Cdt-Centro De Salud Mariano Rivera Ramos

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on July 7, 2025 to Laboratorio Clinico CDT Centro de Salur Mariano Rivera Ramos, 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 Puerto Rico Proficiency Testing scores (years 2024-2025) and 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 -- CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Hematocri (HCT) . 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 Puerto Rico Proficiency Testing scores (years 2024-2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two out consecutive testing events for Hematocrit (HCT) tests. The finding includes: 1. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Hematocrit (HCT) tests a. Third testing event year 2024 - 60% b. First testing event year 2025 - 60% 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 Puerto Rico proficiency testing scores (years 2024-2025) and CASPER Report 0155D scores, its was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for hematology tests. 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 Puerto Rico proficiency testing scores (years 2024-2025) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for Hematocrit (HCT) tests during the third testing event of the year 2024 and first testing event of the year 2025. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies 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) testing records review ( years 2021 to 2022) and interview with the laboratory director, it was determined that the laboratory did not include each day of testing an external positive and negative control material when 55 out of 55 patients specimens were tested and reported for of Mycoplasma pneumoniae from February 2, 2021 to September 24, 2021. The findings include: 1. The laboratory use the Immuno Card Mycoplasma Test Cassette to perform the Mycoplasma pneumoniae qualitative tests. 2. On February 17, 2022 at 11:03 AM, review of Mycoplasma pneumoniae testing record showed that the laboratory performed patient testing from February 2, 2021 to September 24, 2021. The laboratory did not include each day of testing the externals (positive nor the negative) control materials. 3. The laboratory director confirmed on February 17, 2022 at 11:10 AM, that the laboratory failed to include each day of testing the external negative and positive control material . She stated that the laboratory run the external controls when it received a new reagent kit. 4. The laboratory processed and reported 55 patients specimens for Mycoplasma pneumoniae from February 2, 2021 to September 24, 2021. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 -- 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 General Immunology (Mycoplasma pneumoniae test) testing records review ( years 2021 to 2022) and interview with the laboratory director , it was determined that the laboratory director to failed to ensure compliance with the analytic system requirements of General Immunology specialty from February 2, 2021 to September 24, 2021. Refer to D 5449 (The laboratory did not include each day of testing an external positive and negative control material when 55 out of 55 patients specimens were tested and reported for of Mycoplasma pneumoniae from February 2, 2021 to September 24, 2021). -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on laboratory test reports records (years 2017, 2018) review and laboratory director interview on February 2, 2018 at 12:15 PM, it was determined that the laboratory failed to indicate the laboratory name in the 100 per cent of the tests results reported by the laboratory information system from February 2, 2017 to February 2, 2018: hematology, routine chemistry, endocrinology, urinalysis, syphilis serology and general immunology. The findings include: 1. The laboratory names is CDT Centro de Salud Mariano Rivera Ramos. 2. On February 2, 2018 at 12:15 PM, the 100 per cent of the laboratory tests results (hematology, routine chemistry, endocrinology, urinalysis, syphilis serology and general immunology) reported by the laboratory information system showed that the laboratory information system included in those results reports the Centro De Diagnstico y Tratamiento Municipio De Cayey Laboratorio Clnico as the laboratory name from February 2, 2017 to February 2, 2018. 3. The laboratory director confirmed on February 2, 2018 at 12:20 PM, that those tests result reports included the former laboratory name. She stated that the laboratory information system had not been updated yet. . D6098 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1445(e)(8) The laboratory director must ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on laboratory test reports records (years 2017, 2018) review and laboratory director interview on February 2, 2018 at 12:15 PM, it was determined that the laboratory laboratory director failed to ensure that the laboratory tests results reported by the laboratory information system indicate the laboratory name from February 2, 2017 to February 2, 2018. Refer to D 5805. ( The laboratory failed to indicate the laboratory name in the 100 per cent of the tests results reported by the laboratory information system from February 2, 2017 to February 2, 2018: hematology, routine chemistry, endocrinology, urinalysis, syphilis serology and general immunology). -- 2 of 2 --