Lab Clinico Hospital General Castaner

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Hospital General Castaner, Inc on May 13, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the recertification CLIA survey ending on May 13, 2025. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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: Based on review of routine chemistry performance specifications records ( September 2024 ) and laboratory director interview on May 13, 2025 at 11:15 A.M., it was determined that the laboratory failed to complete the evaluation of the performance specifications of the new routine chemistry and special tests system. The findings include: 1. The laboratory acquired on September 2024 a new system to perform routine chemistry and special tests. ( Atellica CI 1900 ) 2. The performance specifications records showed that the laboratory did not verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. 3. The laboratory director confirmed on May 13, 2025 at 11:15 A.M. , that the laboratory did not verify if the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population prior to begin testing patient's samples. 4. The laboratory processed and reported approximately 74,649 routine 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 -- chemistry tests and 5,152 special tests performed by Atellica CI 1900 since September 2024. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 manufacturer's specifications, ABL 80 Flex routine procedures log review (years 2025) and laboratory director interview on May 13, 2025, at 11:57 A.M., it was determined that the laboratory failed to perform and document the preventive maintenance as required by manufacturer of the ABL 80 Flex blood gas analyzer, when processed and reported 35 out of 35 arterial blood gas from January 1, 2025 to May 13, 2025. The findings include: 1. The laboratory uses ABL 80 Flex system to perform arterial blood gas patient samples since May 2024. 2. The manufacturer's specifications establishes: clean the screen & exterior surface daily. 3. Review of ABL 80 Flex routine procedures log January 2025 to May 13, 2025, showed that the laboratory did not perform nor document the clean the screen & exterior surface daily. 4. The laboratory did not perform nor document the daily preventive maintenance the following days that performed patient samples: 1/17/25, 1/21/25, 1/23/25, 1/24/25, 2/4 /25, 2/5/25, 2/8/25, 2/11/25, 2/12/25, 2/14/25, 2/15/25, 2/19/25, 2/25/25, 3/2/25, 3/11 /25, 3/15/25, 3/16/25, 3/17/25, 4/2/25, 4/7/25, 4/12/25, 4/14/25, 4/15/25, 4/19/25, 4/28 /25, 5/5/25, 5/6/25 and 5/7/25. 4. The laboratory processed and reported 35 out of 35 arterial blood gas those days. 5. The laboratory director confirmed on May 13 2025, at 1:30 P.M., that the laboratory failed to follow the manufacturer's specifications for the preventive maintenance of ABL 80 system. 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 arterial blood gas calibration verification records review (years 2025), and -- 2 of 3 -- laboratory director interview on May 13, 2025, at 11:00 AM , it was determined that the laboratory did not perform , at least every 6 months, the calibration verification procedures for the arterial blood gas tests processed by the ABL 80 system ,when processed and reported 27 out of 27 arterial blood gas tests from November 2024 to February 27, 2025. The findings include: 1. The laboratory began to use the ABL 80 system to perform arterial blood gas tests since May 2024. 2. Review of calibration verification records showed that the laboratory did not perform , at least every 6 months, the calibration verification procedures for the arterial blood gas tests processed by the ABL 80 system. The records showed that calibration verification procedures were not performed on November 2024. 3. The laboratory director stated on May 13, 2025, at 11:00 AM, that the calibration verification was performed on February 27, 2025. 4. The laboratory processed and reported 27 out of 27 arterial blood gas analytes from November 2024 to February 2025. 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 routine chemistry and arterial blood gases quality control records review ( years 2024-2025 ) and laboratory director interview on May 13, 2025 at 2:00P.M., it was determined that laboratory failed to ensure compliance with the requirements for analytic systems. Refer to D5421, D5429 and D5439. 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 routine chemistry performance specifications records, arterial blood gases calibration verification procedures, manufacturer's specifications records review (2024-2025) and laboratory general supervisor interview on May 13, 2025 at 2:00 P. M., it was determined that the general supervisor failed to follow quality control procedures. Refer to D5421, D5429 and D5439. -- 3 of 3 --

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on lack of procedure manual, quality control records, validation test and laboratory testing personnel interview on April 24, 2023 at 1:30 PM; it was determined that the laboratory failed to meet requirements for analytic systems. Refer to D 5401, D5421, D5445. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on lack of procedures manuals, quality control records review and testing personnel interview on April 24, 2023 at 11:50 AM; it was determined that the laboratory failed to have the procedures manuals for the Blood Gas sub-specialty since July 2021. The findings include: 1. On April 24, 2023 at 11: 28 AM, 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 -- procedure manuals was requested. The procedure manual was not available at the time of inspection. The laboratory did not have available a procedures manual that include the requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection. 2. On April 24, 2023 at 11:30 AM, the quality control showed that the laboratory performed the Blood Gas test in the laboratory. 3. On April 24, 2023 at 11:50 AM, the testing personnel confirmed that the laboratory failed to have the procedures manuals for the Blood Gas sub-specialty since July 2021. 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: Based on Blood Gas test on Stat profile prime (Nova) analyzer validation and laboratory testing personnel interview on April 24, 2023 at 11:45 AM, it was determined that the laboratory director fail to reviewed or approved the validation of the new analyzer since July 2021. The laboratory process and report 391 out 391 of patient specimens from July 21, 2021 The findings include: 1. On April 24, 2023 at 11: 38 AM the validation of the new analyzer for Blood Gas was requested and showed that the laboratory director did not reviewed or approved the validation of the Stat profile prime since July 2021. The laboratory began to process and report patient specimens since July 2021. 2. On April 24, 2023 at 11:45 AM the testing personnel confirmed that the laboratory director fail to reviewed or approved the validation of the new analyzer since July 2021. The laboratory process and report 391 out 391 of patient specimens from July 21, 2021 to April 24, 2023. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Blood Gas manufacturer's instruction, quality control records (year 2022) and laboratory testing personnel interview on April 24, 2023 at 11:30 AM, it was determined that the laboratory failed to include every eight (8) hours at least one level of control material when 70 out of 70 patient specimens were tested for Blood Gas -- 2 of 3 -- test from August 1, 2022 to December 12, 2022. The findings include: a. On April 24, 2023 at 11:00 AM, the Blood Gas manufacturer's instructions was reviewed and states that during each eight (8) hours of testing, analyze one level of control. b. On April 24, 2023, at 11:15 AM, the Blood Gas quality control records was reviewed and showed that the laboratory run three (3) level of control at seven (7) AM and two (2) level at seven (7) PM. c. The laboratory testing personnel confirmed on April 24, 2017 at 11:30 AM, that the laboratory did not include every eight (8) hours at least one level of control material when 70 out of 70 patient specimens were tested for Blood Gas test from August 1, 2022 to December 12, 2022. 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: Based on lack of procedure manuals, quality control records and validation test and laboratory testing personnel interview onApril 24, 2023, at 2:00 PM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory analytic systems. Refer to D6093 and D6095. 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 Blood Gas subspecialty quality control records reviewed (year 2022) and interview with the laboratory testing personnel; it was determined that the laboratory director failed to ensure that the quality control was established the same manner as the manufacturer's instructions. Refer to D5417 D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on lack of procedure manual, validation reviewed and laboratory testing personnel interview on April 24, 2023 at 2:00 PM; it was determined that the laboratory director failed to established and maintenance the procedure manual for the Blood Gas subspecialty. Refer to D 5401 and D 5421. -- 3 of 3 --

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 bacteriology quality control records review and interview with the laboratory technical on April 9, 2019 at 11:15 AM., it was determined that the laboratory did not have specific written instructions for blood cultures and also did not ensure that the testing personnel followed the written instructions for blood culture procedures. Refer to D5401. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: 1. Based on review of the bacteriology written procedures manual, hand written instructions for blood cultures, blood culture worksheet review and interview with the laboratory technical supervisor and testing personnel on April 9, 2019 at 11:15 AM, it was found that three different non-automated blood cultures written instructions were available to the testing personnel. The findings include: a. The laboratory technical supervisor state on April 9, 2019 at 11:15 AM stated that the Bac- T- Alert system 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 -- was out of service since March 21, 2019. She also stated that in the meanwhile they performed a non-automated incubation process. b. Three different written instructions were reviewed: one included in the bacteriology procedure manual and two others posted in the bacteriology area. c. The written instruction included in the procedure manual showed the following: * To incubate the bottles at 37 C for eight days * At 24 hours sub-culture the aerobic and anaerobic bottles to blood and chocolate agar * AT 48 hours observed the culture plates and performed a preliminary report. * At the seventh days sub-culture again aerobic and anaerobic bottles to blood and chocolate agar d. One of the hand written instruction observed at the bacteriology area showed the following: *At 24 hours cub-culture the aerobic and anaerobic bottles to blood, chocolate and Mac Conkey agar. At the next 24 observed the aerobic sub-cultures At 48 hours observed the anaerobic sub-cultures * At the seventh day sub-culture the anaerobic bottles again and observed within 24 hours. * AT the eighth day sub-culture the aerobic bottle and observed at 24 hours. e. The other hand written instructions showed the following: "Instrument out of service" Protocol: *Aerobic- within 24 hours perform a gram satin and sub-culture to blood, chocolate and Mac Conkey agar. *Anaerobic - The same procedure within 48 hours * For the next 10 days check for turbidity. * At the tenth day, sub-culture to blood, chocolate and Mac Conkey agar. f. The technical supervisor stated that the instructions given by her were the third ones (Item #5), however the testing personnel # 6 stated that the instructions that were being followed by all the testing personnel were the second ones (Item # 4), the instructions were written by testing personnel # 1. 2. Based on interview with the laboratory technical supervisor, the testing personnel # 6 and review of the worksheets designed for blood cultures documentation and observation, it was found that the testing personnel did not follow the written instructions. The findings include: a. Testing personnel # 6 stated on March 9, 2019 at 11:50 AM, that the instructions that were being followed by all the testing personnel were the following: *At 24 hours cub- culture the aerobic and anaerobic bottles to blood, chocolate and Mac Conkey agar. * At the next 24 observed the aerobic sub-cultures * At 48 hours observed the anaerobic sub-cultures * At the seventh day sub-culture the anaerobic bottles again and observed within 48 hours. * At the eighth day sub-culture the aerobic bottle and observed at 24 hours. b. During interview the technical supervisor also stated that since March 21, 2019 a new worksheet was designed. Review of the worksheet showed that for blood cultures the following procedures must be documented: * At 24 hours- subculture in blood agar the aerobic and anaerobic bottle, reading of the aerobic plate in the next 24 hours and the anaerobic one at 48 hours. Document a preliminary report. * At the seventh day sub-culture the anaerobic bottle - read at 48 hours * At the eighth day sub- culture of the aerobic bottle- read at 24 hours c. Review of patient's blood cultures worksheets showed the following: i. Patient identification - 35492-sample collection March 31, 2019. Reported as no growth as on April 8, 2019. As per written instructions the final test report must be performed on April 9, 2019. Not on April 8, 2018. ii. Patient identification - 05803-sample collection March 28, 2019. Review of the worksheets showed that the preliminary report was not performed. d. At 12:20 PM, inside the bacteriology incubator three sets of blood cultures bottles were observed. The sample collection date was April 7, 2019. By the day survey (March 9, 2019) no sub-cultures were performed. e. The technical supervisor stated that she was not aware of the situation. 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 -- 2 of 4 -- with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on blood cultures written instructions and laboratory technical supervisor interview on April 9, 2019 at 12:15 PM, it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the blood cultures analytic procedures. Refer to D6087 and D6106. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of blood cultures worksheets and interview with the technical supervisor, it was determined that the laboratory director did not make sure that the blood cultures testing procedures were followed by the testing personnel. The findings include: a. The testing personnel completed a blood culture procedure before the established due date of nine days after sample collection. b. The testing personnel did not followed written instructions regarding sub-cultures procedures. Refer to D 5401 - finding #2 D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on bacteriology manual, hand written instructions for blood cultures review and interview with the technical supervisor on April 9, 2019 at 11:15 AM, it was found that the laboratory director did not sign not approved the written procedures for bacteriology blood cultures. The findings include: a. At the date of survey three different written procedures were available for blood cultures. b. None of the procedures was approved by the laboratory director. c. The technical supervisor stated that the procedure included the bacteriology procedures manual was under revision, and the other two were written by her and by testing personnel #1. Refer to D 5401- Finding #1 D6175 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(1) Each individual performing high complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on review of the written instructions that were being used by the testing -- 3 of 4 -- personnel for blood cultures and interview with the laboratory technical supervisor on April 9, 2019 at 11:15 AM, it was found that the testing personnel did not follow the written instructions when they performed patient's blood cultures. Refer to D5401, finding #2. -- 4 of 4 --