Family Health Center Of Eagle Butte

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing provider. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R 493.803 Condition: Successful participation (proficiency testing) 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 Federal proficiency testing (PT) reports 153D and 155D and the laboratory's American Proficiency Institute (API) PT report, the laboratory failed 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 -- to achieve successful participation for the hematocrit test method. Unsatisfactory results for hematocrit in two of three PT testing events (API 2025 Hematology /Coagulation first and third events) resulting in unsuccessful PT participation. 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 Federal proficiency testing (PT) reports 153D and 155D, the laboratory's American Proficiency Institute (API) PT reports and interview with the laboratory director, the laboratory failed to achieve a satisfactory score of 80% or above for the hematocrit test method for two of three testing events (API 2025 Hematology/Coagulation first and third events). Findings include: 1. Review on 12/29 /25 of the CASPER Individual Laboratory Profile PT report 155D report revealed the laboratory had received unsatisfactory scores of 0% in the API 2025 Hematology /Coagulation first event and 60% in the third event for the hematocrit test method. Review on 12/29/25 of the individual event hematocrit test method scores for the two API PT events revealed: a. 2025 Hematology/Coagulation first event hematocrit results were: (i) HSY-01 result was 29.0%. The range of acceptable results was 26.5- 28.8%. (ii) HSY-02 result was 40.2%. The range of acceptable results was 36.3- 39.4%. (iii) HSY-03 result was 16.9%. The range of acceptable results was 15.3- 16.7%. (iv) HSY-04 result was 53.7%, The range of acceptable results was 48.9- 53.0%. (v) HSY-05 result was 49.6%. The range of acceptable results was 44.9- 48.7%. b. 2025 Hematology/Coagulation third event hematocrit results were: (i) HSY- 13 result was 30.6. The range of acceptable results was 27.7-30.1%. (ii) HSY-14 result was 17.2%. The range of acceptable results was 15.6-17.0%. Interview on 1/5 /26 via email with the laboratory director revealed: a. Review of the 2025 first Hematology/Coagulation PT event results revealed a significant positive bias for the hematocrit test method. (i) Annual analyzer maintenance had been performed by the service technician. (ii) The analyzer had been recalibrated. b. Review of the 2025 third Hematology/Coagulation PT event results revealed a significant positive bias for the hematocrit test method. (i) Patient testing was ceased. Previous patient results were reviewed. No impact on patient results had been identified. (ii) The analyzer's service department had been contacted. Recommended maintenance had been performed. (iii) The analyzer was recalibrated. -- 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 the federal proficiency testing (PT) reports 153D and 155D and the laboratory's American Proficiency Institute (API) PT reports, the laboratory failed to achieve successful participation for the test method white blood cell differential. Unsatisfactory results had been received in three of three PT events (Hematology /Coagulation: 2017 3rd event and 2018 1st and 2nd events) resulting in subsequent unsuccessful PT participation. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 federal proficiency testing (PT) reports 153D and 155D and the laboratory's American Proficiency Institute (API) PT reports the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the white blood cell differential test method in three of three consecutive events (Hematology /Coagulation: 2017 3rd event and 2018 1st and 2nd events) resulting in subsequent unsuccessful performance. Findings include: 1. Review of the 9/10/18 federal Unsuccessful PT Report 153D revealed the laboratory had received unsatisfactory scores (less than 80%) for the automated differential test method in each of the three events identified above. 2. Review of the federal Individual Laboratory Profile PT Report 155D on 9/10/18 and the API Performance Summary report revealed scores for the white blood cell differential test method were less than the 80% required to pass an event per Clinical Laboratory Improvement Amendment (CLIA) requirements found at CFR 493.861(a): a. 2017 Hematology/Coagulation 3rd event score = 67% (HSY-11, 12 and 15 were graded as unacceptable). b. 2018 Hematology/Coagulation 1st event score = 73% (HSY-01, 02 and 04 were graded as unacceptable). c. 2018 Hematology/Coagulation 2nd event score = 53% (HSY-07, 08, and 10 were graded as unacceptable). 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: The laboratory director failed to provide overall management of the laboratory by failing to ensure an acceptable level of analytical performance was maintained for white blood cell differentials. (See D6023). 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 review of the federal proficiency testing (PT) reports 153D and 155D and the laboratory's American Proficiency Institute (API) PT reports the laboratory director failed to ensure an acceptable level of analytical performance was maintained for the white blood cell differential test method in three of three consecutive events -- 2 of 3 -- (Hematology/Coagulation: 2017 3rd event and 2018 1st and 2nd events) resulting in subsequent unsuccessful performance. Findings include: 1. The laboratory failed to achieve satisfactory scores in 3 of 3 consecutive PT testing events for the white blood cell differential test method. 2. The laboratory director was notified of initial unsuccessful PT performance for white cell differential test method on 5/21/18 after failing to achieve satisfactory performance in 2 consecutive PT testing events (event 3 2017 and event 1 2018). 3.

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 (PT) record review and interview with the laboratory director, the laboratory failed to achieve successful particpation for the test method white blood cell differential. Unsatisfactory results had been received in two of three PT events (2017 Hematology/Coagulation 3rd event and 2018 Hematology /Coagulation 1st event) resulting in unsuccessful PT participation. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 CASPER Reports and interview with the laboratory director, the laboratory failed to achieve satisfactory proficiency testing (PT) performance for the white blood cell differential test method in two out of three events (2017 Hematology /Coagulation 3rd event and 2018 Hematology/Coagulation 1st event) resulting in unsuccessful performance. Findings include: 1. Review of the laboratory's CASPER Reports 153D and 155D on 5/7/18 revealed the American Proficiency Institute PT scores for the white blood cell differential test method were less than the 80% required to pass an event per CLIA requirements found at CFR 493.861(a): a. 2017 Hematology/Coagulation 3rd event score = 67% (HSY-11, 12 and 15 were graded as unacceptable). b. 2018 Hematology/Coagulation 1st event score = 73% (HSY-01, 02 and 04 were graded as unacceptable). 2. Interview with the laboratory director on 5/14 /18 confirmed the failure. He stated they were aware of the issue, had ceased testing, were retraining testing personnel in specimen handling, and were working with the analyzer's manufacturer to determine the issue. -- 2 of 2 --