Dodge County Hospital Laboratory

Summary Statement of Deficiencies D0000 A recertification survey was performed on February 20 and 21, 2024. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. 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 the Quality Control (QC) documents for the GEM Premier 3000 Blood Gas analyzer (GEM3000), and staff interview, the Blood Gas Lab (BGL) failed to retain the package inserts from the QC lot numbers for 2022 and 2023. Findings: 1. A review of the monthly QC documents for the GEM3000, for 2022 and 2023 revealed the laboratory failed to retain copies of the package inserts that contained the manufacturers QC ranges, for each lot number. 2. Interview with the Respiratory Department Manager and the Laboratory Manager, on 2/21/2024, in the Laboratory Manager's office, at approximately 1 pm, confirmed the aforementioned statement. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. 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 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 19 - April 20, 2022 . The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The laboratory was determined to be in Immediate Jeopardy due to the laboratory's inability to demonstrate compliance in the speciality of Chemistry, subspecialty of Blood Gas (Ph, PO2, PCO2). The following deficiencies were cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on document review and staff interviews, the laboratory failed to enroll in Proficiency Testing (PT) for the subspecialty of Blood Gas ( analytes of PH #315, PO2 #325, and PCO2 #335), resulting in Immediate Jeopardy. Findings include: 1. Review of the CMS CASPER Report 096D revealed the laboratory did not participate in American Proficiency Institute (API) PT for the following events: 2021 #1, 2021 #2, 2021 #3, and 2022 #1 in the subspecialty of Blood Gas (analytes of PH #315, PO2 #325, and PCO2 #335). 2. Review of documention provided to the survey team revealed the Blood Gas, General Supervisor, did not order PT for PH #315, PO2 #325, or PCO2 #335 in 2021 thru testing event #1 of 2022. 3. Interviews with staff #2 and staff #13 (CMS 209) via telephone, on 4/19/22, at approximately 2:45 PM, in 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 10 -- Technical Supervisor and General Supervisor's office, confirmed the the PT samples were not ordered or analyzed from 2021 - 2022 event #1. 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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for Compatibility Testing #895 in 2020 event #3 and in 2021 event #2 resulting in the unsuccessful performance for Compatibility Testing #895. Findings include: Refer to D2173 D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review, using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153, and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in Compatibility Testing #895, in 2020 event #3 and 2021 event #2 , resulting in the first unsuccessful performance. Findings include: 1. Desk review of Casper Reports 153 and 155 revealed the laboratory failed analyte #895 Compatibility Testing on event #3 of 2020 with a score of 80% and event#2 of 2021 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports, from American Proficiency Institute (API), confirmed the laboratory failed Compatibility Testing #895, on 2020 Event #3 and 2021 Event #2, resulting in the first unsuccessful performance. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 -- 2 of 10 -- Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the Quality Assurance (QA) Policy and staff interview, the laboratory failed to provide documentation of QA monitoring and evaluation of the overall quality of the general laboratory systems. There were no documents for the years 2020, 2021, or 2022. Reference: D5293 D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 7, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for Compatibility Testing #895 in 2020 event three (first unsuccessful) and in 2021 event two resulting in the second unsuccessful occurrence for Compatibility Testing #895. Findings include: Refer to D 2173 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 -- D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in Compatibility Testing #895 2020 event #3 , resulting in the first unsuccessful occurrence. The laboratory failed to maintain satisfactory performance in Compatibility Testing #895 2021 event #2 , resulting in the second unsuccessful occurrence. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #895 Compatibility Testing on : - event 3 of 2020 with a score of 80% - event 2 of 2021 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed Compatibility Testing #895 on 2020 Event 3 and 2021 event 2 resulting in the first and second unsuccessful performances. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: The laboratory director failed to maintain compliance with successful proficiency testing (PT) for Compatibility Testing #895 in 2020 event #3 resulting in the 1st unsuccessful PT occurrence and 2021 event #2 resulting in the second unsuccessful PT occurrence. Findings include: Refer to D6079 D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and review of the laboratory's 2020, and 2021 proficiency testing (PT) -- 2 of 3 -- evaluation reports from the American Proficiency Institute (API) , the laboratory director failed to ensure the laboratory maintained satisfactory performance in Compatibility Testing #895 resulting in the first and second unsuccessful PT occurrence for Compatibility Testing #895. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory Compatibility Testing #895 scores: - 2020 event #3 80% - 2021 event #2 60% 2. Review of the API 2020 event three evaluation report confirmed an unacceptable score in Compatibility Testing #895 of 80%. 3. Review of the API 2021 event two evaluation report confirmed an unacceptable score for Compatibility Testing #895 of 60% . -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on November 12, 2020. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (Event 1 and 2 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 -- of 2020), resulting in the first unsuccessful occurrence for Activated Partial Thromboplastin Time (PTT) #0835. The findings include: Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (Event 1 and 2 of 2020), resulting in the first unsuccessful occurrence for Activated Partial Thromboplastin Time (PTT) #0835. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte PTT #0835 on Event 1 of 2020 with a score of 20% and Event 3 of 2020 with a score of 60% 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 3. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed two consecutive events (Events 1 and 2 of 2020) for PTT, resulting in the first unsuccessful performance. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on an in-office desk review of proficiency testing (PT) records, the Laboratory Director failed to ensure the laboratory successfully participated in two consecutive proficiency testing events (Events 1 and 2 for 2020) for analyte # 0835, Activated Partial Thromboplastin Time (PTT) in the specialty of Hematology Findings include: Refer to: (D2016 and D2130) D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (Event 1 and 2 of 2020), resulting in the first unsuccessful occurrence for Activated Partial Thromboplastin Time (PTT) #0835. Findings include: 1. Desk review of Casper -- 2 of 3 -- Reports 153 and 155 disclosed the laboratory failed analyte PTT #0835 on Event 1 of 2020 with a score of 20% and Event 3 of 2020 with 60% 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 3. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed two consecutive events (Events 1 and 2 of 2020) for PTT, resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on November 5, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency test (PT) document review and staff interview, the laboratory failed to perform required

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --