Lab Clinico Bayamon

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Laboratorio Clnico Bayamon on November 17, 2025. 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 November 17, 2025. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 lack of routine chemistry and endocrinology calibration verification records review (years 2024 - 2025) and laboratory director interview on November 17, 2025, at 10:46 AM , it was found that the laboratory did not perform , at least every 6 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 -- months, the calibration verification procedures for the following routine chemistry and endocrinology tests: carcinoembryonic Antigen (CEA), follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (Prol), thyroxine binding globulin uptake (T3 uptake), Vitamin B-12, Vitamin D by the Vitros 7600 Chemistry and Endocrinology analyzer. The laboratory processed and reported 6,862 out of 6,862 patient samples from February 2025 to November 2025. The findings include: 1. The laboratory validated the Vitros 7600 analyzer on January 21, 2025 and began to perform routine chemistry and endocrinology tests on February 2025. (Review on November 17, 2025 at 10:21 AM). 2. During interview with the laboratory director the calibration verification were requested on November 17, 2025 at 10:40 AM. The calibration verification were not performed for the following analytes: carcinoembryonic Antigen (CEA), follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (Prol), thyroxine binding globulin uptake (T3 uptake), Vitamin B-12, Vitamin D. 3. The laboratory director stated on November 17, 2025, at 10:46 AM, that the calibration verification was not carried us during the year 2025. 4. The laboratory processed and reported 6,862 out of 6,862 patient samples from February 2025 to November 2025 for the following routine chemistry and endocrinology tests: carcinoembryonic Antigen (CEA), follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (Prol), thyroxine binding globulin uptake (T3 uptake), Vitamin B-12, Vitamin D by the Vitros 7600 Chemistry and Endocrinology analyzer. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) (b)(3) 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 lack of routine chemistry and endocrinology calibration verification records review (years 2024 - 2025) and laboratory director interview on November 17, 2025, at 10:46 AM , it was found that the laboratory testing personnel failed to perform the calibration verification at least every 6 months for the following routine chemistry and endocrinology tests: carcinoembryonic Antigen (CEA), follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (Prol), thyroxine binding globulin uptake (T3 uptake), Vitamin B-12, Vitamin D by the Vitros 7600 Chemistry and Endocrinology analyzer. The laboratory processed and reported 6,862 out of 6,862 patient samples from February 2025 to November 2025. Refer to D5439. 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 lack of routine chemistry and endocrinology calibration verification records review (years 2024 - 2025) and laboratory director interview on November 17, 2025, at 10:46 AM , it was found that the laboratory director failed to ensure that the calibration verification were performed at least every 6 months for the following -- 2 of 3 -- routine chemistry and endocrinology tests: carcinoembryonic Antigen (CEA), follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (Prol), thyroxine binding globulin uptake (T3 uptake), Vitamin B-12, Vitamin D by the Vitros 7600 Chemistry and Endocrinology analyzer. The laboratory processed and reported 6,862 out of 6,862 patient samples from February 2025 to November 2025. Refer to D5439. -- 3 of 3 --

Summary Statement of Deficiencies 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 quality control records review, procedural manual of the instrument and laboratory director interview on December 19, 2023 at 1:53 PM, it was determined that the laboratory failed to perform the calibration verification procedures with at least the frequency recommended by the manufacturer (each six months) for the hematology tests performed by the Sysmex XN-550 system. The findings include: 1. The laboratory uses a Sysmex XN-550 hematology system for CBC (Complete 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 -- blood count) patient's tests. 2. On December 19, 2023 at 1:35 PM, the procedural manual of the instrument was review and showed that the laboratory must perform the calibration verification procedures each six months. 3. On December 19, 2023 at 1:47 PM, the quality control was reviewed. From February 24, 2022 to December 20, 2023 the laboratory did not perform at least every 6 months the calibration verification procedures for the Sysmex XN-550 hematology system since October 12, 2021. 4. The laboratory director confirmed on December 19, 2023 at 1:53 PM that the laboratory did not perform at least 6 months the calibration verification procedures for the Sysmex XN-550 system. Since January 2022 to December 19, 2023 the laboratory processed and reported approximately 20,000 patient's samples. 5. The laboratory did not verify whether the test system is providing accurate results throughout the reportable range. 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 specialty, records review (year 2022 and 2023), procedural manual of the instrument and interview with the laboratory director on December 19, 2023 at 3:16 PM; it was determined that the laboratory director failed to ensure that the calibration verification of the Sysmex XN-550 were performed. Refer to D5439. -- 2 of 2 --

Summary Statement of Deficiencies D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Xpert Chlamydia trachomatis (CT) /Neisseria gonorrhea (NG) Assay (GeneXpert system) testing records, l from December 18, 2017 to January 2, 2020 reviewed, technical consultant (MT # 4) and technical supervisor (MT # 3) interview on January 3, 2020 at 10:21 AM, it was determined that the laboratory failed to meet with the requirement for bacteriology subspecialty (detection of the Xpert CT/NG tests). Refer to D 5449 - The laboratory did not include each day of testing a negative and a positive control material when patient's specimens were tested and reported for the detection of Xpert CT/NG from December 18, 2017 to January 2, 2020. 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 Immuno Concepts HEp-2000 Colorzyme ANA-Ro manufacturer's instruction, antinuclear antibody (ANA) qualitative testing records (years 2017 to 2020), ANA tests reports records, procedures manual reviewed and interview with the technical supervisor (TM#3) at 10:10 AM on January 3, 2020, it was determined that Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- the laboratory failed to meet the requirement of the General Immunology specialty (ANA tests). Refer to D 5405 (1) Refer to D 5405 (2) D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: 1. Based on Immuno Concepts HEp-2000 Colorzyme ANA-Ro manufacturer's instruction, antinuclear antibody (ANA) qualitative testing records (years 2017 to 2020), ANA tests reports records reviewed and interview with the technical supervisor (TM#3) at 10:10 AM on January 3, 2020, it was determined that the laboratory failed to follow manufacturer's instructions for the step by step performance of the ANA screening qualitative tests when 901 out of 913 patient's specimens were processed and reported for ANA tests from January 9, 2017 to January 2, 2020. The findings include: a. The laboratory performed manually the ANA qualitative tests by Immuno Concepts HEp-2000 Colorzyme ANA-Ro method to determine a screening qualitative ANA pattern detection in patients specimens from January 9, 2017 to January 2, 2020. b. The Immuno Concepts HEp-2000 Colorzyme ANA-Ro manufacturer instructed the laboratory for the screening ANA test to dilute patient sample to 1:40 by adding 0.05 ml patient serum to 1.95 ml reconstitute phosphate buffered saline (PBS). c. On January 3, 2020 at 10:10 AM. the ANA qualitative testing records showed that the laboratory did not document the step by step performance of the ANA screening procedures. The laboratory did not document in the testing records the 1:40 dilution when it processed the ANA screening tests in 901 out of 913 patient's specimens from January 9, 2017 to January 2, 2020. The laboratory documented in the testing records the interpretation of patients results performed by the microscopic examination (positive or negative results). d. The technical supervisor (TM#3) confirmed on January 3, 2020 at 10:10 AM, that the laboratory did not document the patient's serum 1:40 dilution of those patient's sample. He stated that the laboratory performed the dilutions but only recorded the interpretation of patients results performed by the microscopic examination. 2. Based on Immuno Concepts HEp-2000 Colorzyme ANA- Ro manufacturer's instruction, antinuclear antibody (ANA) qualitative testing records (years 2017 to 2020), ANA tests reports records, procedures manual reviewed and interview with the technical supervisor (TM#3) at 10:10 AM on January 3, 2020, it was determined that the laboratory failed to follow manufacturer's instructions for the reporting of the ANA screening results when 216 out of 216 were reported with positive results for ANA tests from January 9, 2017 to January 2, 2020. The findings include: a. The laboratory performed manually the ANA qualitative tests by Immuno Concepts HEp-2000 Colorzyme ANA-Ro method to determine a screening qualitative ANA pattern detection in patient's specimens from January 9, 2017 to January 2, 2020. b. The Immuno Concepts HEp-2000 Colorzyme ANA-Ro manufacturer instructed the laboratory for the reporting of results of the screening ANA test that the results should be reported as strongly positive or positive at the 1:40 dilution, and the nuclear pattern should be reported. c. On January 3, 2020 at 10:10 AM. the ANA tests reports records showed that the laboratory reported 216 out of 216 patient's ANA reports as positive 1:40 with the nuclear staining pattern. The laboratory reported those patient's specimens as final result, the 216 ANA tests reports did not indicate -- 2 of 5 -- that the tests is a screening test. d. The procedures manual was not revised since January 23, 2012. The procedures manual did not include instructions for the reporting of the ANA screening test. e. The technical supervisor (TM#3) confirmed during the interview on January 3, 2020 at 10:10 AM, that the laboratory reported those patient's specimens as final result, the 216 out of 216 ANA tests reports were reported positive 1:40 and those did not indicate that the ANA tests is a screening test. 