Lindsborg Community Hospital

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of proficiency test (PT) performance evaluation records from American Proficiency Institute (API) and interview on 11/11/2021 at 2:15 p.m. with general supervisor #1 (GS#1), the laboratory failed to self-evaluate 18 not graded results from four events dated 5/22/2019 to 11/11/21. Findings: 1. 2020 Hematology /Coagulation 1st Event not graded results: a. Fecal WBC FW-01. b. No evidence of self-evaluation was available at the time of survey. 2. 2020 Hematology/Coagulation 2nd Event not graded results: a. Blood Cell ID (Educational) ECI-06, ECI-07, ECI-08, ECI-09, ECI-10. b. No evidence of self-evaluation was available at the time of survey. 3. 2020 Hematology/Coagulation 3rd Event not graded results: a. Blood Cell ID (Educational) ECI-11, ECI-12, ECI-13, ECI-14, ECI-15. b. Urine Sediment US-06. c. No evidence of self-evaluation was available at the time of survey. 4. 2020 Immunology/Immunohematology 3rd Event not graded results: a. Antibody Screen SER-11. b. No evidence of self-evaluation was available at the time of survey. 5. 2021 Hematology/Coagulation 2nd Event not graded results: a. Blood Cell Identification BCI-07. b. Platelet Estimate (DIF) DIF-02. c. Blood Cell ID (Educational) ECI-06, ECI-07, BCI-09. d. No evidence of self-evaluation was available at the time of survey. 6. Interview with GS#1 11/11/21 at 2:15 p.m. confirmed, the laboratory failed to self- evaluate 18 not graded proficiency testing results from four events dated 5/22/2019 to 11/11/21. 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 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 review of proficiency testing records the laboratory failed to successfully participate in proficiency testing from American Proficiency Institute for the ABO group and Rh typing (overall testing event) for two out of three consecutive proficiency testing events: 2019 event 2 and event 3 (refer D2163). D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory for 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 review of 2019 proficiency testing (PT) records and test menu, the laboratory failed to achieve satisfactory PT performance for the overall testing event score for two out of three PT events for the analytes ABO group and Rh typing. The laboratory received unsatisfactory performance scores of 90% as the overall testing event score for the analytes, ABO and Rh typing, for 2019 event 2 and event 3. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Lindsborg Community Hospital's Laboratory was found to be in substantial compliance with 42 CFR Part 493, Requirements for Laboratories as a result of an onsite inspection on 21 May 2019. 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 D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the laboratory's wet preparation patient test logs, final test reports, and interview with Technical Consultant (TC) #3, the laboratory failed to have an adequate manual or electronic system(s) in place that ensured test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination. Findings Include: 1. Review of the laboratory's wet preparation patient test log titled "KOH / Wet Mount" found a patient tested on 06/27/2018 had the following results documented: Yeast / Fungi NS Trichomonas NS Clue Cells NS WBC 5 - 10 Other RBCs Bacteria 2. Review of the patient's electronic final test report found the following results reported: WBC/OIF 10 - 20 Trichomonas /HPF No motile trichomonas vaginalis seen Clue Cells /HPF No clue cells seen Yeast Result No yeast of fungal elements seen No documentation of red blood cells (RBCs) or bacteria was present. 3. TC #3 confirmed the patient's results documented on the test log did not match the test results reported on the final test report. The interview occurred 08/28/2018 at 5:28 PM. 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 --