Mitchell Medical Center

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to follow its specimen stability policy for its Complete Blood Count (CBC) testing for 3 (Patients 211155, 206332, and 202607) of 10 patient test reports reviewed. Findings include: 1. A review of the laboratory's Beckman Coulter DxH hematology analyzer manufacturer's instructions revealed a section titled "Specimen Stability and Storage- Whole Blood" stating, "Sample stability may be evaluated as the change (drift) of the parameter during 24 hours at 18 to 26 degrees C (64 to 79 degrees F). For a refrigerated temperature of 2 to 8 degrees C (35.6 to 46.4 degrees F), drift may be evaluated at 8 hours for WBC and differential parameters, and at 24 hours for the remainder of the parameters. The drift should be within the difference or percent difference, whichever is greater. Samples stored at refrigerated temperatures are removed from storage, mixed by inversion 20 times, allowed to remain at ambient room temperature for 30 minutes, and remixed by inversion 20 times prior to analysis." 2. A review of patient test reports revealed the following patients had Complete Blood Count (CBC) testing more than 24 hours after the specimen was collected: a. Patient 211155 had a specimen collected on 11/15/22 at 10:02 am and testing was performed and reported on 11/16/22 at 1:35 pm. b. Patient 206332 had a specimen collected on 4/26/22 at 8:28 am and testing was performed and reported on 4 /27/22 at 5:13 pm. c. Patient 202607 had a specimen collected on 12/7/21 at 8:50 am 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 -- and testing was performed and reported on 12/8/21 at 11:01 am. 3. An interview on 12 /7/22 at 1:08 pm with the Technical Consultant confirmed the patients listed above had CBC testing performed on specimens that had exceeded their stability. -- 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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the chemistry analyte uric acid. Findings include: The laboratory failed to attain a score of at least 80% of acceptable responses for the chemistry analyte uric acid, which is unsatisfactory performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 or test in two consecutive 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 the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte uric acid in 2 (2nd event of 2022 and 3rd event of 2020) of 2 consecutive testing events. Findings include: 1. A review of the CMS database and the API proficiency testing reports revealed the laboratory had unsatisfactory performance for 2 of 2 consecutive proficiency testing events constituting unsuccessful performance for the chemistry analyte uric acid: PT Event Score 2nd event 2020 60% 3rd event 2020 60% -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to rotate proficiency testing samples among all testing personnel routinely performing patient testing for 6 (1 event in 2021, 3 events in 2020, and 2 events in 2019) of 6 testing events reviewed. Findings include: 1. Review of the laboratory's CMS-209 form revealed it had 4 testing personnel for moderate complexity testing. 2. A review of the laboratory's American Proficiency Institute (API) proficiency testing attestations revealed Testing Personnel #1 performed testing for all specimens in the following proficiency testing events: a. 2021 Hematology /Coagulation 1st Event b. 2020 Hematology/Coagulation 3rd Event c. 2020 Hematology/Coagulation 2nd Event d. 2020 Hematology/Coagulation 1st Event e. 2019 Hematology/Coagulation 3rd Event f. 2019 Hematology/Coagulation 2nd Event 3. A review of the laboratory's "Proficiency Testing" procedure revealed a section stating, "If more than one person is running the lab tests they will alternate the running of the samples each time they arrive. It there are more than 3 techs each tech will be in the rotation so that a different tech runs one sample. If there are more than five tech, the rotation will continue with the next testing event." 4. An interview on 6 /14/21 at 4:15 pm with TC1 confirmed the laboratory did not rotate its proficiency testing specimens among its routine testing staff. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 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 -- 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: . The laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to perform and document calibration procedures when calibration verification failed to meet the laboratory's acceptable limits. Refer to D5437. 2. The laboratory failed to perform calibration verification at least every 6 months. Refer to D5439. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to perform and document calibration procedures when calibration verification failed to meet the laboratory's acceptable limits for 1 (Thyroxine) of 25 analytes requiring calibration verification procedures. Findings include: 1. A review of the laboratory's "Linearity/Calibration Verification" reports revealed Thyroxine, performed on 6/7/21, had the following results: a. Slope of 0.833 b. Y-intercept of 2.058 c. R-Squared of 0.561 2. A review of the laboratory's "Linearity/Calibration Verification" reports revealed Thyroxine had a note stating "rerun FT4". 3. A review of the laboratory's "Calibration Verification" procedure revealed a lack of acceptance criteria used to determine when calibration verification procedures are acceptable. 4. A review of the laboratory's test records revealed a total of 10 patients had testing performed after the calibration verification procedures for Thyroxine were performed. 5. An interview on 6/14/21 at 4:15 pm with TC1 confirmed the calibration verification for Thyroxine was not acceptable and additional calibration verification procedures or

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 procedure review, record review, and interview with technical consultant #1 (TC1), the laboratory failed to manually check the instrument calculated parameters for the very low density lipoprotein (VLDL), low density lipoprotein (LDL) and the glomerular filtration rate (GFR) annually for 2 (2017 and 2018) of 3 years reviewed. Findings include: 1. Procedure review for "LIS Policy" states "At least one time per year the LIS will be checked to validate VLDL, LDL, and GFR calculations. Five patients will be checked to make sure the results are being calculated correctly." 2. Record review revealed a lack of documentation for the annual calculation checks for 2017 and 2018. 3. An interview with TC1 on May 22, 2019 at 9:40 am confirmed the annual calculation checks were not performed and documented in 2017 and 2018. . 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 --