Decatur County Hospital

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on November 5, 2025. The laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R 493.803 Condition: Successful Participation D6000 - 42 C.F.R 493.1403 Condition: Laboratory Director, moderate complexity 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 the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute, the laboratory failed to successfully participate in two consecutive testing events for 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 -- analyte, parathyroid hormone. The laboratory had unsatisfactory scores for 2025 event 2 and 2025 event 3. Refer to D2107. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) (f) 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 Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate in two consecutive testing events for the analyte, parathyroid hormone. The findings include: 1. For 2025 event 2, the laboratory received an unsatisfactory performance score of zero for the analyte, parathyroid hormone. 2. For 2025 event 3, the laboratory received an unsatisfactory performance score of zero for the analyte, parathyroid hormone. 3. The CASPER 155 report and graded results from API confirm the findings listed above. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (2025 event 2 and 2025 event 3), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2107. -- 2 of 2 --

Summary Statement of Deficiencies 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 proficiency testing (PT) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at 8:35 am on 03/06 /2024, the laboratory failed to take and document

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1, at approximately 10:50 am on 5/10/2022; the testing personnel and laboratory director failed to attest to the routine integration of PT samples into the patient workload for six out of six proficiency testing events in 2020 and 2021. The findings include: 1. For 2020 - event 1, the laboratory director or designee did not sign the PT attestation statements for chemistry core, hematology/coagulation, immunology /immunohematology and chemistry miscellaneous. 2. For 2020 -event 2, the laboratory director or designee did not sign the PT attestation statements for chemistry core, hematology/coagulation, immunology/immunohematology and chemistry miscellaneous. Additionally, the testing personnel did not sign the PT attestation statement for chemistry miscellaneous. 3. For 2020 - event 3, the laboratory director or designee did not sign the PT attestation statements for chemistry core, hematology /coagulation, and immunology/immunohematology. 4. For 2021 - event 1, the laboratory director or designee did not sign the PT attestation statements for chemistry core, hematology/coagulation, immunology/immunohematology and chemistry miscellaneous. Additionally, the testing personnel did not sign the PT attestation statements for hematology/coagulation and chemistry miscellaneous. 5. For 2021 - event 2, the laboratory director or designee did not sign the PT attestation statements for chemistry core, hematology/coagulation, immunology/immunohematology and chemistry miscellaneous. Additionally, the testing personnel did not sign the PT attestation statements for immunology/immunohematology and chemistry miscellaneous. 6. For 2021 - event 3, the laboratory director or designee did not sign 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 -- the PT attestation statements for chemistry core, hematology/coagulation, and immunology/immunohematology. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the CA-660 coagulation records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 12:15 pm on 05/10/2022, the laboratory failed to perform calibration verification every six months for two out of three time periods for the analyte, D-Dimer from 1/1/2021 - 5 /10/22. The findings include: 1. The laboratory calibrated the analyte, D-Dimer on 9/7 /2021. 2. The D-Dimer calibration used at least 3 calibrators, and therefore met the calibration verification requirement. 3. At the time of the survey, the laboratory did not have calibration and/or calibration verification records for the time period between 1/1/2021 - 9/7/2021 and the time period between 9/7/2021 - 5/10/2022 for the analyte, D-Dimer. -- 2 of 2 --

Summary Statement of Deficiencies 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 lack of Individualized Quality Control Plan (IQCP) records, review of the Alere Triage test system quality control (QC) records for 2018, and confirmed by laboratory supervisor identifier #3 (refer to Laboratory Personnel Report) at approximately 1:50 pm on 05/23/2018, the laboratory failed to perform two levels of QC each day of patient testing on the Alere Triage test system for D-dimers. The findings include: 1. For D-dimer testing, the laboratory performed QC with each new lot of test cartridges, each new shipment and monthly. 2. Laboratory personnel identifier #6 indicated that the laboratory intended to follow manufacturer's instructions for performing QC. 3. At the time of the survey, the laboratory did not have an IQCP for the Alere Triage test system. 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 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 -- 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 review of blood bank refrigerator and freezer alarm systems procedures and records and previous survey notes from 04/21/2016 and confirmed by the laboratory supervisor, identifier #3 (refer to the Laboratory Personnel Report) at 2:15 pm on 05 /23/2018, the laboratory failed to inspect and check the blood bank refrigerator and freezer alarm systems semi-annually for four out of four time periods from 04/21 /2016 - 05/23/2018. The findings include: 1. According to the procedures, the laboratory is to perform semi-annual checks of the blood bank refrigerator and freezer alarm systems by activating the alarms and documenting the temperature at which it activates. 2. Previous survey records from 04/21/2016 documented the last alarm checks as 01/22/2016. 3. The laboratory supervisor confirmed that laboratory failed to check the blood bank refrigerator and freezer alarms during the past two years. -- 2 of 2 --