Hosp Metropolitano San German

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA Recertification survey at the Hospital de la Concepcion San German Pueblo on January 21, 2026. 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 January 21, 2026. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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 quality control records review (years 2018-2019) and laboratory general supervisor interview at 9:00 AM on January 16, 2020, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for body fluids cell counts. Refer to D 5543. 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 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 -- 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 quality control records review (years 2018-2019) and laboratory director general supervisor interview at 11:00 AM on January 16, 2020, it was determined that the laboratory failed to perform at least every 6 months the calibration verification procedures for the Arterial Blood Gases (pH, pCO2, P02) tests processed by the Cobas b221 system. The findings include: 1. The laboratory uses a Cobas b221 system for Arterial Blood Gases (pH, pCO2, P02) tests. 2. From January 2018 to January 2020, the records showed that the laboratory did not perform at least every 6 months the calibration verification procedures for the Arterial Blood Gases (pH, pCO2, P02) tests processed by the Cobas b221 system. 3. The laboratory processed and reported three hundred seventy six (3,076) Arterial Blood Gases (pH, pCO2, P02) patient's samples tests those days. 3. The laboratory general supervisor stated on January 16, 2020, that the laboratory did not perform at least 6 months the calibration verification procedures for Arterial Blood Gases (pH, pCO2, P02) tests processed by the Cobas b221 system. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on hematology body fluids count testing records review (years 2018-2019) , lack of quality control records and laboratory general superivsor interview on January 16, 2020 at 9:00 AM, it was determined that the laboratory failed to include one control material each 8 hours of operation when manual body fluids (ascitic, pleural and Cerebro Spinal fluids) cell counts were performed by hemocytometer. The findings include: 1. The records showed that the laboratory performed manual cell counts (ascitic, pleural and Cerebro Spinal fluids) by the hemocytometer. 2. From January 2018 to January 2020, the records showed that the laboratory did not include one control material each 8 hours of operation when 13 out 13 body fluids patients specimens were processed for (ascitic, pleural and Cerebro Spinal fluids) cells counts by the hemocytometer. 3. The laboratory processed and reported thirteen (13) body fluids patients specimens were processed for (ascitic = 6, pleural = 4 and Cerebro Spinal fluids = 3) cells counts. 4. The laboratory general supervisor confirmed on January 16, 2020, that the testing record not show any documentation of the control procedure. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 4 -- 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: Based on hematology and routine chemistry quality control records review (years 2018-2019) and laboratory general supervisor interview at 11:30 AM on January 16, 2020, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control and quality assessment 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 hematology and routine chemistry quality control records review (years 2018-2019) and laboratory general supervisor interview at 11:30 AM on January 16, 2020, it was found that the laboratory director did not assure that quality control procedures were follow related to calibration verification for Cobas b221 (ABG) and any control material when cell counts were performed by hemocytometer. The findings include: 1. The laboratory failed to perform at least every 6 months the calibration verification procedures for the Arterial Blood Gases (pH, pCO2, P02) tests processed by the Cobas b221 system. Refer to D5439. 2. The laboratory failed to include one control material each 8 hours of operation when manual body fluids (ascitic, pleural and Cerebro Spinal fluids) cell counts were performed by hemocytometer. Refer to D5543. 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 and routine chemistry quality control records review (years 2018-2019) and laboratory general supervisor interview at 11:30 AM on Janjuary 16, 2020, it was determined that the general supervisor did not assure that quality control procedures were followed by the testing personnel. Refer to D5439 and D5543. 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. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on hematology and routine chemistry quality control records review (years 2018-2019) and laboratory geneal supervisor interview on January 16, 2020 at 11:30 AM, it was determined that testing personnel failed to follow quality control procedures. Refer to D5439 and D5543. -- 4 of 4 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on hematology preventive maintenance records review from January 2016 to January 23, 2018 and laboratory director interview on January 23, 2018 at 10:55 AM, it was determined that the laboratory failed to follow manufacturer's instructions for the preventive maintenance of Sysmex 1800i and Sysmex XS 1000i analyzer. The findings include: 1. The laboratory did not perform the monthly preventive maintenance of the Sysmex 1800i analyzer from February 2017 to December 2017 and the Sysmex XS 1000i analyzer on January 2017, February 2017, April 2017, June 2017 to December 2017. 