Summary:
Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at CLINICA TODO SALUD-LABORATORIO CLINICO on July 11, 2024. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following condition level deficiencies were found during the unannounced routine CLIA recertification survey ending on July 11, 2024. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing events review, proficiency testing written manual and laboratory general supervisor interview on July 11, 2024 at 9:15 A.M., it was determined that the laboratory failed to take and document