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) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Xpert Chlamydia trachomatis (CT) /Neisseria gonorrhea (NG) Assay testing records, quality control from December 18, 2017 to January 2, 2020 reviewed, technical consultant (MT # 4) and technical supervisor (MT # 3) interview on January 3, 2020 at 10:21 AM, it was determined that the laboratory did not include each day of testing a negative and a positive control material when 2,474 out of 2,474 patient's specimens were tested and reported for detection of Xpert CT/NG from December 18, 2017 to January 2, 2020 by GeneXpert system. The findings include: 1. The laboratory used the Xpert CT/NG Assay (GeneXpert system) for detection of Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) in patient's samples. 2. On January 2, 2020 at 10:21 AM, the Xpert CT/NG testing records showed that the laboratory did not include each day of testing the negative and positive control materials when 2,474 out of 2,474 patient's specimens were processed from December 18, 2017 to January 2, 2020. 3. The laboratory includes the negative and the positive control materials when it placed in routine use the following lots numbers of Xpert CT /NG reagents kit: Date open lots # exp. Date 12/18/2017 1000066568 7/7/2018 01/08 /2018 1000066568 7/7/2018 02/16/2018 1000075665 11/03/2019 03/23/2018 1000079148 01/19/2019 05/28/2018 1000081930 03/22/2020 06/29/2018 1000099036 12/22/2019 07/11/2018 1000099036 12/22/2019 10/16/2018 1000099023 05/17/2020 01/12/2019 1000098734 05/03/2020 02/14/2019 1000141793 03/14/2020 04/24/2019 1000141793 03/14/2020 08/26/2019 1000162385 05/30/2020 4. The general supervisor (Technical Supervisor - MT # 3) and testing personnel (Technical Consultant - MT # 4) confirmed on January 3, 2020 at 10:21 AM, that the laboratory did not include the negative and the positive control materials each day of testing, instead the laboratory includes a negative and a positive control materials when it placed in routine use every new lot or new shipping of Xpert CT/NG reagents kit. 5. The laboratory tested and reported 2,474 out of 2,474 patient's specimens for the detection of CT/NG tests from December 18, 2017 to January 2, 2020 by the Xpert CT/NG system. 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. -- 3 of 5 -- This CONDITION is not met as evidenced by: Based on Immuno Concepts HEp-2000 Colorzyme ANA-Ro manufacturer's instruction, antinuclear antibody (ANA) qualitative testing records (years 2017 to 2020), ANA tests reports records, procedures manual, Xpert CT/NG testing records, Xpert CT/NG quality control from December 18, 2017 to January 2, 2020 reviewed, interview with the technical supervisor (TM#3) and testing personnel (TM # 4) interview on January 3, 2020 at 10:21, it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the laboratory analytical system. The finding includes: 1. The laboratory director did not comply with the analytical systems requirements. Refer to D 6093. 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 Immuno Concepts HEp-2000 Colorzyme ANA-Ro manufacturer's instruction, antinuclear antibody (ANA) qualitative testing records (years 2017 to 2020), ANA tests reports records, procedures manual, Xpert CT/NG testing records, Xpert CT/NG quality control from December 18, 2017 to January 2, 2020 reviewed, interview with the technical supervisor (TM#3) and testing personnel (TM # 4) interview on January 3, 2020 at 10:21, it was determined that the laboratory director failed to comply with the requirement of the General Immunology specialty (ANA tests) and Bacteriology subspecialty (detection of the Xpert CT/NG tests). Refer to D 5002 Refer to D 5014. D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on Immuno Concepts HEp-2000 Colorzyme ANA-Ro manufacturer's instruction, antinuclear antibody (ANA) qualitative testing records (years 2017 to 2020), ANA tests reports records, procedures manual reviewed and interview with the technical supervisor (TM#3) at 10:10 AM on January 3, 2020, it was determined that the technical supervisor failed to fulfill his responsibilities and duties to ensure compliance with the laboratory analytical system (ANA tests). Refer to D 6117. 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 -- 4 of 5 -- 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 Immuno Concepts HEp-2000 Colorzyme ANA-Ro manufacturer's instruction, antinuclear antibody (ANA) qualitative testing records (years 2017 to 2020), ANA tests reports records, procedures manual reviewed and interview with the technical supervisor (TM#3) at 10:10 AM on January 3, 2020, it was determined that the technical supervisor director failed to comply with the requirement of the General Immunology specialty (ANA tests). Refer to D 5014. 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 Xpert Chlamydia trachomatis (CT) /Neisseria gonorrhea (NG) Assay testing records, quality control from December 18, 2017 to January 2, 2020 reviewed, technical consultant (MT # 4) and technical supervisor (MT # 3) interview on January 3, 2020 at 10:21 AM, it was determined that the testing personnel failed to follow quality control procedures. Refer to D5449 - The laboratory did not include each day of testing a negative and a positive control material when patients were tested and reported for detection of Xpert CT/NG from December 18, 2017 to January 2, 2020. -- 5 of 5 --

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 --