Beatrice Community Hospital & Health Center

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: I. Based on surveyor review of Human Chorionic Gonadotropin (HCG), serum quality control (QC) records, lack of Individualized Quality Control Plan (IQCP), and interview with the laboratory manager, the laboratory failed to perform quality control (QC) each day of patient testing Human Chorionic Gonadotropin (HCG), serum from 9/25/2025 - 2/3/2026. Findings: 1. Review of HCG, serum QC records from 9/25 /2025 - 2/3/2026, revealed QC performed with each new lot and new shipment. 2. Interview with the laboratory manager on 2/3/2026 at 1:36 PM, confirmed the laboratory did not have an IQCP in place for HCG, serum. 3. Interview with the laboratory manager on 2/3/2026 at 1:36 PM, confirmed the laboratory tested 477 patients for HCG, serum in 2025. II. Based on surveyor review of Clinitek Advantus Urinalysis quality control (QC) records, Clinitek Advantus Operators's Guide, interview with testing personnel #2 (TP #2), as indicated on the CMS 209 form, and the laboratory's list of tests performed, the laboratory failed to perform quality control (QC) each day of patient testing urinalysis on the Clinitek Advantus from 8/20/2025 - 12/15/2025. Findings: 1. Review of Clinitek Advantus Urinalysis QC records from 8 /20/2025 - 12/15/2025, revealed QC performed with each new bottle. 2. Review of 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 -- Clinitek Advantus Operator's Guide indicate the following: "Run controls under the following conditions: at the start of the days run, when using a new bottle of reagent strips, whenever test results are in doubt, when training new operators". 3. Interview with TP #2 on 2/4/2026 at 11:11 AM, confirmed the laboratory performed QC with each new bottle but not every day of testing. 4. Review of the laboratory's list of tests performed revealed the laboratory tested 5666 patients for urinalysis on the Clinitek Advantus in 2025. III. Based on surveyor review of StatSensor creatinine quality control (QC) records, laboratory's StatSensor Creatinine Meter Policy, and interview with the laboratory manager, the laboratory failed to perform quality control (QC) each day of patient testing creatinine on the StatSensor from 2/17/2025 - 2/4/2026. Findings: 1. Review of StatSensor creatinine QC records from 2/17/2025 - 2/4/2026, revealed QC performed monthly. 2. Review of the laboratory's StatSensor Creatinine Meter Policy indicate the following: "2 levels of control will be run every 24 hrs of patient testing." 3. Interview with the laboratory manager on 2/4/2026 at 11:15 AM, confirmed the laboratory did not run 2 levels of control every 24 hours of patient testing. -- 2 of 2 --

Summary Statement of Deficiencies 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 proficiency testing documents, review of point of care - moderate complexity creatinine test records, lack of documentation, and interview with the laboratory manager, the laboratory failed to have competency assessment on thirteen moderate complexity testing personnel, performing point of care - moderate complexity creatinine testing, from 1/1/2022 - 1/17/2024. Findings are: 1. Review of proficiency testing documentation revealed the laboratory performs point of care - moderate complexity creatinine testing. 2. Review of point of care - moderate complexity creatinine testing records revealed thirteen testing personnel performed creatinine testing from January 2022 through date of the survey. 3. No competency assessment for thirteen moderate complexity testing personnel was presented at time of survey. 4. Interview on 1/17/2023 at 3:00 PM with the laboratory manager confirmed no documentation was available at time of survey. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: 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 -- Based on lack of documentation the laboratory failed to have proof of education on thirteen moderate complexity testing personnel, as listed on the CMS-209 (identifiers TP #1 - TP #13), performing point of care - moderate complexity creatinine testing from 1/1/2022 - 1/17/2024. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of proficiency testing documents, review of point of care - moderate complexity creatinine test records, lack of documentation, and interview with the laboratory manager, the laboratory failed to have proof of education on thirteen moderate complexity testing personnel, as listed on the CMS-209 (identifiers TP #1 - TP #13), performing point of care - moderate complexity creatinine testing from 1/1 /2022 - 1/17/2024. Findings are: 1. Review of proficiency testing documentation revealed the laboratory performs point of care - moderate complexity creatinine testing. 2. Review of point of care - moderate complexity creatinine testing records revealed thirteen testing personnel performed creatinine testing from January 2022 through date of the survey. 3. No proof of education for thirteen moderate complexity testing personnel was presented at time of survey. 4. Interview on 1/17/2023 at 3:00 PM with the laboratory manager confirmed no documentation was available at time of survey. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an off-site proficiency testing desk review of the laboratory's 2022 American Proficiency Institute proficiency testing (PT) records and a telephone interview with the laboratory manager on February 6, 2023, it was determined the laboratory failed to successfully participate in proficiency testing for the analyte cell identification/white blood cell differential. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing for 2022, the laboratory's graded Proficiency Testing results from American Proficiency Institute, and a phone interview with the laboratory manager the laboratory had an unsatisfactory performance for the analyte Cell Identification/White Blood Cell Differential. Findings are: 1. 2022 first event, analyte - Cell Identification/White Blood Cell Differential, score 20%. 2. 2022 third event, analyte - Cell Identification/White Blood Cell Differential, score 68%. 3. Phone interview with the laboratory manager on February 6, 2023 at 10:45 AM confirmed the laboratory had an unsatisfactory performance for the analyte Cell Identification/White Blood Cell Differential. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an off-site desk review of the laboratory's 2022 American Proficiency Institute proficiency testing (PT) records and a telephone interview with the laboratory manager on November 28, 2022, it was determined the laboratory failed to successfully participate in proficiency testing for the analyte D(Rho). Refer to D2162. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk review, the laboratory's graded PT results from American Proficiency Institute (API), and a phone interview with the laboratory manager, the laboratory failed to achieve satisfactory performance for the D(Rho) analyte in two consecutive testing events. Findings are: 1. The laboratory obtained an unsatisfactory score of 80% for the D(Rho) analyte in the first testing event of 2022. 2. The laboratory obtained an unsatisfactory score of 80% for the D(Rho) analyte in the second testing event of 2022. 3. Phone interview with the laboratory manager on November 28, 2022 at 11:43 AM confirmed the laboratory failed to achieve a satisfactory performance for the D(Rho) analyte in the first and second PT events for 2022. -- 2 of 2 --