Hawarden Regional Healthcare

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on May 12, 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 (API), the laboratory failed to successfully participate in two consecutive testing 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 -- events for the analyte, hematocrit. The laboratory had unsatisfactory scores for 2024 event 3 and 2025 event 1. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) 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 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 achieve satisfactory performance (80% or greater) for two consecutive testing events for the analyte, hematocrit. The findings include: 1. For the analyte, hematocrit, the laboratory received unsatisfactory performance scores of 60% for 2024 testing event 3 and 50% for 2025 testing event 1. 2. 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 API (2024 event 3 and 2025 event 1), 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 D2130. -- 2 of 2 --

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 review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10: 30 am on 10/14/2020, the laboratory failed to perform a self evaluation of ungraded PT scores for one out of five testing events (2019 event 2) in 2019 and 2020. The findings include: 1. For 2019 testing event 2, the laboratory received ungraded PT test scores for the following: *2019 Hematology/Coagulation survey- Lymphocyte percentage, specimen ABT-08 2. At the time of the survey, the laboratory did not have additional documentation or

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of hematology quality control (QC) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 7/26/2018, the laboratory failed to retain the daily quality control records for 28 out of 28 days in February 2018 for the analytes: percent and absolute neutrophil count, percent and absolute lymphocyte count, percent and absolute monocyte count, percent and absolute eosinophil count, percent and absolute basophil count, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, and mean platelet volume (MPV). The findings include: 1. The laboratory performed two levels of QC (rotating between low, normal, and high) each day of patient testing. 2. At the end of each lot number of QC the laboratory printed a levy-jennings chart documenting the QC results. 3. The levy- jennings chart for lot numbers L7359 (low), N7359 (normal), and H7359 (high) of QC from February 2018 did not contain QC results for the analytes: percent and absolute neutrophil count, percent and absolute lymphocyte count, percent and absolute monocyte count, percent and absolute eosinophil count, percent and absolute basophil count, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, and mean platelet volume (MPV). 4. The laboratory could not retrieve additional QC records for the listed analytes, as the hematology analyzer did not retain more than four months worth of QC records. 5. At the time of the survey, the laboratory did not have any additional QC records for the listed analytes. 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 -- 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 calibration verification records and confirmed by laboratory personnel identifier #1 (refer to Laboratory Personnel Report) at approximately 9:15 am on 07/26/2018, the laboratory failed to perform calibration verification using a low, mid-point and high value every six months for two out of two time periods from June 2017 - June 2018 for the analytes: sodium, potassium, chloride, and vitamin D. The findings include: 1. On 10/11/2017 the laboratory performed calibration verification for the analytes: sodium, potassium and chloride using a low and high value. The calibration verification did not include a mid-point value. 2. On 10/11 /2017 the laboratory performed calibration verification for the analyte, vitamin D, using a mid-point and high value. The calibration verification did not include a low value. 3. On 3/14/2018 the laboratory performed calibration verification for the analytes: sodium, potassium and chloride using a mid-point value. The calibration verification did not include a low or high value. 4. On 4/18/2018 the laboratory performed calibration verification for the analyte, vitamin D, using a mid-point value. The calibration verification did not include a low or high value. 5. At the time of the survey, the laboratory did not have any additional calibration verification records. -- 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 review of proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the specialty, hematology and the analyte, white blood cell, for two out of three consecutive testing events: 2017 events 1 and 3 (refer to D2130 and D2131). D2130 HEMATOLOGY CFR(s): 493.851(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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) reports and records, the laboratory fails to achieve satisfactory performance for the analyte, white blood cell count, for two out of three consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 20% for 2017 testing event 1 and 40% for 2017 testing event 3. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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 proficiency testing reports and records, the laboratory fails to achieve an overall testing event score of satisfactory performance for two out of three consecutive testing events for the specialty, hematology. The laboratory received unsatisfactory performance scores of 76% for 2015 testing event 1 and 75% for 2017 testing event 3 for the specialty, hematology. -- 2 of 2 --