Centro De Diagnostico Y Tratamiento De

Summary Statement of Deficiencies D0000 An offsite Proficiency Test (PT) Desk Review was performed on October 16, 2025 to Laboratorio Clinico Centro de Diagnstico y Tratamiento Villa Los Santos, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1441 Laboratory Director, High complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Certification And Survey Provider Enhanced Reports (CASPER) 0155D and Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (year 2025), the laboratory failed to achieve satisfactory performance (80% or 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 -- better) for two (2) out of two (2) consecutive testing events for the specialty of hematology in the analyte Hematocrit (HCT) tests. Refer D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER Report 0155D and PRPTSP scores (year 2025), the laboratory failed to achieve satisfactory performance (80% or better) for two (2) of two (2) consecutive testing events in a proficiency testing program approved by HHS, for hematology specialty for analyte Hematocrit (HCT) tests. The findings include: 1. Review of the Casper Report 0155D and PRPTSP scores on September 30, 2025, confirmed that the laboratory had a PT failure for the analyte Hematocrit (HCT) tests. The laboratory obtained the following testing scores: Analyte: Hematocrit (HCT) a. First testing event year 2025 - 40% b. Second testing event year 2025 - 60% 2. A review of the PRPTSP records confirmed the above findings. 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 review of the CASPER Report 0155D and PRPTSP scores (year 2025), the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0155D and PRPTSP scores (year 2025), the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program.. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D2093 ROUTINE CHEMISTRY CFR(s): 493.841(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 reviewed ( 2022-2023) and laboratory director interview on December 6, 2023 at 9:30 A.M., it was determined that the laboratory failed to report the routine chemistry and urinalysis proficiency testing results within the time frame established by the program. The findings include: 1. Proficiency testing records were reviewed on December 6, 2023 at 9:30 A.M. from February 2022 to November 2023. 2. The deadline of the second testing event report of routine chemistry and urinalisys was May 20, 2022. ( review at 9:40 A,M.) 3. The laboratory director confirmed on December 6, 2023 at 9:45 A.M. that the laboratory failed to report the routine chemistry and urinalysis proficiency testing results of the second testing event within the time frame established by the Proficiency Testing Program. D2104 ENDOCRINOLOGY CFR(s): 493.843(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 reviewed ( 2022-2023) 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 -- and laboratory director interview on December 6, 2023 at 9:30 A.M., it was determined that the laboratory failed to report the endocrinology proficiency testing results within the time frame established by the program. The findings include: 1. Proficiency testing records were reviewed on December 6, 2023 at 9:30 A.M. from February 2022 to November 2023. 2. The deadline of the second testing event report of endocrinology was May 20, 2022. ( review at 9:40 A,M.) 3. The laboratory director confirmed on December 6, 2023 at 9:45 A.M.that the laboratory failed to report the endocrinology proficiency testing results of the second testing event within the time frame established by the Proficiency Testing Program. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on Immuno Card Mycoplasma manufacturer's instructions, General Immunology (Mycoplasma pneumoniae) testing record review since January 2022 and interview with the laboratory director on December 6, 2023 at 12:45 PM, it was determined that the laboratory failed to follow the manufacturer's instruction when 2, 198 out of 2,198 patients specimens were tested and reported for of Mycoplasma pneumoniae since January 2022. The findings include: 1. The laboratory use the Immuno Card Mycoplasma Test to perform the Mycoplasma pneumoniae qualitative tests. 2. The manufacturer's instruction establishes to perform the test procedures at room temperature range from 22 to 25 C. ( review on December 6, 2023 at 12:40 PM ) 3. On December 6, 2023 at 12:40 PM, review of the Mycoplasma pneumoniae testing records showed that the laboratory did not monitor nor document the room temperature when patient's specimens were tested for Mycoplasma by Immuno Card Meridian method. 4. The laboratory director confirmed on December 6, 2023 at 12:45 PM, that the laboratory did not monitor nor document the room temperature when it processed the patients specimens for Mycoplasma pneumoniae test. 5. The laboratory processed and reported 2,198 out of 2,198 patient samples for Mycoplasma pneumoniae test since January 2022. 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 Program testing records review ( 2022-2023 ) and laboratory director interview on December 6, 2023 at 9:50 A.M., it was determined that the laboratory director failed to ensure that proficiency testing samples were tested as required under Subpart H requirements. Refer to D2093 and D2104. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) -- 2 of 3 -- 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 Mycoplasma pneumonia IgM manufacturer's instructions review and interview with the laboratory director on December 6, 2023 at 12:45 P.M, it was determined that the laboratory director failed to follow the manufacturer's instruction when 2, 198 out of 2,198 patients specimens were tested and reported for of Mycoplasma pneumoniae since January 2022. Refer to D5405. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(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 review of Mycoplasma pneumonia manufacturer's instructions and interview with the laboratory director on December 6, 2023 ar 12:45 P.M, it was determined that the testing personnel did not follow manufacturer's instructions for Mycoplasma pneumonia temperatures requirements. Refer to D5405. -- 3 of 3 --

Summary Statement of Deficiencies D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Mycoplasma pneumoniae quality control records patient records review ( 2020-2021 ) and interview with the laboratory director on December 2, 2021 at 12:00 P.M., it was determined that the laboratory failed to meet the requirements in the subspecialty of General Immunology. The finding includes: a. The laboratory did not include an external positive and a negative control material each day of patient testing. Refer to : 5449- The laboratory did not include positive and negative control material D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on General Immunology ( Mycoplasma Pneumoniae test ) quality control records review ( 2020-2021 ) and interview with the laboratory director on December 2, 2021 at 12:00 PM , it was determined that the laboratory failed to include a 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 -- negative and positive control material when performed Mycoplasma Pneumoniae test by Immuno Card method. The findings include : a. The laboratory performed Mycoplasma Pneumoniae test by Immuno Card method. b. Mycoplasma quality control logs were reviewed from 2020 to December 2021. c. The records showed that the laboratory did not include a negative and positive control material from April 20, 2021 to December 2, 2021. The laboratory performed and reported 3,970 mycoplasma patient samples in 2020 and 944 in 2021. d. The laboratory director confirmed on December 2, 2021 at 12:00 P. M., that the laboratory failed to include a negative and positive control material each day of testing when performed Mycoplasma Pneumoniae test by Immuno Card method. 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 quality control records review ( 2020-2021 ) and laboratory director interview at 12:30 p..m. on December 2, 2021, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control and quality assessment 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 Mycoplasma pneumoniae quality control records review ( 2020-2021 ) and interview with the laboratory director on December 2, 2021 at 12:30 P.M., it was determined that the laboratory failed to include a negative and positive control material when performed Mycoplasma Pneumoniae test by Immuno Card method. The finding includes: a. The Mycoplasma pneumoniae quality control records showed that no positive neither negative control material were included each day of patient testing. Refer to D5449. -- 2 of 2 --