Laboratorio Clinico La Morenita

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an initial CLIA survey at Laboratorio Clinico La Morenita on January 17, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the initial CLIA survey ending on January 17, 2025. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observation, manufacturer's instructions review and laboratory director interview on January 17, 2025 at 11:25 AM, it was determined that the laboratory failed to ensure proper storage for sodium citrate tubes that were not protected from direct light when the laboratory collected 15 patient samples on sodium citrate collection tubes for Prothrombin time (PT) and Partial thromboplastin time (PTT) patient tests for testing referral from October 7, 2024 to January 17, 2025. The findings include: a. On January 17, 2025 at 11:25 AM, the manufacturer's instructions of the BD Vacutainer sodium citrate collection tubes instructed the laboratory to protect from direct light the sodium citrate tubes. b. On January 17, 2025 at 11:25 AM, the laboratory sample collection area was observed. The laboratory uses BD Vacutainer sodium citrate collection tubes. Seven sodium citrate tubes were 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 -- observed stored under direct light. c. From October 7, 2024 to January 17, 2025, the laboratory collected 15 patient samples on sodium citrate collection tubes for referral of PT and PTT samples. d. The laboratory director confirmed on January 17, 2025 at 11:30 AM, that since October 7, 2024 to January 17, 2025, that the laboratory failed to ensure proper storage for sodium citrate tubes that were not protected from direct light. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on direct observation, manufacturer's instructions review and laboratory director interview on January 17, 2025 at 11:25 AM, it was determined that the laboratory director failed to ensure proper storage for sodium citrate tubes that were not protected from direct light, to provide quality laboratory services for all aspects of the test performance on samples collected in sodium citrate tubes. Refer to D5413. -- 2 of 2 --

Summary Statement of Deficiencies D2067 SYPHILIS SEROLOGY CFR(s): 493.835(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Puerto Rico Department of Health Proficiency Testing Program score records (year 2018) and interview with the testing personnel on December 18, 2018 at 11:00 AM, it was determined that the laboratory failed to participate in the second event of the syphilis serology proficiency testing in August 2018. The findings include: 1. The laboratory did not participate in the second event of the syphilis serology proficiency testing in August 2018. 2. The Puerto Rico Department of Health Proficiency Testing Program score records (year 2018) showed that the laboratory obtained a O percent score for the second event of syphilis serology in August 2018. 3. The testing personnel confirmed on December 18, 2018 at 11:00 AM, that the laboratory did not participate in the second event for the syphilis serology proficiency testing (August 2018). D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (PRPTP) records ( years 2017 and 2018) review and testing personnel interview on December 18, 2018 at 11:00 AM, it was determined that the laboratory failed to retain all proficiency testing records for at least 2 years. The findings include: 1. On December 18, 2018 at 11:00 AM, the PRPTP records showed that the laboratory did not retain the proficiency testing results for the seconds event of syphilis serology proficiency testing samples (August 2018). 2. The testing personnel confirmed on December 18, 2018 at 11:00 AM, that the laboratory did not have this records due to the laboratory did not participate in the August 2018 event. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on hematology procedures manual, Cell Dyn 1700 system validation records (October 19, 2016), manufacturer's instructions, complete cells count (CBC) quality control records review(years 2017 and 2018), laboratory director and testing personnel interview on December 18, 2018 at 10:35 AM, it was determined that the laboratory failed to meet with the analytic system requirements for CBC tests the Cell Dyn 1700 system since December 2016. Refer to D 5401 (The laboratory failed to have a written procedures manual for the CBC tests, processed by the Cell Dyn 1700 system since December 2016). Refer to D 5405 (The laboratory failed to follow manufacturer's instructions when 23 out of 23 CBC's patients specimens were tested by the Cell Dyn 1700 system from May 9, 2018 to July 6, 2018). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on hematology procedures manual, Cell Dyn 1700 system validation records (October 19, 2016) and testing personnel interview on December 18, 2018 at 10:35 AM, it was determined that the laboratory failed to have a written procedures manual for the CBC tests, processed by the Cell Dyn 1700 system since December 2016. The findings include: 1. On December 18, 2018 at 10:35 AM, the Cell Dyn 1700 system validation records showed that the laboratory performed the validation of the Cell Dyn 1700 system on October 19, 2016. 2. The hematology procedures manual showed that the laboratory did not include the information of the the Cell Dyn 1700 system (patients specimens processing, preventive maintenance and quality control -- 2 of 7 -- procedures). Instead, the hematology procedures manual includes all the information of the former CBC system (Coulter Act Diff). 3. The testing personnel confirmed that the hematology procedures manual was not actualized with the Cell Dyn 1700 system procedures(patients specimens processing, preventive maintenance and quality control procedures). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)