Laboratorio Clinico Avanzado Emmanuel Inc

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 culture media record review, patient worksheet records and interview with the laboratory general supervisor and laboratory technical supervisor on July 6, 2023 at 9:20 AM; it was determined that the laboratory performed seven (7) out of seven (7) culture with a Blood Agar media that exceeded the expiration date from May 11, 2022 to May 13, 2022. The findings include: 1. The laboratory perform growth or no growth of urine culture in the Bacteriology specialty. 2. On July 6, 2023 at 9:05 AM the record of culture media was reviewed. The record culture media showed one batch of Blood Agar media (Lot # 452735) with an expiration date of May 10, 2022. Another batch of Blood Agar media (Lot# 471815) with an expiration date of June 14, 2022 was received on May 13, 2022. 3. On July 6, 2023 at 9:11 AM the patient worksheet record was reviewed from May 11, 2022 to May 13, 2022 and showed that the laboratory used the Blood Agar media that exceeded the expiration date from May 11, 2022 to May 13, 2022 in seven (7) patients. 4. On July 6, 2023 at 9:20 AM the laboratory general supervisor and laboratory technical supervisor confirmed that the laboratory used a expired culture media to perform and process a urine culture for seven (7) out of seven (7) patients. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established 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 -- 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: Based on Bacteriology specialty culture of media records review (year 2022), patients worksheet record review and interview with the laboratory general supervisor and laboratory technical supervisor on July 6, 2023 at 9:20 AM; it was determined that the laboratory director failed to ensure that the culture media not exceed the expiration date and that the laboratory were in compliance. Refer to D5417. -- 2 of 2 --

Summary Statement of Deficiencies D2128 HEMATOLOGY CFR(s): 493.851(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 Program records reviewed ( year 2017- 2019 ) and laboratory director interview on May 17, 2019 at 9:30 A.M., it was determined that the laboratory failed to take and document