Q&A with Su-Chieh Pamela Sun, MPA, MT(ASCP)
System Administrative Director, Laboratory Services
CarePoint Health System
MedicalLab Management: With what frequency does the College of American Pathologists (CAP) inspect clinical laboratories?
Pam Sun: As both a laboratory administrative director and voluntary inspector for CAP, I am able to see both sides of the process. Laboratories are able to prepare for a routine CAP inspection like an open book test, which is to know your biennial inspection window, and ensure practice adherence to the Laboratory General Checklist, All Common Checklist, and the individual disciplines’ checklists (eg, Immunology, Hematology, Chemistry, etc). Reaccreditation inspections take place every two years, and although the lab is well aware of a general inspection period, CAP inspectors can show up, unannounced, up to three months prior to the anniversary date of the last inspection.
There are additional triggers for CAP inspections that laboratories can go through. Obviously there is the initial, scheduled inspection when a facility first seeks accreditation by CAP. If the laboratory successfully obtains the accreditation, the initial inspection date becomes the basis for the future biennial inspection schedule. Beyond the routine inspections, CAP may perform an inspection if a complaint is made. Furthermore, because CAP is performing its functions as an approved accreditation organization with deeming authority under CLIA, (as do other accrediting bodies, such as COLA), CMS also performs their own validation inspections on a percentage of laboratories independent of CAP.
MLM: How should the laboratory director and individual department heads approach the CAP checklists?
Sun: Every laboratory discipline receives its own technical checklist customized for their activity test menu. In addition, the All Common Checklist applies to all laboratory subsections. The laboratory director is responsible for ensuring all the checklists are accounted for as the many of the elements in individual checklists feed into the requirements in Lab General.
A good example is monitoring and recording temperatures, which is covered in technical, All Common, and Lab General checklists (eg, HEM.37200, COM.30750 and GEN.41042). Keep in mind all the disciplines of a clinical laboratory that rely on temperature control—blood bank, hematology, coagulation, immunology, chemistry, etc; the types of products that require temperature control—reagents, specimens, etc; the instruments that require testing to be performed within certain temperature parameters; and the devices that control temperature—refrigerators and freezers, blood transport containers, warming baths, storage rooms, etc. While some facilities have system-wide, all encompassing automated temperature monitoring systems in place, many facilities do not, or are able to automate certain systems, but not others. Thus, ensuring all areas are complying with a common or related standard is important as one finding could result in multiple deficiencies.
MLM: What advice would you give laboratory directors about approaching CAP inspections?
Sun: Ultimately, the word ‘inspection’ can have a somewhat negative connotation that is inevitably applied to this process. While having your operations evaluated by a peer group can be anxiety producing, the point is not to “pass” an inspection; rather, the goal of accreditation from an organization like CAP is to ensure the safety and reliability of patient care. The processes that are reviewed have direct, downstream influence on quality of care and patient safety. For instance, going back to the example of proper temperature monitoring, if a blood unit is spoiled during transport due to a failure to properly store or monitor the temperature of that unit, patient safety can be compromised.
Health care being one of the most highly regulated industries, inspection is just part of the business. I appreciate that the unexpected nature of the process is unsettling. That said, if the laboratory is performing at a high level with quality, efficiency, and patient safety as its governing principles and with written policies and procedures that describe those practices, then they are already taking the initial steps in what is necessary to comply with accrediting agency standards and should embrace the affirmations and recommendations they provide.
Su-Chieh Pamela Sun, MPA, MT(ASCP), is system administrative director, laboratory services at CarePoint Health System in Jersey City, New Jersey. Pam is a voluntary laboratory inspector for CAP.
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