Black Hawk Health Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/06,07/2026. The laboratory was found in compliance with standard-level deficiencies cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the laboratory director, the laboratory failed to follow manufacturer's directions to ensure Siemens DCA Vantage hemoglobin A1C cartridges had not exceeded their room temperature expiration data for nine of nine cartridge type observed. Findings include: (1) On 01 /06/2026 at 11:28 am, the laboratory director stated hemoglobin A1C testing was performed on the Siemens DCA Vantage analyzer; (2) Observation of the laboratory on 01/06/2026 at 11:30 am identified nine hemoglobin A1C cartridges (Lot #0861) stored at room temperature, without documentation of when they were removed from refrigeration; (3) Review of the manufacturer's storage requirements showed the following: (a) The cartridges were stable at 2-8 degrees C (Centigrade) until the expiration date listed on the box; (b) The cartridges were stable at room temperature (18-30 degrees C) for 90 days. (4) Interview with the laboratory director on 01/06 /2026 at 11:45 am confirmed the cartridges had been placed at room temperature without a method to monitor if they exceeded the manufacturer's room temperature expiration date. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 -- (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/20/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and laboratory manager at the conclusion of the survey. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director and laboratory manager, the laboratory failed to utilize the demonstrated reportable ranges for two of five analytes reviewed on the Ortho Vitros XT 3400 analyzer put into use in December 2021. Findings include: (1) On 03/20/2024 at 10:45 am, the laboratory manager stated the laboratory began using the Ortho Vitros XT 3400 analyzer to perform routine chemistry testing, which included the analytes Cholesterol and CK (Creatine Kinase), in December 2021; (2) A review of the performance specification records identified the laboratory had demonstrated the following reportable ranges: (a) Cholesterol - 47.2-417.2 mg/dL (b) CK - 48.7-1671.4 U/L (3) Interview with the laboratory manager and laboratory director on 03/20/2024 at 02:00 pm, confirmed the laboratory was using the following reportable ranges instead of those that had been demonstrated by the laboratory: (a) Cholesterol - 0-90000000 mg/dL (b) CK - 0-1600 U/L 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 -- D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for five of 13 proficiency testing events reviewed in 2022 and 2023. Findings include: (1) A review of 2022 and 2023 proficiency testing events identified attestation statements had been signed up to three months after the samples had been tested for five of 13 events reviewed: (a) First Hematology Event 2022 - The sample testing had been completed on 03/30/2022 and the attestation statement had not been signed by the previous laboratory director until 06/24/2022; (b) First Chemistry Core Event 2022 - The sample testing had been completed on 02/01/2022 and the attestation statement had not been signed by the previous laboratory director until 03/18/2022; (c) Second Hematology Event 2022 - The sample testing had been completed on 08/03/2022 and the attestation statement had not been signed by the previous laboratory director until 09/16/2022; (d) First Chemistry Core Event 2023 - The sample testing had been completed on 01/27/2023 and the attestation statement had not been signed by the previous laboratory director until 04/07/2023; (e) Second Chemistry Core Event 2023 - The sample testing had been completed on 06/02/2023 and the attestation statement had not been signed until the current laboratory director (hired in August 2023) signed it on 08/30/2023. (2) The records were reviewed with the laboratory director who stated on 03/20/2024 at 02:00 pm the attestation statements had not been signed timely as stated above. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director and laboratory manager, the technical consultant failed to ensure personnel performing moderate complexity testing had been evaluated at least annually for two of two persons during the review period of December 2021 through the current date. Findings include: (1) A review of personnel records for two persons performing moderate complexity testing from December 2021 through the current date identified no evidence annual competency evaluations had been performed for two of two persons as follows: (a) Laboratory Manager - Not performed until 10/30/2023 (b) Testing Person #2 - Not -- 2 of 3 -- performed until 10/30/2023 (2) The records were reviewed with the laboratory director and laboratory manager. Both stated on 03/20/2024 at 10:50 am, the annual evaluations had not been performed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/01/2021. The findings were reviewed with the laboratory manager at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to following the manufacturer's instructions for specimen transport and storage for 1 of 3 patient specimens. Findings include: (1) On 12/01/2021 at 09:45 am, the laboratory manager stated the following to the surveyor: (a) The laboratory performed COVID-19 testing using the following instrument (i) Abbott BinaxNOW COVID-19 Ag Card - qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swabs. (2) The surveyor reviewed the manufacturer's product insert titled, "BinaxNOW COVID-19 Ag" which stated, "For best performance, direct nasal swabs should be tested as soon as possible after collection. If immediate testing is not possible, and to maintain best performance and avoid possible contamination, it is highly recommended the nasal swab is placed in a clean, unused plastic tube labeled with patient information, preserving sample integrity, and capped tightly at room temperature (15-30C) for up to one (1) hour prior to testing. Ensure the swab fits securely within the tube and the cap is tightly closed. If greater than one (1) hour delay occurs, dispose of sample. A new sample must be collected for testing."; (3) The surveyor reviewed 3 test reports for patients tested on 04/14/2021, 08/26/2021, and 12/01/2021 and identified the following: (a) Patient Report #1 - Specimen collection date and time (04/14/2021 at 09:55 am) and 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 3 -- result date and time (04/14/2021 at 09:55 am); (4) The surveyor was not able to determine if the results had been interpreted within the one (1) hour after collection since the time between the specimen collection date and time and the result date and time were identical; (5) The surveyor reviewed the records with the laboratory manager. The laboratory manager stated on 12/01/2021 at 12:05 pm the laboratory could not prove the results had been interpreted within one (1) hour after collection as indicated above. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to review and evaluate proficiency testing results for 2 of 20 events. Findings include: (1) On 12/01/2021, the surveyor reviewed 2020 and 2021 proficiency testing records. The following biases were identified (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) First 2021 Chemistry Core Event (i) Cholesterol HDL (High Density Lipoprotein) - 3 of 5 results exhibited a positive bias (aa) Sample CH-06 - SDI of 2.7 (bb) Sample CH-07 - SDI of 3.6 (cc) Sample CH-08 - SDI of 2.0 (b) Third 2021 Chemistry Core Event (i) Total Cholesterol - 3 of 5 results exhibited a positive bias (aa) Sample CH-11 - SDI of 2.0 (bb) Sample CH-12 - SDI of 2.4 (cc) Sample CH- 15 - SDI of 2.7 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The records were reviewed with the laboratory manager. The laboratory manager stated on 12/01/2021 at 11:30 am the biases had not been addressed. 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 records and interview with the laboratory manager, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program for 2 of 3 Chemistry Miscellaneous events reviewed. Findings include: (1) On 12/01/2021, the surveyor reviewed proficiency testing records for the first and second events in 2020 and the first event of 2021. The following was identified for 2 of 3 Chemistry Miscellaneous events: (a) First 2020 Chemistry Miscellaneous Event for Microalbumin - 1 of 3 results had not been graded by the proficiency testing program: (i) For 1 of 3 results (MA-01), the following was identified: (aa) MA-01 - Under "Expected Results" it stated, "See Data Summary". There was no evidence the laboratory reviewed the commentary contained in the "Participant Summary Report" to evaluate their result. (b) Second 2020 Chemistry -- 2 of 3 -- Miscellaneous Event for Microalbumin - 1 of 3 results had not been graded by the proficiency testing program: (i) For 1 of 3 results (MA-05), the following was identified: (aa) MA-05 - Under "Expected Results" it stated, "See Data Summary". There was no evidence the laboratory reviewed the commentary contained in the "Participant Summary Report" to evaluate their result. (2) The surveyor reviewed the records with the laboratory manager who stated on 12/01/2021 at 11:25 am, the laboratory had not evaluated the results that were not graded by the proficiency testing program and

Summary Statement of Deficiencies D0000 The recertification survey was performed 10/10/19. The laboratory was found out of compliance with the following CLIA regulations: 493.1215: D5024: Condition: Hematology 493.1403: D6000: Condition: Laboratory Director, Moderate Complexity 493.1409: D6033: Condition: Technical Consultant, Moderate Complexity The findings were reviewed with laboratory supervisor at the conclusion of the survey. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of records, manufacturer's instructions, written policies and procedures, observation, and interview with the laboratory supervisor, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493.1281 through 493.1299 for the specialty of Hematology. Findings include: (1) The laboratory failed to thoroughly address Hematology proficiency testing responses that obtained biases and failed to take

Summary Statement of Deficiencies D0000 The findings were reviewed with the laboratory manager at the conclusion of the survey. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: FAILURES (1) At the beginning of the survey, surveyor #2 reviewed 2016 and 2017 proficiency testing records. The following was identified: (a) 2016 Chemistry Group 2 - 1st event (i) ALT (Alanine Aminotransferase) The laboratory received a score of 80% (failed 1 of 5 results). There was no evidence that