Laboratorio Clinico Ana Camila

Summary Statement of Deficiencies D0000 A Proficiency Test (PT) Desk Review off site survey was performed on June 2, 2025 to Laboratorio Clinico Ana Camila, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1403 Laboratory Director, Moderate 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 proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two consecutive testing events for the routine chemistry tests. The 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 -- finding includes: 1. The Puerto Rico Proficiency Testing and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Sodium a. Third testing event year 2024 - 0% b. First testing event year 2025 - 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for routine chemistry tests. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory has satisfactory participation for routine chemistry test during the third testing event 2024 and first testing event 2025. Refer to D2096 -- 2 of 2 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on BioSign Flu A+B manufacturer's instruction, Influenza A & B results reports records review and interview with the technical supervisor on June 19, 2018 at 9:34 AM, it was determined that the laboratory failed to follow manufacturer's instructions when 9 out of 9 patients specimens were tested and reported for Influenza A & B results from April 6, 2018 to June 11, 2018. The findings include: 1. The BioSign Flu A+B manufacture instructed the laboratory that the negative test results are presumptive and it is recommended these results be confirmed by viral culture; negative results do not preclude influenza virus infection and should not be used as sole basis for treatment or other management decision. 2. On June 19, 2018 at 9:34 AM, the Influenza A & B results reports records showed that 9 out of 9 patients specimens tested with the BioSign Flu A+B reagent kit were reported without the manufacturer required information . Also, those Influenza A & B reports include the information of the formed method (BinaxNow). 3. The technical supervisor confirmed on June 19, 2018 at 9:44 AM, that those reports did not include the manufacturer required information. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems 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 -- identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on quality assurance program, clinical consultant competence records review and technical supervisor interview on June 19, 2018 at 10:40 AM, it was determined that the laboratory failed to follow written protocol to assess the general laboratory system requirements. The findings include: 1. The quality assurance program establishes to perform an annual competence for the clinical consultant. 2. On June 19, 2018 at 10:40 AM, the clinical consultant competence records showed that the laboratory did not performed the annual competence since July 15, 2016. 3. The technical supervisor confirmed on June 19, 2018 at 10:50, that the last competence in records was performed on July 15, 2016. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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 Based on quality assurance program, clinical consultant competence records review and technical supervisor interview on June 19, 2018 at 10:40 AM, it was determined that the laboratory director failed to comply with the general laboratory system requirement. Refer to D 5791 (The laboratory failed to follow written protocol for the clinical consultant annual competence since July 15, 2016). -- 2 of 2 --