Laboratorio Clinico Jardines Corp

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on Immunohematology control records review and laboratory general supervisor interview on October 22, 2021 at 10: 18 AM. , It was determined that the laboratory used Screeming Cells I, Screening Cells II and Coombs Control Cells, controls materials that have exceeded their expiration date. The findings include: 1. Review of Immunohematology quality control records showed that laboratory used Screening Cells I (lot: S254 exp march 30, 2021), The Screening Cells II (lot: S254 exp march 30, 2021), Coombs Control Cells (lot: K713 exp. march 30,2021) from March 31, 2021 to April 7, 2021. 3. From March 31, 2021 to April 7, 2021 the laboratory processed and reported five patient samples. 4. The laboratory supervisor confirmed on October 22, 2021 at 10:18 AM that the laboratory used expired control material and they tested and reported five out of five patient samples. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on Immunohematology quality control records review and laboratory director interview on October 22, 2021 at 10:18 AM, it was determined that the laboratory director failed to comply with the analytic system requirements. Refer D 5417. -- 2 of 2 --

Summary Statement of Deficiencies 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 P.R.Proficiency Testing Program (PRPTP) records review and laboratory general supervisor interview on August 30, 2019 at 8:20 AM, it was determined that the laboratory failed to take and document