Laboratorio Clinico Caribe

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Caribe, on August 26, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. During a recertification survey on August 26, 2025, the laboratory was found out of compliance with the following conditions: 42 CFR 493.1208 General Immunology 42 CFR 493.1212 Endocrinology 42 CFR 493.1441 Laboratory Director D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Mycoplasma pneumoniae quality control records, patient test worksheets review (2024 -2025), and interview with the laboratory general supervisor on August 26, 2025, at 10:50 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for Mycoplasma pneumoniae tests. Refer to D5449(A) The findings include: 1. The laboratory failed to include external positive and negative control material each day of patient testing. D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. 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 -- This CONDITION is not met as evidenced by: Based on Human Chorionic Gonadotropin (hCG) quality control records, patient test worksheets review (2024 - 2025), and interview with the laboratory general supervisor on August 26, 2025, at 10:25 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for hCG tests. Refer to D5449(B) The findings include: 1. The laboratory failed to include an external positive and negative control material each day of patient testing. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: A. Based on Mycoplasma pneumoniae quality control records, patient test worksheets review (2024 - 2025), and interview with the laboratory general supervisor on August 26, 2025, at 10:50 AM, it was determined that the laboratory failed to include external positive and negative control material each day of patient testing, when processed and reported 252 out of 271 Mycoplasma pneumoniae patient specimens from March 20, 2024, to August 7, 2025. The findings include: 1. The laboratory used the Meridian Diagnostics ImmunoCard Mycoplasma to perform Mycoplasma pneumoniae on patient specimens. 2. Review of the Mycoplasma pneumoniae quality control records and patient test worksheets on August 26, 2025, at 10:50 AM, showed that the laboratory failed to include external positive and negative control material each day of patient testing. 3. The laboratory processed and reported 252 out of 271 Mycoplasma pneumoniae patient specimens from March 20, 2024, to August 7, 2025, without external controls. 4. On August 26, 2025, at 11:00 AM, the laboratory general supervisor confirmed that the laboratory did not include external positive and negative control material each day of patient testing. B. Based on the human Chorionic Gonadotropin (hCG) quality control records, patient test worksheets review (2024 - 2025), and interview with the laboratory general supervisor on August 26, 2025, at 10: 25 AM, it was determined that the laboratory failed to include external positive and negative control material each day of patient testing, when processed and reported 34 out of 63 hCG patient specimens from March 16, 2024, to July 9, 2025. The findings include: 1. The laboratory used the AimStep Combo Pregnancy Test to perform hCG testing in serum patient specimens. 2. Review of hCG quality control records and patients test worksheets on August 26, 2025, at 10:25 AM, showed that the laboratory failed to include external positive and negative control material each day of patient testing. 3. The laboratory processed and reported 34 out of 63 patient specimens from March 16, 2024, to July 9, 2025,without external controls. 4. On August 26, 2025, at 10:45 AM, the laboratory general supervisor confirmed that the laboratory did not include external positive and negative control material each day of patient testing. 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: -- 2 of 3 -- Based on Mycoplasma pneumoniae and hCG quality control records, patients test worksheets review (2024 -2025), and interview with the laboratory general supervisor on August 26, 2025, at 1:00PM, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the analytic system requirements for Mycoplasma pneumoniae and hCG patient testing. Refer to D6093. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 Mycoplasma pneumoniae and hCG quality control records, patient test worksheets review (2024 -2025), and interview with the laboratory general supervisor on August 26, 2025, at 1:00PM, it was determined that the laboratory director failed to ensure that the general supervisor monitored compliance with the analytic system requirements for Mycoplasma pneumoniae and hCG patient testing. Refer to D6144. 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 Mycoplasma pneumoniae and hCG quality control records, patient test worksheets review (2024 -2025), and interview with the laboratory general supervisor on August 26, 2025, at 1:00PM, it was determined that the laboratory general supervisor failed to ensure inclusion of external positive and negative control material each day of patient testing. Refer to D5449 (A) and (B). -- 3 of 3 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on laboratory room temperature and relative humidity records review (years 2022-2023) and laboratory general supervisor interview at 11:15 AM. on September 26, 2023, it was determined that the laboratory failed to monitor the room temperature and relative humidity as establishes. The findings include: 1. The laboratory room temperature and relative humidity records were reviewed from January 2, 2023 to September 25, 2023. Reviewed at 11:15 AM. 2. The laboratory establishes that the room temperature must be between 23 to 30 C and relative humidity was between 35 to 70 %. Reviewed at 11:20 AM. 3. From January 2, 2022 to September 25, 2023, the records showed that the laboratory documented temperatures below 23 C on 85 out of 205 days;and relative humidity below 35 % on 173 out of 205 days. Reviewed at 11: 35AM. 4. The laboratory general supervisor confirmed on September 26, 2023 at 11: 40 AM that the laboratory failed to monitor the room temperature and relative humidity as established. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 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 -- applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (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 Immuno Card Mycoplasma manufacturer's instructions, General Immunology (Mycoplasma pneumoniae) testing record review from March 2, 2023 to September 25, 2023 and interview with the laboratory general supervisor on September 26, 2023 at 10:10 AM, it was determined that the laboratory failed to follow the manufacturer's instruction when 155 out of 155 patients specimens were tested and reported for of Mycoplasma pneumoniae from March 2, 2023 to September 25, 2023. The findings include: 1. The laboratory use the Immuno Card Mycoplasma Test to perform the Mycoplasma pneumoniae qualitative tests. 2. The manufacturer's instruction establishes to perform the test procedures at room temperature range from 22 to 25 C. ( review on September 26, 2023 at 10: 10 A.M. ) 3. On September 26, 2023 at 10:30 AM, review of the Mycoplasma pneumoniae testing records showed that the laboratory did not monitor nor document the room temperature when patient's specimens were tested for Mycoplasma by Immuno Card Meridian method from March 2, 2023 to September 2023. 4. The laboratory general supervisor confirmed on September 26, 2023 at 10:40 AM, that the laboratory did not monitor nor document the room temperature when it processed the patients specimens for Mycoplasma pneumoniae test. 5. The laboratory processed and reported 155 out of 155 patient samples for Mycoplasma pneumoniae test from March 2, 2023 to September 26, 2023. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation of preventive maintenance of the laboratory equipments (years 2022-2023) and laboratory general supervisor interview on September 26, 2023 at 9: 30 AM, it was determined that the laboratory failed to perform the preventive maintenance of the following equipments: centrifuge, microscope, rotator and mixer annually as established. The findings include: 1. The laboratory stablishes as preventive maintenance of the following equipments centrifuge, microscope, rotator and mixer must be perform annually. Reviewed at 9:30 AM. 2. The laboratory equipment (centrifuge, microscope, rotator and mixer) showed a label that indicates that the last certification was peformed on September 2021. Reviewed at 9:40 AM. 3. The laboratory general supervisor confirmed on September 26, 2023 at 9:450 AM, that these preventive maintenance must be perform annually and that the laboratory failed to ensure that these preventive maintenance were performed as establishes. -- 2 of 4 -- D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on hematology quality control records review (years 2022-2023) and laboratory general supervisor interview on September 26,2023 at 10:40 AM, it was determined that the laboratory failed to check, each day of use, the Wright's stain used in hematology for intended reactivity to ensure predictable staining characteristics. The findings include: 1. From January 14, 2022 to September 25, 2023, the records showed that the laboratory did not check nor document the reactivity of Wright's stain reagent, each day of use, since January 2, 2023. 2. The laboratory processed and reported nineteen (19) WBC (white blood cell) differential manual since January 2, 2023. 3. The laboratory general supervisor confirmed on September 26, 2023 at 10:40 AM, that the laboratory failed to check, each day of use, the Wright's stain used in hematology. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 hematology quality control records review (years 2022-2023), general immunology quality control records review (years 2022-2023), room temperature and relative humidity records review (years 2022-2023), preventive maintenance for equipments records review (2022-2023) and laboratory general supervisor interview at 11:45 AM on September 26, 2023, it was found that the laboratory director did not assure that quality control procedures related to evaluation of Wright stain for WBC (White blood cell) differential manual, laboratory maintenance equipments, follow manufacturer's instruction for Mycoplasma patient's tests and monitor room temperature and relative humidity as established. Refer to D5411, D5413, D5435 and D5473. 