Laboratorio Clinico Acropolis

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records review ( 2019-2020) and laboratory general supervisor interview on October 16, 2020 at 9:10 A.M., it was determined that the laboratory failed to participate in the Hematology third testing event performed in November 2019. The findings include: 1. Puerto Rico Proficiency Testing Program records were review from year 2019 to 2020. 2. The records showed that the laboratory did not participate in the third testing event of hematology ( November 2019) established by the Proficiency Testing Program. 3. The laboratory general supervisor confirmed on October 16, 2020 at 9:10 A.M., that the laboratory failed to participate in the third testing event of hematology specialty in November 2019. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. 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 -- This STANDARD is not met as evidenced by: Based on facility records review ( 2019-2020 ) and laboratory general supervisor interview at 9:45 AM on October 16, 2020, it was determined that the laboratory failed to be in compliance with the Puerto Rico State laboratory regulation. The findings include: 1. The laboratory Biomedical Generator Number ( DBR-RA-47-14- 02-0089 ) was due since December 18,2019. 2. The laboratory owner confirmed on October 16, 2020 at 10:30 A.M.01/13/2016, that the Biomedical Generator Number was due since December 18, 2019 and the laboratory renew the new Biomedical Generator Number on September 2020. 3. The state law establishes that the Biomedical Generator Number must be renew 60 days before the expired date. D6084 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on facility records review (from 2019-2020) and laboratory general supervisor interview on October 16, 2020 at 10:30 A.M., it was determined that the laboratory director failed to be in compliance with the Puerto Rico State laboratory regulation. The finding includes: 1. The laboratory Biomedical Generator Number was due since December 18, 2019 and renew on September 2020. Refer to D3009. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency testing records review (2019-2020) and laboratory general supervisor interview on October 16, 2020 at 9:10A.M. it was determined that the laboratory failed to ensure that proficiency testing samples were tested as required under Subpart H requirements. The finding includes: 1. The laboratory failed to participate in the Hematology third testing event performed in November 2019. Refer to D2023. -- 2 of 2 --

Summary Statement of Deficiencies D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records review ( 2016 to 2018) and laboratory general supervisor interview on May 16, 2018 at 11:000 A.M., it was determined that the laboratory failed to report the proficiency testing results within the time frame established by the program. The findings include: 1. Proficiency testing records were reviewed from February 2016 to February 2018. 2. The deadline of the second testing event report of hematology tests was July 29, 2016. 3. The laboratory did not report the second testing event of hematology ( cell identification and sedimentation rate test) within the time frame established by the Proficiency Testing Program. 4. The laboratory general supervisor confirmed on May 16, 2018 at 11:30 A. M. , that the laboratory did not report the hematology testing results of the second testing event within the time frame established by the Proficiency Testing Program. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program records review ( 2016 to 2018) and laboratory general supervisor interview on May 18, 2018 at 10:30 A.M., it was determined that the laboratory failed to verify the accuracy of the hematology cell identification and sedimentation rate test that received a zero score for nonparticipation. The findings include: 1. Proficiency testing records were reviewed from February 2016 to February 2018. 2. The deadline of the second testing event report of hematology tests was July 29, 2016. 3. The proficiency testing records showed that the laboratory did not verify the accuracy of the hematology cell identification and sedimentation rate tests that received a zero score for nonparticipation in July 2016. 4. The general supervisor stated on May 16, 2018 at 11: 00 A.M. that the laboratory did not have a mechanism to verify the accuracy of the hematology cell identification and sedimentation rate tests that received a zero score for nonparticipation on July 2016. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of