Bates County Memorial Hospital

Summary Statement of Deficiencies D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: Based on review of gram stain quality control (QC) records, and interview technical supervisor #2, the laboratory failed to document positive and negative reactivity each week of use for gram stains for 5 of 63 weeks in 2023 and to date March 12, 2024. Findings: 1. Review of gram stain QC showed no gram stain QC performed the week of March 27, 2023, April 4, 2023, August 8, 2023, February 6, 2024 and February 20, 2024. 2. Interview with technical supervisor #2 on March 12, 2024 at 11:00 AM confirmed the laboratory failed to document positive and negative reactivity each week of use for gram stains. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the observation of laboratory pipettes, the lack of function check documentation and interview with the technical supervisor (TS) #2, the laboratory failed to perform and document function checks to verify the accuracy of eight of eight laboratory pipettes for 2020, 2021 and to date June 14, 2022. Findings: 1. Observation of laboratory pipettes showed the last function check for the Eppendorf 10-100 pipette, MLA- 50, MLA-75, MLA-100, MLA-200, MLA-500, MLA-1000 pipettes and a Thermo Finnpipette 100-1000 pipette was performed in September 2019. 2. The laboratory could not provide documentation showing that the pipettes were evaluated in 2020, 2021, or to date June 14, 2022. 3. Interview with the TS #2 on June 14, 2022 at 1:00 PM confirmed the laboratory failed to perform and document function checks to verify the accuracy of laboratory pipettes in use for patient testing. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- 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 -- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of iStat blood gas EG7+ quality control (QC) records, and interview with the technical supervisor (TS) #2, the laboratory failed to verify the QC criteria in LIS matched QC package insert for control material providing quantitative results. Findings: 1. Interview with TS #2 stated the laboratory used QC package insert ranges for the iStat blood gases. 2. Review of the iStat TriControls Level 1 Lot # 391145 package insert showed: Na: 121-129 mmol/L iCa: .77-.93 mmol/L PCO2: 55-77 mmHg PO2: 69-99 mmHg HCT: 20-26 QC values for Level 1 in laboratory LIS: Na: 121-130 mmol/L iCa: .76-.92 mmol/L PCO2: 54.3-69.3 mmHg PO2: 70-100 mmHg HCT: 19-25 3. Review of the iStat TriControls Level 3 Lot # 321141 package insert showed: PCO2: 16.1-28.7 mmHg PO2: 124-168 mmHg QC values for Level 3 in laboratory LIS: PCO2: 16-28.6 mmHg PO2: 126-170 mmHg 4. Interview with TS #2 on June 14, 2022 at 1:30 PM confirmed the laboratory failed to verify QC criteria in LIS matched QC package insert for acceptability of control materials providing quantitative results. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the blood bank procedure manual, quality control (QC) / patient records for 2019 and to date January 7, 2020 and interview with technical supervisor #1, the laboratory failed to follow the procedure manual for recording reagent lot number (#) information in the blood bank log book. Findings: 1. The blood bank procedure manual states," Reagent lot # and expiration date should be recorded in the blood bank log book along with the results." 2. The laboratory did not document /record reagent lot # for QC and patient use in the blood bank log book from May 2019 through January 7, 2020. 3. Interview with technical supervisor #1 on January 7, 2020 at 11:50 AM confirmed the laboratory failed to document reagent lot # in the blood bank log as stated in the procedure manual. 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 2 -- This STANDARD is not met as evidenced by: Based on the lack of instrument comparison documentation for two BD Bactec FX 40 blood culture instruments and interview with technical supervisor #1, the laboratory failed to evaluate and define a relationship between test results using the same instruments twice a year for 2018, 2019 and to date January 7, 2020. Findings: 1. No documentation was available to show the laboratory evaluated and define a relationship between test results for the BD Bactec FX 40 instrument (A) and BD Bactec FX 40 instrument (C) twice a year for 2018, 2019 and to date January 7, 2020. 2. Interview with technical supervisor #1 on January 7, 2020 at 11:50 AM confirmed the laboratory failed to have a system that twice a year evaluated and defined a relationship between the two blood culture instruments performing the same tests. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of blood gas competencies and interview with technical supervisor #1 the technical consultant failed to evaluate and document six of six annual blood gas competencies in 2018, 2019 and three of three initial blood gas competencies in 2019. Findings: 1. Review of 2018 annual competencies showed the technical consultant failed to evaluate and document competency for testing personnel #1, #2, #3, #5, #6 and #9. 2. . Review of 2019 annual competencies showed the technical consultant failed to evaluate and document competency for testing personnel #1, #2, #3, #5, #6 and #9. 3. Review of 2019 initial competencies showed the technical consultant failed to evaluate and document initial competency for testing personnel #4, #7 and #8. 3. Interview with the technical supervisor #1 on January 7, 2020 at 11:00 AM confirmed the technical consultant failed to evaluate and document blood gas competency in 2018 and 2019. -- 2 of 2 --

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policies and interview with testing personnel #1 on January 3, 2018 at 12:00 PM confirmed, the laboratory failed to have a written policy available for specimen processing, specimen acceptability and rejection for chemistry and coagulation testing. 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 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)