Laboratorio Clinico Paseos Ii

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Paseos II on March 5, 2026. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The following standard level deficiencies were found during the unannounced routine CLIA recertification survey ending on March 5, 2026. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on a review of Sperm Count Quality Control (QC) records (years 2024-2026), the manufacturer's instructions for QwikCheck Beads Control and the interview with the laboratory director on March 5, 2026, at 11:30 a.m., the laboratory failed to verify the manufacturer's stated values of the QwikCheck Beads Control prior to placing new controls lots into routine use. The laboratory processed and reported 210 out of 210 semen analysis patient samples from January 4, 2024, through March 4, 2026. The findings include: 1. The review of Sperm Count Quality Control (QC) records showed that the laboratory used QwikCheck beads control (Levels 1 and 2) to monitor the precision of semen analysis testing on the SQA V Sperm Quality Analyzer. (Reviewed on March 5, 2026, at 11:30 a.m.) 2. The manufacturer's instructions for 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 -- QwikCheck Beads Control establish that the laboratory must verify the manufacturer's stated values when a new control lot is introduced before placing the control materials into routine use. (Reviewed on March 5, 2026, at 11:40 a.m.) 3. The review of QC records showed that the laboratory placed the following lots of Sperm Count control materials into routine use without verifying the manufacturer's stated values: a. Control Lot: Level 1 (Lot 040423001) / Level 2 (Lot 040423002) Exp. Dates: 4/30 /2024 Use dates: January 4, 2024, through April 23, 2024. Patient samples processed and reported: 28 b. Control Lot: Level 1 (Lot 060823001) / Level 2 (Lot 060823002) Exp. Dates: 8/31/2024 Use dates: May 7, 2024, through August 27, 2024. Patient samples processed and reported: 18 c. Control Lot: Level 1 (Lot 031223001) / Level 2 (Lot 031223002) Exp. Dates: 12/31/2024 Use dates: September 3, 2024, through December 17, 2025. Patient samples processed and reported: 28 d. Control Lot: Level 1 (Lot 110724001) / Level 2 (Lot 110724002) Exp. Dates: 7/31/2025 Use dates: January 14, 2025, through July 24, 2025. Patient samples processed and reported: 59 e. Control Lot: Level 1 (Lot 060325001) / Level 2 (Lot 060325002) Exp. Dates: 3/31 /2026 Use dates: March 4, 2026, through December 30, 2025. Patient samples processed and reported: 39 4. During the interview on March 5, 2026, at 11:55 a.m., the laboratory director confirmed that the laboratory placed the Sperm Count control materials into routine use without first verifying the manufacturer's stated values. 5. The laboratory processed and reported 210 out of 210 semen analysis patient samples from January 4, 2024, through March 4, 2026. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 2024-2026) and interview with the laboratory director on March 5, 2026, at 1:00 p.m., the laboratory director failed to ensure compliance with the Hematology quality control requirements. Refer to D5469. -- 2 of 2 --

Summary Statement of Deficiencies D2071 SYPHILIS SEROLOGY CFR(s): 493.835(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 Puerto Rico Proficiency Testing Program records review ( years 2020 - 2021) and laboratory general supervisor interview on February 16, 2022 , it was determined that the laboratory obtained a test result score of 0% for the general immunology first testing event of year 2021. The finding includes: 1. The Puerto Rico Proficiency testing records were reviewed from February 2020 to December 2021 on February 16, 2022 at 9:15 AM. 2. For the general immunology, first testing event of year 2021, the report deadline was April 30, 2021. 3. The laboratory did not submit the results of the first testing event of year 2021 for general immunology on the date established by the Puerto Rico Proficiency Testing Program. 4. The laboratory general supervisor confirmed on February 16, 2022 at 9:35 A.M. that the laboratory did not report the general immunology proficiency testing results of the first testing event 2021 within the time frame established by the Proficiency Testing Program. The laboratory received a testing score of 0% in the first testing event of year 2021 for general immunology. 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) 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 -- The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A. Based on manufacturer's instructions, endocrinology quality control records review (years 2020-2022) and laboratory general supervisor interview on February 16, 2022 , it was determined that the laboratory failed to follow the manufacturer's instruction when patient specimen was tested for hCG qualitative (human chorionic gonadotropic) by Clarity Pregnancy One Step Rapid Test kit. The findings include: 1. The laboratory uses Clarity Pregnancy One Step Rapid Test kit when patient specimen were tested for hCG qualitative (human chorionic gonadotropic since January 2021. 