Grand Island Clinic Inc

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on November 10, 2025. 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 condition deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director 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 a proficiency testing desk review from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and College of American Pathologists 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 -- (CAP) 2025 records, the laboratory did not successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Bacteriology. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) (e) 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 a proficiency testing desk review of CASPER 0155 report and College of American Pathologists (CAP) 2025 proficiency testing records and phone interview with the laboratory manager, the laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive testing events or two out of three consecutive testing events in the subspecialty of Bacteriology. Findings are: 1. Review of the CASPER 0155 report revealed the following results: Bacteriology 2025 - 1st Event the laboratory received an unsatisfactory score of 78% for Bacteriology. Bacteriology 2025 - 2nd Event the laboratory received an unsatisfactory score of 66% for Bacteriology. 2. Review of the CAP 2025 proficiency testing records confirmed the laboratory received the above results. 3. Phone interview with the laboratory manager on November 10, 2025 at 12:09 PM, confirmed the above results. 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 a proficiency testing desk review of CASPER 0155 report and College of American Pathologists 2025 (1st and 2nd events) records, the laboratory director failed to manage successful proficiency testing participation. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 a proficiency testing desk review of CASPER 0155 report and College of American Pathologists 2025 (1st and 2nd events) records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2028. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records, lack of any verification records, and an interview with the laboratory supervisor, the laboratory failed to have a system for verifying the accuracy of the testing for troponin and prostate specific antigen (PSA) for 2023, one out two years reviewed. Findings are: 1. The laboratory's proficiency test results from 2022 and 2023 did not include testing for troponin and PSA in 2023. 2. Interview on 4/23/2024 at 10:59 AM, the laboratory supervisor confirmed the laboratory had not enrolled in PT for troponin and PSA nor had the laboratory performed accuracy verification for these analytes in 2023. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on surveyor review of competency assessments, lack of documentation, and interview with the technical supervisor the laboratory failed to perform competency assessment in 2023 for six out of six testing personnel. 1. Review of the laboratory's 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 -- competency assessment revealed no competency assessment performed in 2023. 2. Interview with the technical supervisor on 4/23/2024 at 11:31 AM confirmed the laboratory did not perform competency assessments in 2023 for six out of six testing personnel. -- 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 proficiency testing desk review, the laboratory repeatedly failed to successfully participate in proficiency testing for the subspecialty of Bacteriology. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of data from proficiency testing (PT) reports and the laboratory's PT results from the PT organization, American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE), the laboratory failed to achieve satisfactory performance in the subspecialty of Bacteriology and has sustained a subsequent occurrence of unsuccessful participation in PT. Findings are: 1. AAB-MLE, 2023 Event 1, Bacteriology score 75% 2. AAB-MLE, 2023 Event 2, Bacteriology score 50% 3. AAB-MLE, 2023 Event 3, Bacteriology score 75% -- 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 off-site proficiency desk review and phone interview with the laboratory, the laboratory failed to successfully participate in proficiency testing for the subspecialty of Bacteriology. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on off-site proficiency desk review and phone interview with the laboratory on 8/4/2023 at 12:54 PM, the laboratory failed to achieve satisfactory performance in the subspecialty of Bacteriology. Findings are: 1. 2023 first event subspecialty - bacteriology, score 75% 2. 2023 second event subspecialty - bacteriology, score 50% 3. Phone interview with the laboratory confirmed the unsuccessful scores. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the laboratory's list of tests performed and interview with technical consultant, in 2019 the laboratory failed to enroll in an approved proficiency testing program for Human Chorionic Gonadoptropin, qualitative serum and Rheumatoid Factor, qualitative serum. Findings are: 1. Review of the laboratory's list of tests performed revealed the laboratory performed two hundred and seventy five moderate complexity Human Chorionic Gonadoptropin, qualitative serum and seventy five moderate complexity Rheumatoid Factor, qualitative serum in 2019. 2. Interview with technical consultant on 9/9/2020 at 3:00 PM confirmed the laboratory had not enrolled in 2019 proficiency testing for moderate complexity Human Chorionic Gonadoptropin, qualitative serum and for moderate complexity Rheumatoid Factor, qualitative serum. 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 --

Summary Statement of Deficiencies D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of centrifuge tachometer checks, manufacturer's instructions, validation procedures and interview with the general supervisor at 11:50 AM on 4/18 /2018 the laboratory failed to validate performance characteristics for the urine centrifuge used for the preparation of urine sediment. Findings are: 1. Review of the tachometer checks for the centrifuge used for the preparation of urine sediment revealed a tachometer reading of 9808 revolutions per minute (RPM) on 2/1/2018. With the 4 centimeter radius of this centrifuge this results in a relative centrifugal force (RCF) of 4302. 2. Review of the manufacturer's instructions indicated this high speed centrifugation for 45 seconds with no textbook references or references by the manufacturer that urinary casts could be detected by this method. 3. Review of the 12 patient samples used by the laboratory to validate this method did not include urinary casts in any of the 12 samples tested. 4. Interview with the general supervisor confirmed the laboratory did not include samples with possible casts and had not observed any casts present in samples since this centrifuge with increased speed had been put in use in July of 2017. 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 --