Lab Clin Referencia Cima

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Referencia CIMA on December 17, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. During a recertification survey on December 17, 2025, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1208 Condition: Bacteriology 42 CFR 493.1441 Condition: Laboratory Director D2025 BACTERIOLOGY CFR(s): 493.823(c) (c) 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 review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025), CASPER Report 0155D, Proficiency Testing Service Program 2024 Schedule, and laboratory general supervisor interview on December 17, 2025, at 10:00 A.M., it was determined that the laboratory failed to report to the PRPTSP, the bacteriology proficiency testing results within the timeframe established by the proficiency testing program. The laboratory processed and reported 1,998 out of 1,998 bacteriology patient tests from September 2024 to April 2025. The findings include: 1. The PRPTSP and CASPER report were reviewed on December 17, 2025, at 10:00 A.M., from February 2024 to December 2025. 2. The Proficiency Testing Service Program 2024 schedule showed that the deadline for submission of results for the third testing event for Microbiology was December 20, 2024. 3. The laboratory obtained a score of 0% for the third testing event for gram stain, bacteriology identification and bacteriology antimicrobial susceptibility. 4. During interview on December 17, 2025, at 10:15 A.M., the laboratory general supervisor confirmed that the laboratory failed to report bacteriology proficiency testing results for the third Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- testing event within the timeframe established by the PRPTSP. 5. The laboratory processed and reported 1,998 out of 1,998 bacteriology patient tests from September 2024 to April 2025. D2052 PARASITOLOGY CFR(s): 493.829(c) (c) 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 review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025), CASPER Report 0155D, Proficiency Testing Service Program 2024 Schedule, and laboratory general supervisor interview on December 17, 2025, at 10:00 A.M., it was determined that the laboratory failed to report to the PRPTSP, the parasitology proficiency testing results within the timeframe established by the proficiency testing program. The laboratory processed and reported 106 out of 106 parasitology patient tests from September 2024 to April 2025. The findings include: 1. The PRPTSP and CASPER report were reviewed on December 17, 2025, at 10:00 A.M., from February 2024 to December 2025. 2. The Proficiency Testing Service Program 2024 schedule showed that the deadline for submission of results for the third testing event for Microbiology was December 20, 2024. 3. The laboratory obtained a score of 0% for the third testing event for identification of parasitology. 4. During interview on December 17, 2025, at 10:15 A.M., the laboratory general supervisor confirmed that the laboratory failed to report parasitology proficiency testing results for the third testing event within the timeframe established by the PRPTSP. 5. The laboratory processed and reported 106 out of 106 parasitology patient tests from September 2024 to April 2025. D2071 SYPHILIS SEROLOGY CFR(s): 493.835(c) (c) 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 review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025), CASPER Report 0155D, Proficiency Testing Service Program 2024 Schedule, and laboratory general supervisor interview on December 17, 2025, at 10:00 A.M., it was determined that the laboratory failed to report to the PRPTSP, the syphilis serology proficiency testing results within the timeframe established by the proficiency testing program. The laboratory processed and reported 1,004 out of 1,004 syphilis serology patient tests from September 2024 to April 2025. The findings include: 1. The PRPTSP and CASPER report were reviewed on December 17, 2025, at 10:00 A.M., from February 2024 to December 2025. 2. The Proficiency Testing Service Program 2024 schedule showed that the deadline for submission of results for the third testing event for Diagnostic Immunology was December 20, 2024. 3. The laboratory obtained a score of 0% for the third testing event for syphilis serology. 4. During interview on December 17, 2025, at 10:15 A. -- 2 of 5 -- M., the laboratory general supervisor confirmed that the laboratory failed to report syphilis serology proficiency testing results for the third testing event within the timeframe established by the PRPTSP. 5. The laboratory processed and reported 1,004 out of 1,004 syphilis serology patient tests from September 2024 to April 2025. D2081 GENERAL IMMUNOLOGY CFR(s): 493.837(d) (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 review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025), CASPER Report 0155D, Proficiency Testing Service Program 2024 Schedule, and laboratory general supervisor interview on December 17, 2025, at 10:00 A.M., it was determined that the laboratory failed to report to the PRPTSP, the general immunology proficiency testing results within the timeframe established by the proficiency testing program. The laboratory processed and reported 187 out of 187 general immunology patient tests from September 2024 to April 2025. The findings include: 1. The PRPTSP and CASPER report were reviewed on December 17, 2025, at 10:00 A.M., from February 2024 to December 2025. 2. The Proficiency Testing Service Program 2024 schedule showed that the deadline for submission of results for the third testing event for Diagnostic Immunology was December 20, 2024. 3. The laboratory obtained a score of 0% for the third testing event for immunoglobulins IgE, Infectious Mononucleosis, Rheumatoid Factor and Rubella. 4. During interview on December 17, 2025, at 10:15 A.M., the laboratory general supervisor confirmed that the laboratory failed to report general immunology proficiency testing results for the third testing event within the timeframe established by the PRPTSP. 5. The laboratory processed and reported 187 out of 187 general immunology patient tests from September 2024 to April 2025. . D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Bacteriology quality control records review (years 2024-2025) and interview with the laboratory general supervisor on December 17, 2025, at 2:30 P.M., it was determined that the laboratory failed to ensure compliance with the analytic system requirements for Bacteriology testing. Refer to D5507. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests -- 3 of 5 -- are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on Bacteriology quality control (QC) records review (years 2024-2025), the establishment and verification of performance specification, and interviews with the laboratory general supervisor on December 17, 2025, at 11:30 A.M., it was determined that the laboratory did not include a negative control material each day of patient testing for antimicrobial susceptibility testing. The laboratory performance the quality control procedure on a weekly basis. The laboratory processed and reported 107 out of 107 antimicrobial susceptibility testing from June 18, 2025, to December 16, 2025. The findings include: 1. The laboratory uses the VITEK 2 system to perform organism identification and antimicrobial susceptibility testing. 2. The laboratory evaluated and verified the performance specifications for the AST panel XN-806 on October 8, 2024, through January 11, 2025. 3. The review of quality control records showed that the laboratory performed antimicrobial susceptibility quality control testing weekly. 4. The laboratory processed and reported 107 out of 107 patient samples with the AST panel XN-806 from June 18, 2025, to December 16, 2025. 5. During interview on December 17, 2025, 2025, at 11:45 A.M., the laboratory general supervisor confirmed that the laboratory did not include a negative control material for antimicrobial susceptibility testing quality control, each day of use. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on Bacteriology quality control records review (years 2024-2025) and interview with the laboratory general supervisor on December 17, 2025, at 2:30 P.M., it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D6093. D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) (e)(4)(ii) The results are returned within the timeframes established by the proficiency testing program; This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025), CASPER Report 0155D, Proficiency Testing Service Program 2024 Schedule and laboratory general supervisor interview on December 17, -- 4 of 5 -- 2025, at 10:25 A.M, it was determined that the laboratory director failed to ensure that the laboratory general supervisor submitted proficiency testing results for Microbiology (Bacteriology and Parasitology) and Diagnostic Immunology (Syphilis Serology and General Immunology) within the timeframe established by the proficiency testing program. Refer to: D2025, D2052, D2071 and D2081. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment 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: Based on quality control records review (years 2024-2025) and interview with laboratory general supervisor on December 17, 2025, at 2:30 P.M., it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the Bacteriology quality control requirements. Refer to D6117. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on Bacteriology quality control records review (years 2024-2025) and interview with the laboratory general supervisor on December 17, 2025, at 2:30 P.M., it was determined that the laboratory technical supervisor did not ensure that antimicrobial susceptibility quality control procedures were performed each day of testing when the laboratory began with the new antimicrobial susceptibility panel. Refer to D5507. -- 5 of 5 --

