Laboratorio Clinico Tiago

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 ImmunoCard Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing record review (year 2022-2023) and general supervisor interview on December 28, 2023 at 12:45 PM; it was determined that the laboratory failed to follow the manufacturer's instruction regarding to the established temperature range for Mycoplasma pneumoniae when 731 out of 2136 patient's specimen were processed and reported for Mycoplasma pneumoniae from January 2, 2023 to December 27,2023. The findings include: 1. The laboratory use the Immuno Card Mycoplasma Test to perform the Mycoplasma pneumoniae qualitative test. (Reviewed on December 28,2023 at 12:45 PM) 2. The manufacturer's instructions establish to perform the test procedures between 22 to 25C. (Reviewed on December 28,2023 at 12:45 P.M.) 3. On December 28,2023 at 12:50 PM, the Mycoplasma pneumoniae testing records showed that from January 2,2023 to December 27,2023, the laboratory processed and reported 731 out of 2136 patient's specimens with a temperature range within 20 to 21C. 4. The general supervisor confirmed during interview on December 28,2023 at 1:00PM, that the laboratory processed patient's samples outside the established temperature range. D6093 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- 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 Mycoplasma pneumoniae manufacturer's instructions, Mycoplasma pneumoniae testing records and general supervisor interview on December 28,2023, at 2:30PM it was determined that the laboratory director did not assure that the manufacturer's instructions were followed by the general supervisor regarding to temperature range for Mycoplasma pneumoniae test, when the laboratory processed and reported 731 out of 2136 patient's specimens for Mycoplasma pneumoniae. Refer to D5413. 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 manufacturer's instructions, Mycoplasma pneumoniae testing records and laboratory general supervisor interview on December 28,2023, at 2:30PM, it was determined that the laboratory general supervisor did not assure that the manufacturer's instructions were followed by the testing personnel regarding to temperature range for Mycoplasma pneumoniae test. Refer to D5413. -- 2 of 2 --

Summary Statement of Deficiencies 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 quality assessment procedure manual, quality assessment records review (2020-2021) and laboratory general supervisor interview on January 25, 2022 at 10:00 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the following requirements for pre analytic laboratory systems: test request. The findings include: a. Review of the quality assessment procedure manual showed that evaluations to test requisitions must perform each 6 months. b. Review of the quality assessment records showed that the laboratory did not evaluate the test requisitions since April 2020 c. The laboratory general supervisor confirmed on January 25, 2022 at 10:00 AM. that evaluations to test requisitions were not performed since April 2020. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on quality assessment procedures manual, quality assessment records review (2020-2021) and laboratory general supervisor interview on January 25, 2022 at 10:00 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 -- A.M., it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for post-analytic systems. The findings include: a. Review of the quality assessment program showed that evaluations to patient's final test reports and turn around time ( TAT) must be evaluated every six month. b. Review of the quality assessment records showed that the last evaluations to patient's final test reports and turn around time was performed in August 2020. c. The laboratory general supervisor stated on January 25, 2022 at 10: 00 A.M., that evaluations to patient's final test reports and turn around time were not performed since August 2020. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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 Assessment (QA) records review ( 2020-2021 ) and laboratory general supervisor interview on January 25, 2022 at 10:15 A.M, it was determined that laboratory director failed to ensure compliance with quality assessment (QA) requirements. The findings include: 1. Quality Assessment records showed that the laboratory did not evaluate the established Quality Assessment Program to monitor and evaluate the requirements for preanalytic and postanalytic systems. 2. The laboratory general supervisor confirmed on January 25, 2022 at 10:15 A.M , that the laboratory director failed to evaluate the requirements for laboratory preanalytic and postanalytic systems. Refer to D5391 and D5891. -- 2 of 2 --

Summary Statement of Deficiencies D2061 VIROLOGY CFR(s): 493.831(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 ( 2016 to 2018) and laboratory general supervisor interview on May 18, 2018 at 10:30 A.M., it was determined that the laboratory failed to report the proficiency testing results within the time frame established by the program. The finding includes: 1. Proficiency testing records were reviewed from February 2016 to February 2018. 2. The deadline of the third testing event report of virology tests ( Influenza A& B ) was December 23, 2016. 3. The laboratory did not report the third testing event of virology within the time frame established by the Proficiency Testing Program. 4. The laboratory general supervisor confirmed that the laboratory did not report the virology proficiency testing results of the third testing event within the time frame established by the Proficiency Testing Program. 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 ( 2016 to 2018) 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 -- and laboratory general supervisor interview on May 18, 2018 at 10:30 A.M., it was determined that the laboratory failed to report the proficiency testing results within the time frame established by the program. The finding includes: 1. Proficiency testing records were reviewed from February 2016 to February 2018. 2. The deadline of the third testing event report of syphilis serology tests was December 23, 2016. 3. The laboratory did not report the third testing event of syphilis serology within the time frame established by the Proficiency Testing Program. 4. The laboratory general supervisor confirmed that the laboratory did not report the syphilis serology proficiency testing results of the third testing event within the time frame established by the Proficiency Testing Program. D2081 GENERAL IMMUNOLOGY CFR(s): 493.837(d) 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 ( 2016 to 2018) and laboratory general supervisor interview on May 18, 2018 at 10:30 A.M., it was determined that the laboratory failed to report the proficiency testing results within the time frame established by the program. The finding includes: 1. Proficiency testing records were reviewed from February 2016 to February 2018. 2. The deadline of the third testing event report of general immunology tests ( rheumatoid factor and c reactive protein ) was December 23, 2016. 3. The laboratory did not report the third testing event of general immunology within the time frame established by the Proficiency Testing Program. 4. The laboratory general supervisor confirmed that the laboratory did not report the general immunology proficiency testing results of the third testing event within the time frame established by the Proficiency Testing Program. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the 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 verification records review, manufacturer's instructions and laboratory general supervisor interview on May 18,2018 at 11:00 A. M., it was determined that the laboratory failed to perform the calibration verification procedures with at least the frequency recommended by the manufacturer (each six -- 2 of 4 -- months) for the hematology tests performed by the Cell Dyn 3200 system. The findings include: 1. The laboratory uses a Cell Dyn 3200 hematology system for CBC (Complete blood count) patient's tests. 2. The manufacturer's instructions establishes that for the Cell Dyn 3200 system, the calibration verification procedures must be perform each six months. 3. From 2016 to May 2018, the calibration verification records showed that the laboratory did not perform at least every 6 months the calibration verification procedures for the Cell Dyn 1700 hematology system. The calibration verification for Cell Dyn 1700 system was performed on October 2016, March 2017 and January 2018. 4. The laboratory general supervisor confirmed on May 18, 2018 at 11:00 A.M., that the laboratory did not perform at least 6 months the calibration verification procedures for Cell Dyn 3200 system. 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 Program testing records review and laboratory general supervisor interview on May 18, 2018 at 11:00 AM, it was determined that the laboratory director failed to ensure that proficiency testing samples were tested as required under Subpart H requirements. Refer to D2061, D2071 and D2081. 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 calibration verification records review and laboratory general supervisor interview on May 18, 2018 at 11:30 AM, it was determined that laboratory failed to ensure compliance with the requirements for analytic systems. The finding includes: 1. 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 Cell Dyn 3200 system. Refer to D5437. 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: -- 3 of 4 -- Based on hematology calibration verification records review ( 2016 to 2018 ) and laboratory general supervisor interview on May 18, 2018 at 11:30 AM, it was determined that the general supervisor failed to ensure compliance with the requirements for analytic systems. The finding includes: 1. 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 Cell Dyn 3200 system. Refer to D5437. -- 4 of 4 --