CellNetix Surpasses CAP Expectations
By: Jeffrey Freed, M.D., Laboratory Director,Grays Harbor Community Hospital
The College of American Pathologists (CAP) is one of the “deemed” laboratory accreditation organizations and is a worldwide pathology society considered to be the leader in laboratory quality assurance. The accreditation process is done through unannounced biennial laboratory inspections and by performance of unknown test samples. The CAP’s accreditation process is comprehensive and stringent and covers all aspects of laboratory operations, including pre-test processes (such as specimen procurement and handling), analytic testing, and post-test processes (such as test reporting). The process also evaluates employee qualifications and competency testing results and corrective actions, continuing education records, the total quality management plan, and many other aspects of laboratory practice and operations.
While CAP’s approach to laboratory inspection and accreditation is comprehensive and stringent, it largely leaves the details of how to meet its intent to the discretion of the laboratory medical director. CellNetix goes above and beyond most laboratories in many ways. Whereas most laboratories use manual specimen tracking, CellNetix uses bar-coding to minimize operator error, to identify problems at the earliest possible time, and to minimize turnaround time. Whereas most laboratories review quality assurance data quarterly, CellNetix does so monthly. Whereas most laboratories internally review pathologists’ diagnoses in 3-10% of cases, and often after sign-out, CellNetix reviews 20% of cases prior to sign-out. Often the review is by a sub-specialty expert, and consultation is encouraged. All new cancer diagnoses are reviewed prior to sign-out. Every case that is reviewed at an outside institution is correlated with our diagnosis and reviewed in committee. This brief paragraph just scratches the surface of our comprehensive total quality management program.
In addition, CellNetix has a Standards Committee (staffed by sub-specialty experts) that continually tracks and updates our standard of care. All CellNetix pathologists enjoy a generous allowance for books, journal subscriptions, professional society dues, and meetings, and continuing medical education is evaluated by a committee for each pathologist, not just quantitatively but qualitatively. Constant dialogue with sub-specialty experts within the organization also helps to keep every pathologist current.
The federal government regulates quality standards for clinical laboratories that perform diagnostic testing on human specimens. The standards are given in the Clinical Laboratory Improvement Act (CLIA) of 1988 and are overseen by the Centers for Medicare and Medicaid Services (CMS) to ensure quality laboratory testing. For clinical laboratories to participate in the Medicare or Medicaid programs, the laboratories must be certified as complying with the conditions of participation, or standards, given in the CLIA regulations. The certification may be done by a state agency on behalf of CMS but may also be done by a national accreditation organization that enforces the standards in CLIA. Such organizations have “deemed status” that allows them to perform accreditation inspections in lieu of government inspections.
