Lab Clinico Cdt Dr Cesar R Rosa Febles

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on August 18, 2025 to Laboratorio Clinico CDT Dr. Csar R. Rosa Febles, 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 Puerto Rico Proficiency Testing Service Program (PRPTSP) scores (years 2024-2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for T3 Uptake tests. Refer D2107. 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 -- D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing 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 Service Program (PRPTSP) scores (years 2024-2025) and CASPER Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two out of three consecutive testing events for Triiodothyronine (T3) uptake tests. The finding includes: 1. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: T3 Uptake a. Third testing event year 2024 - 40% b. Second testing event year 2025 - 40% 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 Puerto Rico Proficiency Testing Service Program (PRPTSP) 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 T3 Uptake 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 Puerto Rico Proficiency Testing Service Program (PRPTSP) 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 T3 Uptake tests during the third testing event of the year 2024 and second testing event of the year 2025. Refer to D2107. -- 2 of 2 --

Summary Statement of Deficiencies 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 identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records (years 2022-2023) and laboratory director interview on March 14, 2024 at 2:00 PM, it was determined that the laboratory failed to evaluate and monitor the patient confidentiality, specimen identification and integrity, complaint investigation, communication, and personnel competency in the general laboratory system since January 2022. The findings include: 1. On March 14, 2024 at 2:00 PM, the general laboratory system QA 2022- 2023 records were requested. The general laboratory system QA was not available for evaluation. 2. The laboratory director confirmed on March 14, 2024 at 2:02 PM, that the QA general laboratory system activities records were not evaluated or monitored since January 2022. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records (years 2022-2023) 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 4 -- laboratory director interview on March 14, 2024 at 2:03 PM, it was determined that the laboratory failed to evaluate Quality Assessment Program and monitor the requirements for pre-analytic systems since year 2022. The findings include: 1. On March 14, 2024 at 2:03 PM, the laboratory pre-analytic systems QA records 2022- 2023 were requested. The pre-analytic system QA since year 2022 was not available for evaluation at the time of inspection. 2. Since January 2022 the laboratory did not evaluate practices related to: test request, specimen submission and handling, and specimen referral. 3. The laboratory director confirmed on March 14, 2024 at 2:05 PM, that the laboratory pre-analytic systems QA records 2022-2023 were not evaluated or monitored since January 2022. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on hematology calibration verification records, manufacturer's instructions, and laboratory director interview on March 14, 2024 at 10:00 AM, it was determined that the laboratory failed to perform the calibration verification procedures with at least the frequency recommended by the manufacturer's instructions (every six months) for the hematology tests performed by the XN-550 hematology system. The findings include: 1. The laboratory uses a XN-550 hematology system for CBC (Complete blood count) patient's tests. 2. Review of the manufacturer's instructions on March 14, 2024 at 10: 02 AM showed that the laboratory must perform the calibration verification procedures every six months. 3. On March 14, 2024 at 10:00 AM, the calibration verification records of XN-550 hematology system showed that the laboratory did not perform at least every 6 months the calibration verification procedures. The calibration verification procedures were done on April 1 2022, and April 11, 2023. 4. The laboratory processed and reported 12,286 CBC patient samples from October 1, 2022 to March 14, 2024. 5. The laboratory director confirmed on March 14, 2024 at 10:05 AM, that the laboratory did not perform at least every 6 months the calibration verification procedures for the XN-550 hematology system. -- 2 of 4 -- D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Human chorionic gonadotropin (hCG) manufacturer's instructions, worksheet records review and laboratory director interview on March 14, 2024 at 01: 18 PM, it was determined that the laboratory failed to follow manufacturer's instructions to document the internal control each day of patient testing when processing hCG samples. The findings include: 1. The laboratory performed (hCG) human chorionic gonadotropin by Alere hCG Combo Cassette kit. 2. Review of the manufacturer's instructions on March 14, 2024 at 01:15 PM showed that the laboratory must monitor and document the internal control to ensure the validity of the hCG test performed. 3. The hCG test worksheet records showed on March 14, 2024 at 01:18 PM, that the laboratory did not document the observed results of the internal procedural control with each day of patient testing when processing hCG samples. 4. The laboratory processed and reported 207 hCG patient samples from May 1, 2022 to March 14, 2024. 5. The laboratory director confirmed on March 14, 2024 at 01:23 PM, that the laboratory did not monitor and document the internal control with each day of patient testing when processing hCG samples. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on lack of Quality Assessment (QA) activities records (years 2022-2023) and laboratory director interview on March 14, 2024 at 2:06 PM, it was determined that the laboratory failed to evaluate Quality Assessment Program and monitor the requirements for analytic systems since year 2022. The findings include: 1. On March 14, 2024 at 2:06 PM, the laboratory analytic systems QA records 2022-2023 were requested. The analytic system QA since year 2022 was not available for evaluation at the time of inspection. 2. Since January 2022 the laboratory did not evaluate practices related to: test procedures, accurate and reliable test system, equipment instruments, reagents, materials, specimen and reagent storage conditions, system naintenance and fucntion checks, verification of method performance specifications, calibration, control procedures, test records,

Summary Statement of Deficiencies D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on personnel records files review (years 2021-2022) and the laboratory director interview on April 13, 2022 at 10:00 AM, it was determined that the laboratory failed to ensure that a comprehensive mechanism is used to evaluate the competency of the testing personnel. The finding includes: 1. The laboratory testing personnel includes five medical technologists and laboratory general supervisor. 2. The testing personnel records for MT #1, 2, 3, 4, and 5 showed on April 13, 2022, 2022 at 10:10 AM that the laboratory did not include the following requirements in his competency evaluation performed in December 2021: a. Direct observations of routine patient test performance , including patient preparation, if applicable, specimen handling, processing and testing. b. Monitoring the recording and reporting of test results. c. Review of intermediate test results or worksheets, quality control records, proficiency testing record and preventive maintenance records. d. Direct observation of performance of instrument maintenance and function checks. e. Assessment of problem solving skills. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --