Lasalle General Hospital

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted September 16, 2024 through September 18, 2024 at LaSalle General Hospital - CLIA ID # 19D0464876. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and proficiency testing records as well as interview with laboratory personnel, the laboratory failed to perform assessment activities for an unacceptable proficiency testing (PT) result for one (1) of eleven (11) events reviewed. Findings: 1. Review of the laboratory's policy "Proficiency Testing" revealed "When scoring is received, results are reviewed by tech performing PT testing, by the general supervisor and Laboratory Director. Remedial action is taken as necessary." 2. Review of the laboratory's American Proficiency Institute (API) 2024 Chemistry - Core - 2nd Event revealed sample CH-07 AST/SGOT was unacceptable, but the laboratory did not perform any remedial actions. 3. In interview on September 16, 2024 at 5:17 p.m., General Supervisor 2 stated the unacceptable result was missed when the report was evaluated. She confirmed the laboratory did not perform any remedial actions for the unacceptable result identified above. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and proficiency testing records as well as interview with laboratory personnel, the laboratory failed to follow their quality assessment policy for proficiency testing (PT) for one (1) of eleven (11) events reviewed. Findings: 1. Review of the laboratory's policy "Proficiency Testing" revealed "When scoring is received, results are reviewed by tech performing PT testing, by the general supervisor and Laboratory Director. Remedial action is taken as necessary." 2. Review of the laboratory's American Proficiency Institute (API) 2024 Chemistry - Core - 2nd Event revealed sample CH-07 AST/SGOT was unacceptable, but the laboratory did not perform any remedial actions. 3. In interview on September 16, 2024 at 5:17 p.m., General Supervisor 2 stated the unacceptable result was missed when the report was evaluated. She confirmed the laboratory did not perform any remedial actions for the unacceptable result identified above. 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 observation, review of laboratory policies and performance specification verification records, as well as interview with personnel, the laboratory failed to follow their policy for performance specification verification of the Siemens Dimension EXL. Findings: 1. Observation by surveyor during the laboratory tour on September 16, 2024 at 1:20 p.m. revealed the laboratory utilized a Siemens Dimension EXL Serial DR253115 for chemistry testing. 2. Review of the laboratory's policy "Method Performance Specifications" section "Linearity/Reportable Range" revealed "Note: If unable to verify the manufacturer's reportable range for a test, you can only report results to the limits you verified (undiluted)." 3. Review of the laboratory's performance specification verification records revealed the laboratory began patient testing on the analyzer identified above on October 10, 2023 and utilized the manufacturer's analytical measurement range (AMR) and not the AMR verified by the laboratory for analytes to include, but not limited to, the following: a) Ammonia - AMR verified by the laboratory: 0.67 - 656.67 - Manufacturer's AMR: 9.98 - 749.60 b) Triglycerides - AMR verified by the laboratory: 17.0 - 488.0 - Manufacturer's AMR: 15.0 - 500.0 4. In interview on September 17, 2024 at 11:30 a. m., General Supervisor 2 confirmed the laboratory utilized the manufacturer's reportable range and not the reportable range verified by the laboratory. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic -- 2 of 14 -- examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A Certification Survey was performed on January 19, 2021 through January 21, 2021 at LaSalle General Hospital, CLIA ID # 19D0464876. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 observation, maintenance record review and interview with personnel, the laboratory failed to ensure maintenance for the Siemens Sysmex CA 660 Coagulation analyzer was documented per manufacturer requirements. Findings: 1. Observation by surveyor during laboratory tour on January 19, 2021 at 1:32 pm revealed the laboratory utilizes a Siemens Sysmex CA 660 Coagulation analyzer for Prothrombin Time (PT), International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT), and D-Dimer testing. 2. Review of the laboratory's "Sysmex CA-600 Operator Maintenance Checklist" revealed the laboratory performs the following maintenance as required by the manufacturer: a) Quarterly: Perform LED Calibration; Clean DI Water Rinse Bottle with Alcohol b) Yearly: Replace Rinse Filter 3. Review of the laboratory's maintenance logs from January 2019 through December 2020 revealed the laboratory did not document quarterly maintenance for the following three (3) of twenty four (24) months reviewed: a) Clean DI Water Rinse Bottle with Alcohol - June 2019, August 2019, February 2020 4. Further review of the laboratory's maintenance logs from January 2019 through December 2020 revealed the laboratory did not document yearly maintenance for 2019 and 2020. 5. In interview on January 21, 2021 at 10:37 am, the Laboratory Supervisor stated 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 2 -- quarterly maintenance not documented was moved to weekly maintenance but the maintenance logs were not updated to state this change. 6. In further interview on January 21, 2021 at 10:37 am, the Laboratory Supervisor stated that she was unaware that the yearly maintenance was not performed due to thinking the maintenance was performed upon preventive maintenance by the Siemens Field Service Representative. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(6) 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 observation, record review, and interview with personnel, the Laboratory Director failed to ensure that the laboratory performed required maintenance and calibration to ensure acceptable levels of analytical performance. Refer to D5429. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Technical Consultants failed to provide technical and scientific oversight to the laboratory. Refer to D5429. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was conducted May 30, 2018 through June 1, 2018 at LaSalle General Hospital - CLIA ID # 19D0464876. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. 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 the record review and interview with personnel, the laboratory failed to have a complete policies and procedure manual. Findings: 1. Review of the respiratory's records revealed the laboratory did not have written polices and procedures that included: a) Specimen collection: to include the steps in collection of Arterial Blood Gas samples and the testing of samples on the instrument b) Identification of instrument tapes 2. In interview on May 30, 2018 at 3:35 pm, Personnel 10 confirmed the laboratory did not the above policies in place. 3. Review of the laboratory's records revealed the laboratory did not have written policy for the manual checks of the Internationalized Normallized Ratio (INR) calculation. 4. In interview on May 31, 2018 at 11:10 am, Personnel 3 confirmed there was not a policy for manual INR checks. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to perform manual checks of the International Normalized Ratio (INR) calculation. Findings: 1. Review of the policy and procedure manual revealed the laboratory did not have a policy for manual INR checks. 2. Further review of records revealed the laboratory did not have any documentation of manual INR checks being performed. 3. In interview on May 31, 2018 at 11:10 am, Personnel 3 stated the laboratory does not perform manual INR checks. 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 observation, record review, and interview with personnel, the laboratory failed to have a complete Individualized Quality Control Plan (IQCP) to support the reduction in frequency of quality control (QC). Findings: 1. Observation by surveyors during the laboratory tour on May 30, 2018 revealed the laboratory utilized the Opti- Medical CCA-TS2 for blood gas testing. 2. Review of the laboratory's IQCP documents revealed the laboratory did not include the in-house data to support the reduction in frequency of external (liquid) QC to monthly. 3. In interview on May 30, 2018 at 3:45 pm, Personnel 2 and 10 stated the in-house QC data was not included. 4. Review of the laboratory's Task 1 and 3 forms revealed the laboratory performs 147 blood gas tests (to include pH, pCO2, and PO2) annually. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to document temperature changes recorded on the circular temperature charts. Findings: -- 2 of 6 -- 1. Review of the laboratory's "Blood Bank Storage" policy revealed "The refrigerator has a temperature graph that records the temperatures for 7 days. The graphs are changed weekly on Monday morning. They are reviewed each week as well." 2. Review of the Blood Bank's Circular Temperature Charts for 2017 and 2018 revealed the following charts without documentation for temperature changes: a) Date On: 12- 26-16; Date Off: 1-2-17; Temperature recorded on form as 3.6 degrees: The circular chart temperature recorded as -1 degrees for the week. b) Date On: 1-2-17; Date Off: 1-9-17; Temperature recorded on form as 3.5 degrees: The circular chart temperature recorded as 0 degrees for the week. c) Date On: 3-5-18; Date Off: 3-12-18; Temperature recorded on form as 3.5 degrees: The circular chart temperature recorded as -1 degrees for the week. d) Date On: 3-26-18; Date Off: 4-2-18; Temperature recorded on form as 3.6 degrees: The circular chart temperature recorded as 1 degrees for the week. e) Date On: 4-9-18; Date Off: 4-16-18; Temperature recorded on form as 3.6 degrees: The circular chart temperature recorded as -1 degrees for the week. 3. Review of the Quality Assurance log book revealed the laboratory did not document any circular chart temperatures issues. 4. In interview on June 1, 2018 at 9:32 am, Personnel 3 stated she was unaware the pin that records the temperature on the circular charts was at a different temperature. Personnel 3 further stated she checks for variations in temperature but does not check the actual temperature on the circular chart. 5. In further interview on June 1, 2018, Personnel 3 confirmed the laboratory did not document the temperature changes recorded on the circular charts. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of