2. The testing personnel and laboratory director confirmed on January 23, 2018, that the laboratory did not perform and document the preventive maintenance of Sysmex 1000i and Sysmex XS 1000i analyzer those months. 3. The laboratory perform 160,627 patients tests from January 1, 2017 to December 31, 2017. 4. This deficiency was cited on January 27, 2016 survey. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. 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 -- This STANDARD is not met as evidenced by: Based on urinalysis quality control records review in 2016-2017 and laboratory director interview on January 23, 2018 at 11:35 AM, it was determined that the laboratory failed to follow the written policies to evaluate twice a year the relationship of the test urinalysis performed by the systems ARKRAY Au4050 and Clinitek Advantus. The findings include: 1. The laboratory performed urinalysis by the systems ARKRAY Au4050 and Clinitek Advantus. 2. Quality controls records were reviewed since January 2016. 3. The laboratory director stated on January 23, 2018 that the laboratory written procedures established to evaluate each six months the relationship between two system that perform the same test. 4. The laboratory did not perform the comparison of the urinalysis tests by two different systems since 2016. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on quality assessment (QA) records review in 2016-2017 and laboratory director interview on January 23, 2018 at 11:35 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for analytic systems. The finding includes: 1. The laboratory failed to follow the written policies to evaluate twice a year the relationship of the test urinalysis performed by the systems ARKRAY Au4050 and Clinitek Advantus.. Refer to D5775. 2. The laboratory failed to follow manufacturer's instructions for the preventive maintenance of Sysmex 1800i and Sysmex XS 1000i analyzer. Refer to D5429. 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 urinalysis quality control records review in 2016-2017 and laboratory director interview at 11:35 AM on January 23, 2018, it was determined that laboratory director failed to ensure compliance with the requirements for analytic systems. The finding includes: 1. The laboratory failed to follow the written policies to evaluate twice a year the relationship of the test urinalysis performed by the systems ARKRAY Au4050 and Clinitek Advantus. Refer to D5775. 2. The laboratory failed to follow the manufacturer's instructions for the preventive maintenance of Sysmex 1800i and Sysmex XS 1000i analyzer. Refer to D5429. -- 2 of 4 -- D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records review in 2016-2017 and laboratory director interview on January 23, 2018 at 11:35 AM, it was determined that laboratory director failed to ensure compliance with quality assessment requirements. The finding includes: 1. The laboratory failed to follow the written policies to evaluate twice a year the relationship of the test urinalysis performed by the systems ARKRAY Au4050 and Clinitek Advantus. Refer to D5791. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on personnel records review and laboratory director interview on January 23, 2018 at 11:48 AM, it was determined that the laboratory failed to follow the written procedures to monitor and ensure the competency evaluations of the Clinical Consultant. The finding includes: 1. The personnel records showed that the laboratory director did not evaluated annually the competence of the Clinical Consultant. The last competence in records was performed on January 1, 2015. 2. This deficiency was cited on January 27, 2016 survey. 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: 1. Based on urinalysis quality control records review in 2016-2017 and laboratory director interview on January 23, 2018 at 11:35 AM, it was determined that testing personnel failed to follow quality control procedures. The finding includes: a. The laboratory failed to follow the written policies to evaluate twice a year the relationship of the test urinalysis performed by the systems ARKRAY Au4050 and Clinitek -- 3 of 4 -- Advantus. Refer to D5775. 2. Based on hematology preventive maintenance records review from January 2016 to December 2017, laboratory testing personnel and laboratory director interview on January 23, 2018 at 10:58 AM, it was determined that the testing personnel failed to follow the preventive maintenance of the hematology analyzer (Sysmex 1800i and Sysmex XS 1000i). The finding includes: a. The laboratory failed to follow the manufacturer's instructions for the preventive maintenance of Sysmex 1800i and Sysmex XS 1000i analyzer. Refer to D5429. -- 4 of 4 --