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 hematology quality control records review (years 2022-2023), general immunology quality control records review (years 2022-2023), room temperature and -- 3 of 4 -- relative humidity records review (years 2022-2023), preventive maintenance for equipments records review (2022-2023) and laboratory general supervisor interview at 11:45 AM on September 26, 2023, it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. Refer to D5411, D5413, D5435 and D5473. -- 4 of 4 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 refrigerator temperature records review (years 2018-2019) and laboratory general supervisor interview at 11:15 AM on October 22, 2019, it was determined that the laboratory failed to monitor the refrigerator temperature used to storage the hematology controls, routine chemistry reagents and endocrinology reagents. The findings include: 1. On October 22, 2019 at 11:15 AM the laboratory refrigerator temperature records (January 2018 to October 21, 2019) were reviewed. 2. The manufacturer's establishes that hematology controls, routine chemistry and endocrinology reagents must be storage at a temperature between 2-8 C . 3. Review of the refrigerator temperature records showed that the documented temperature was out of range on 21 out of 491 days. Eight days were recorded at 1 C and thirteen at 9 C. 4. The laboratory general supervisor confirmed on October 22, 2019 that the laboratory did not assure the adequate reagent storage temperature during the years 2018 and 2019. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system 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 3 -- laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on hematology calibration records reviewed (years 2018-2019) and laboratory general supervisor interview on October 22, 2019 at 11:00 AM, it was determined that the laboratory failed to perform the calibration verification procedures with at least the frequency recommended by the manufacturer's (each six months) for the hematology tests performed by the Horiba Pentra 60 C+ system. The findings include: 1. The laboratory uses a Pentra 60 C+ hematology system for CBC (Complete blood count) patient's tests since April 1, 2018. 2. The manufacturer's instructions establishes that the laboratory must perform the calibration verification procedures each six months. 3. From March 2018 to October 22, 2019, the records showed that the laboratory did not perform at least every 6 months the calibration verification procedures for the Pentra 60 C+ hematology system. The calibration verification procedures were done on October 2018 and July 2019. 4. The laboratory processed and reported One thousand thirty seven (1037) Complete blood count (CBC) patient's samples from November 2018 to July 2019. 5. The laboratory general supervisor confirmed on October 22, 2019 that the laboratory did not perform at least every 6 months the calibration verification procedures for the Pentra 60 C+ hematology system. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on syphillis serology quality control records review (years 2018-2019) and laboratory general supervisor interview at 9:30 AM on October 22, 2019, it was determined that the laboratory did not evaluate the new lot of Rapid Plasma reagin (RPR) test by Detector RPR Method for positive and negative reactivity prior to placed it in routine use. The findings include: 1. The laboratory quality control records were review from January 2018 to October 21, 2019. 2. The laboratory received the following reagent kit for Detector RPR Method and no evaluation of their reactivity was performed: Test Lot Expiration Date RPR 9514 3/31/2021 3. The laboratory processed and reported one hundred sixty eight (1682) RPR (Rapid plasma reagin) -- 2 of 3 -- patient's samples since March 4, 2019. 4. The laboratory general supervisor confirmed on October 22, 2019 that the laboratory did not evaluate the new lot of Rapid Plasma reagin (RPR) test for positive and negative reactivity prior to placed it in routine use. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) 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 hematology and syphillis serology quality control records review (years 2018-2019) and laboratory general supervisor interview at 11:30 AM on October 22, 2019, it was found that the laboratory director did not assure that quality control procedures related to calibration verification and evaluation of new reagents lots were followed. The findings include: 1. The laboratory did not perform, each six months, calibration verification procedures for hematology. Refer to D5437. 2. The laboratory did not evaluate the new RPR reagent kit. Refer to D5471. 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 quality control records review(years 2018-2019) and laboratory general supervisor interview at 11:30 AM on October 22, 2019, it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. Refer to D6177. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high 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 quality control records review (years 2018-2019) and laboratory general supervisor interview at 11:30 AM on October 22, 2019, it was determined that testing personnel failed to follow quality control procedures. The findings include: 1. The testing personnel failed to monitor and take remedial actions when the refrigerator temperature was out of range. Refer to D5413. 2. The testing personnel failed did not followed the manufacturer instructions related to hematology calibration verification procedures. Refer to D5437. 3. The testing personnel did not evaluate new RPR reagent lots. Refer to D5471. -- 3 of 3 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --