Glenns Ferry Health Center Inc

Summary Statement of Deficiencies D2046 MYCOLOGY CFR(s): 493.827(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 review of Proficiency Testing (PT) results for 2020 from the American Proficiency Institute (API) and an interview with the laboratory lead on 1/28/2022, the laboratory failed to achieve an overall testing event score of satisfactory performance for three (3) consecutive testing events for the subspecialty of mycology for the analyte potassium hydroxide (KOH) preparation. The findings include: 1. A review of graded PT results from API identified that the laboratory failed to achieve satisfactory results for the subspecialty of mycology for the following analyte: Analyte Year Event Score KOH 2020 1 50% KOH 2020 2 50% KOH 2020 3 0% 2. An interview with the laboratory lead on 1/28/2022 at 10:45 am confirmed the above PT failures. 3. The laboratory reports performing 100 KOH preparations annually. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies 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 record review of proficiency testing (PT) from the American Proficiency Institute (API) and an interview with the laboratory lead on 1/28/2022, the laboratory failed to review and evaluate PT results that were less than 100% but were equal to or greater than 80%. The findings include: 1. A review of PT records from API for 2020 event two identified that the laboratory failed to evaluate results for the analyte white blood count (WBC), which had a score of 80%. 2. An interview with the laboratory lead on 1/28/2022 at 10:42 am confirmed that the laboratory failed to evaluate the PT WBC results for 2020 event two. 3. The laboratory reports performing 245 hematology tests annually. 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 D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on an interview with the laboratory manager and proficiency testing (PT) record review, the laboratory director failed to sign the attestation statements from the the American Association of Bioanalysts (AAB) for complete blood count (CBCs) and wet mounts in 2017. Findings: 1. An AAB PT document review revealed the laboratory director and testing personnel failed to sign the attestation statements for CBC and wet mount analytes for 2017. 2. An interview on March 22, 2018 at 9:40 AM, with the operation manager, confirmed the laboratory director and testing personnel failed to sign the PT attestation statements for 2017. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- This STANDARD is not met as evidenced by: Based on a record review and an interview with the operation director, the laboratory failed to retain quality control results and patient test results printed from the QCB Star complete blood count (CBC) analyzer since the last survey on March 23, 2016 at both the Glenns Ferry Health Center and the Desert Sage Health Center in Mountain Home. Findings: 1. A record review of the QBC Star CBC print-outs for quality control and patient test results revealed the laboratory failed to retain quality control results and patient CBC results since the last survey at both the Glenns Ferry Health Center and the Desert Sage Health center in Mountain Home. 2. An interview on March 22, 2018 at 10:30 AM, with the operation manager, confirmed the testing personnel from both Health Centers failed to retain quality control results and patient test results printed from the QBC Star analyzer. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and an interview with the operation manager, the laboratory failed to evaluate their performance on the American Association of Bioanalysts (AAB) PT for complete blood counts (CBC), performed at Glenns Ferry Health centers and the Desert Sage Health Center in Mountain Home and Valley Health Center in Grand View, that was not graded during since 2016. Findings: 1. A record review of CBC PT results from AAB, revealed the leukocytes from the 2017 quarter 3 was not graded. 2. A record review of CBC PT results from AAB, revealed the leukocytes, hematocrit, and platelets from the 2017 quarter 2 was not graded. 3. A record review of CBC PT results from AAB, revealed the leukocytes was not graded and hematocrit the incorrect from the 2017 quarter 1. 4. A record review of CBC PT results from AAB, revealed the platelets from the 2016 quarter 3 was not graded. 5. An interview on March 22, 2018 at 9:30 AM, with the operation manager, confirmed the laboratory failed to evaluate their performance on ungraded analytes since the last survey. 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 a record review and an interview with the operation director, the laboratory failed to verify the accuracy of potassium hydroxide (KOH) at least twice annually in 2017. This is a repeat deficiency from the March 23, 2016 survey. Findings: 1. A record review of American Association of Bioanalysts proficiency test (PT) results, -- 2 of 14 -- revealed the laboratory failed KOH testing for 2017 Quarter 3. 2. An interview on March 22, 2018 at 9:30 AM, with the operation manager, confirmed the laboratory failed to verify the accuracy of KOH proficiency testing at least semiannually in 2017. 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 testing (PT) record review and an interview with the operation manager, the laboratory failed to document the evaluation of unsatisfactory PT results for potassium hydroxide (KOH) for the American Association of Bioanalysts (AAB) 2017 quarter 3 events. Findings: 1. A review of PT results from AAB 2017 quarter 3, revealed the laboratory failed to document the evaluation and