow cytometry, microbiology and molecular pathology, according to West. Instead, the All Common Checklist on laboratory-developed tests was expanded to include information that is important for analyte-specific reagents.
This was done to reduce redundancy because the use of class I analyte-specific reagents makes a test a laboratory-developed test, with a few exceptions noted in the checklists, West explained. Since the All Common Checklist is used in conjunction with discipline-specific checklists, moving the requirements to the All Common Checklist only will help to "avoid cluttering up the patient report," he added. The change was made in response to questions from laboratories about the complexity of how the requirements were previously structured, he said.
In other areas, notable changes to checklists occurred in the areas of liquid nitrogen safety, forensic autopsy, cytology workload recording, and general laboratory requirements related to a policy on restricting laboratory access, according to a CAP spokesman.
CAP inspects CLIA laboratories through its Centers for Medicare & Medicaid Services-approved laboratory accreditation program. CMS requires CLIA certified labs to undergo an unannounced on-site inspection once every two years.