2. The manufacturer's instructions on February 16, 2022 at 11:00 AM showed that a internal control was part of the testing cartridge. The manufacturer established that the internal control is a way used for validate the procedure: "A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural tecnique. The result is invalid if no red line appears in the control region (C), even if a line appears in the test region (T) you should repeat the test with a new test strip". 3. The endocrinology quality control records review from February 26, 2021 to February 11, 2022 on February 16, 2022 at 11:10 A.M., the records showed that the laboratory did not document the internal control which each on of the fifty seven (57) patiens's specimen tested for hCG qualitative during the above mentioned period of time. 4. The laboratory general supervisor stated on February 16, 2022 at 11:15 A.M. that the laboratory failed to document the internal control results with each sample patient test. B. Based on urinalysis quality control records review (years 2021-2022) and laboratory general supervisor interview on February 16, 2022 , it was determined that the laboratory failed to follow requirements for quality control when manual microscopic urinalysis examination were performed. 1. The laboratory uses urocheck strips for urinalysis patient samples tests. 2. Urinalysis quality control records were reviewed from January 2021 to January 2022 on February 16, 2022 at 10:00 AM. 3. The records showed that the laboratory did not include a microscopic negative control material when performed manual microscopic urinalysis examination since January 2021. 4. The laboratory performed and reported (993) nine hundred ninty three urinalysis patient samples in January 2021 to January 2022. 5. The laboratory general supervisor confirmed on February 16, 2022 at 10:15 A.M. that the laboratory did not include a microscopic negative control material each day of testing when performed manual microscopic urinalysis examination since January 2021. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that 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 Program (PRPTP) records review (years 2020-2021) and laboratory general supervisor interview on February 16, 2022 at 9:35 A.M., it was determined that the laboratory director failed to ensure that the general -- 2 of 4 -- immunology proficiency test report for first testing event of year 2021 were submitted within the established time frame. Refer to D2071. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, endocrinology quality control records review (years 2020-2022), urinalysis quality control (years 2021-2022) and laboratory general supervisor interview on February 16, 2022 at 11:50 A.M., it was determined that laboratory director failed to ensure that the quality control requirements were met. Refer to D5449. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate 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 manufacturer's instruction, endrocrinology quality control records review (years 2020-2022), urinalysis quality control (years 2021-2022) and laboratory general supervisor interview on February 16, 2022 at 11:50 A.M., it was determined that testing personnel failed to follow quality control procedures. Refer to D5449. 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 2020-2021) and the laboratory general supervisor interview on February 16, 2022 at 11:50 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 on medical technologist and technical supervisor (MT#1) and second medical technologist (MT #2) 2. The testing personnel records for MT #1 and -- 3 of 4 -- MT #2 showed on February 16, 2022 at 11:50 A.M that the laboratory did not include the following requirements in his competency evaluation performed in January 2021 and January 2022: 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. 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 manufacturer's instructions, endocrinology quality control records review (years 2020-2022), urnalysis quality control (years 2021-2022) and laboratory general supervisor interview on February 16, 2022 at 11:50 AM, it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. Refer to D5449. -- 4 of 4 --

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 POC ONE system manufacturer's instructions, urea breath testing records (years 2016 to 2018) review and technical supervisor interview on February 9, 2018 at 8:45 AM, it was determined that the laboratory failed to follow manufacturer's instruction when 49 out of 49 patients breath specimens were tested and reported for urea by the POC ONE system from August 31, 2016 to January 15, 2018. The findings include: 1 The POC one system manufacturer instructed the laboratory to perform and evaluate one per month the reproducibility test as quality control procedure of the POC one system. 2. The urea breath testing records (years 2016 to 2018) showed that the laboratory did not perform nor evaluate the reproducibility test of the POC one system from August 31, 2016 to January 15, 2018. 3. The technical supervisor confirmed on on February 9, 2018 at 8:50, that the laboratory did not perform nor evaluate the reproducibility test of the POC ONE system from August 31, 2016 to January 15, 2018. 4. The urea breath testing records (years 2016 to 2018) showed that the laboratory tested and reported 49 out of 49 patients breath specimens for urea by the POC ONE system from August 31, 2016 to January 15, 2018. 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 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 -- control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on manual and SQAV system sperm count testing records (years 2016 to 2018) review, lack of quality control records for manual sperm count and technical supervisor interview on February 9, 2018 at 10:10 AM, it was determined that the laboratory failed to include one control material each 8 hours of operation when one out of one patient specimen was processed for manual sperm cells counts by the hemocytometer from January 19, 2016 to February 8, 2018 (processed on May 17, 2016). The findings include: 1. The laboratory performed the sperm cell count by the SQAV system and by the the hemocytometer (those patients specimens they can not be counted by the SQAV system from January 19, 2016 to February 8, 2018 . 2. The manual and SQAV system sperm count testing records showed that one out of one patient specimen was processed for manual sperm cells counts by the hemocytometer from January 19, 2016 to February 8, 2018 (processed on May 17, 2016). 3. The laboratory did not perform the quality control procedures when one out of one patient specimen was processed for manual sperm cells counts by the hemocytometer on May 17, 2016. 4. The technical supervisor confirmed on February 9, 2018 at 10:10 AM, that the laboratory did not perform the quality control procedure on May 17, 2016. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on manual and SQAV system sperm cell count testing records (years 2016 to 2018), annual volume records (2016 and 2017) review and technical supervisor interview on February 9, 2018 at 10:10 AM, it was determined that the laboratory failed to evaluates twice a year the relationship of the sperm cell count results between the manual method (hematocytometer) and the SQAV system from January 19, 2016 to February 8,2018. The findings include: 1. The laboratory performed the sperm cell count by the SQAV system and by the the hemocytometer (those patients specimens that they can not be counted by the SQAV system) from January 19, 2016 to February 8, 2018. 2. The manual and SQAV system sperm cell count testing records showed that one out of 22 sperm cell counts was performed by the hemotocytometer method during the year 2016 (on May 17, 2016). 3. The laboratory did not evaluates twice a year the relationship of the sperm cell count results between the manual method (hematocytometer) and by the SQAV system from January 19, 2016 to February 8,2018. 4. The technical supervisor confirmed on February 9, 2018 at 10:10 AM, that the laboratory did not evaluates twice a year the relationship of the sperm cell count results between the manual method (hematocytometer) and by the SQAV system from January 19, 2016 to February 8,2018. 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 manual and SQAV system sperm count testing records (years 2016 to 2018), annual volume records (2016 and 2017) review review, lack of quality control records for manual sperm count and technical supervisor interview on February 9, 2018 at 10: 10 AM, it was found that the laboratory director failed to ensure compliance with the analytic system requirements for the sperm cells count. The findings include: 1. The laboratory director failed to ensure compliance with the analytic system requirements for the sperm cells count quality control. Refer to D 5543. 2. The laboratory director failed to ensure compliance with the analytic system requirements for the verification of the relationship of the sperm cell count results between the manual method (hematocytometer) and by the SQAV system. Refer to D 5775. D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for 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 manual and SQAV system sperm count testing records (years 2016 to 2018), annual volume records (2016 and 2017) review review, lack of quality control records for manual sperm count and technical supervisor interview on February 9, 2018 at 10: 10 AM, it was found that the , it was determined that technical supervisor failed to ensure compliance with the analytic system requirements for the sperm cells count. Refer to D 5543 Refer to D 5775. -- 3 of 3 --