Laboratorio Clinico San Antonio

Summary Statement of Deficiencies 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 records review ( year 2022-2023 ) and interview with the laboratory director on August 2, 2023 at 12: 15 P.M, it was determined that the laboratory failed to meet the requirements in the subspecialty of General Immunology. The finding includes: 1. The laboratory did not include an external positive and a negative control material each day of patient testing. Refer to D5449 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 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 -- 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 routine chemistry calibration verification records review (year 2022-2023) and interview with the laboratory director on August 24, 2023 at 10:20 A.M., it was determined that the laboratory did not perform , at least every 6 months, the calibration verification procedures for the electrolytes tests processed by the Dimension ExL 200 system. The findings include: 1. The laboratory used the Dimension ExL 200 system to perform routine electrolytes tests. 2. The laboratory performed the electrolytes calibration verification procedures on 12/2021/ 6/2022 and 7/2023. 3. Review of routine chemistry calibration verification records showed that the laboratory did not perform the electrolytes calibration verification procedure on December 2022. ( review on August 24, 2023 at 10:25 A.M.) 4. The laboratory processed and reported from December 2022 to June 2023 eightysix electrolytes patient samples. ( review on August 24, 2023 at 10:30 A.M.) 5. The laboratory director confirmed on August 24, 2023 at 10:35 A.M., that the laboratory failed to perform , at least every 6 months, the calibration verification procedures for electrolyte tests. 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 General Immunology (Mycoplasma pneumoniae test) quality control records review (years 2022-2023) and laboratory director interview on August 24, 2023 at 11:10 A.M., it was determined that the laboratory did not include an external positive and negative control material each day of Mycoplasma pneumoniae patient testing. The findings include: 1. General Immunology (Mycoplasma pneumoniae test) quality control records were review on August 24, 2023 at 11: 10 A.M., from October 2022 to August 2023. 2. Review of Mycoplasma pneumoniae quality control and patient results record showed that the laboratory did not include any control material each day of patient testing since October 2022. ( review on August 24, 2023 at 11: 15 A.M. ) 3. The laboratory director confirmed on August 24, 2023 at 11: 25 A.M., that the laboratory failed to include a negative and positive control material each day of testing when performed Mycoplasma pneumonia test. 4. The laboratory did not include any control material, when 191 out 191 patient specimen were processed and since October 2022. ( review on August 24, 2023 at 11: 25 A.M. ) -- 2 of 3 -- D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of General Inmunology quality control records ( year 2022-2023 ) , it was determined that the laboratory director failed to fulfill her responsibilities with the Mycoplasma pneumoniae analytic requirements. Refer to D6020. 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 routine chemistry and Mycoplasma pneumoniae quality control records review ( 2022-2023 ) , and interview with the laboratory director on August 24, 2023 at 11:45 A.M., it was determined that the laboratory director failed to follow quality control procedures for the routine chemistry tests and Mycoplasma pneumoniae tests. Refer to D5439 and D 5449. -- 3 of 3 --

Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on routine chemistry quality control records review ( 2018-2019) and interview with the laboratory director on September 13, 2019, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for routine chemistry subspecialty . The findings include: 1. The laboratory failed to follow manufacturer's instructions when patient specimens were tested for routine chemistry tests by the Dimension Xpand system. Refer to D 5405. 2. The laboratory failed to verify the performance specifications of the Dimension Xpand routine chemistry system when the laboratory was relocated on May 15, 2019. Refer to D 5421. 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: Based on manufacturer's instructions, routine chemistry and endocrinology quality 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 records review in 2017-2018 and laboratory director interview at 10:30 a.m. on September 13, 2019, it was determined that the laboratory failed to follow manufacturer's instructions when patient specimens were tested for routine chemistry tests by the Dimension Xpand system. The findings include: 1. The laboratory uses Dimension Xpand system to perform routine chemistry and endocrinology patient tests. 2. The manufacturer establishes that two levels of control material ( normal and high) must be included each day of testing. 3. Review of routine chemistry quality control records from January 2018 to September 2019, showed that the laboratory did not include the two levels of controls from January 2, 2019 to February 7, 2019. 4. The laboratory processed and reported 8,854 routine chemistry analytes during those days. 5. The laboratory director confirmed that the laboratory failed to follow manufacturer's instructions ( regarding testing of control materials ) when patient specimens were tested for routine chemistry by the Dimension Xpand system. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: 1. Based on lack of hematology performance specifications records and laboratory director interview at 10:00 a.m. on September 13, 2019, it was determined that the laboratory failed to verify the performance specifications of the Cell Dyn 3200 hematology system when the laboratory was relocated on May 15, 2019. The findings include: a. The laboratory was relocated on May 15, 2019. There were not records of the performance verification of specifications. b. The laboratory director confirmed on September 13, 2019 at 10:00 A.M. that the laboratory failed to perform the performance specifications of the Cell Dyn 3200 system prior to begin to test patient samples for Complete Blood Count hematology tests. c. The laboratory processed and reported 1,084 Complete Blood Count (CBC) since May 15, 2019. 2. Based on lack of routine chemistry performance specifications records and laboratory director interview at 10:00 a.m. on September 13, 2019, it was determined that the laboratory failed to verify the performance specifications of the Dimension Xpand system when the laboratory was relocated on May 15, 2019. The findings include: a. The laboratory was relocated on May 15, 2019. There were not records of the performance verification of specifications. b. The laboratory director confirmed on September 13, 2019 at 10:00 A.M. that the laboratory failed to perform the performance specifications of the Dimension Xpand system prior to begin to test patient samples for routine chemistry tests. c. The laboratory processed and reported 14,288 routine chemistry analytes samples since May 15, 2019. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance -- 2 of 3 -- with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on hematology and routine chemistry performance specifications records review ( 2019) and laboratory director interview on September 13, 2019 at 11:30 AM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory analytical system requirements. The finding includes: 1. The laboratory director did not comply with the requirement for analytical systems requirements. Refer to D5405, D5421. 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 hematology and routine chemistry lack performance specifications records ( 2019 ) and laboratory director interview on September 13, 2019 at 11:30 A.M. it was determined that laboratory director failed to ensure compliance with the requirements for hematology and routine chemistry analytic systems. Refer to D5405 and D5421. -- 3 of 3 --