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on hematology quality control records review (years 2018-2019) and laboratory general supervisor interview on December 26, 2019 at 11:00 AM, it was determined that the laboratory failed to meet the analytic system requirements for Hematology specialty (sperm cell counts). Refer to D 5543 (the laboratory failed to include one control material each 8 hours of operation when manual sperm cell counts were performed by hemocytometer). D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on sperm count testing records review (years 2018-2019), lack of quality control records and laboratory general supervisor interview on December 26, 2019 at 11:00 AM., it was determined that the laboratory failed to include one control material each 8 hours of operation when manual sperm cell counts were performed by hemocytometer. The findings include: 1. The records showed that the laboratory 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 -- performed manual cell counts (sperm cell count) by the hemocytometer. 2. From January 2018 to December 25, 2019, the records showed that the laboratory did not include one control material each 8 hours of operation when 27 out 27 patients specimens were processed for sperm cells counts by the hemocytometer. 3. The laboratory processed and reported twenty seven sperm count patient's samples from January 2018 to December 25, 2019. (2018 = 15, 2019 = 12). 4. The laboratory general supervisor confirmed on December 26, 2019, that the testing record not show any documentation of the control procedure. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on hematology quality control records review and laboratory general supervisor interview on December 26, 2019 at 11:00 AM , it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D 6093. 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: Based on hematology quality control records review (years 2018-2019) and laboratory general supervisor interview on December 26, 2019 at 11:00 AM , it was found that the laboratory director did not assure that the quality control procedures related to sperm cells counts were followed. Refer to D 5543. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on hematology quality control records review(years 2018-2019) and laboratory general supervisor interview on December 26, 2019 at 11:00 AM , it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. Refer to D6177. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) -- 2 of 3 -- Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on hematology quality control records review (years 2018-2019) and laboratory general supervisor interview on December 26, 2019 at 11:00 AM , it was determined that testing personnel failed to follow quality control procedures. The finding includes: 1. The laboratory failed to include one control material each 8 hours of operation when manual sperm cell counts were performed by hemocytometer. The laboratory processed and reported twenty seven (27) sperm count patient's samples from January 2018 to December 25, 2019. (2018 = 15, 2019 = 12). -- 3 of 3 --

Summary Statement of Deficiencies D2082 GENERAL IMMUNOLOGY CFR(s): 493.837(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 (PRPTP) records review and laboratory general supervisor interview on January 19, 2018 at 9:15 AM, it was determined that the laboratory failed to take and document