Satanta District Hospital & Ltcu Nur

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on the review of the Quality Assurance (QA) plan, lack of post analytical review documentation and interview, the laboratory failed to perform post analytical quality assessment to ensure the accurate transfer of patient test information. Findings: 1. Review of the "Quality Assurance Plan" revealed no process for the review of manually entered patient test results into the electronic health record. 2. A request for documentation of the review of manually entered patient test results for April 3, 2019 to May 18, 2021 was not available at the time of survey. Technical Consultant (TC) #2 stated they did not review the patient record for manually entered results. 3. Interview with TC #2 on May 18, 2021 at 11:05 a.m. confirmed, the laboratory failed to perform post analytical quality assessment to ensure the accurate transfer of patient test information. 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 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: Review of the Sysmex XS1000i calibration records for 2017 and 2018 and interview with testing personnel #1 (laboratory personnel report CMS-209), the laboratory failed to retain the calibration assay sheets for the required two year period. Findings were: 1. Sysmex XS1000i calibration records for February 20, 2017. 2. Sysmex XS1000i calibration records for February 7, 2018. 3. Assay sheets were not available was verified during interview with testing personnel #1 at 1:30 PM on June 20th, 2018. 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 review of American Association of Bioanalysts (AAB) proficiency tests (PT) and interview with testing personnel #1 (refer to laboratory personnel report CMS-209) at 09:00 am on June 20, 2018, the laboratory failed to have two passing scores during 2017 to verify the accuracy of the urine sediment test. Findings were:. 1. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Review of AAB PT Urinalysis for 2017: 1st Quarter Urine Sediment had a score of 50% 3rd Quarter Urine Sediment had a score of 50% 2. Testing personnel confirmed that the laboratory didn't perform any other accuracy for urine sediment. 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 review of American Association of Bioanalysts (AAB) proficiency testing (PT) records for 2017 and confirmed by laboratory testing personnel #1 (refer to the Laboratory Personnel Report CMS-209) at 08:30 am on June 20, 2018, the laboratory failed to ensure that evaluation of an unacceptable proficiency testing event was documented. The Findings include: 1. AAB 2017 1st Event Urinalysis, Urine Sediment - Image 1 & Image 2 - score 50% Coagulation, specimen 2 - score 36.2 - grading range (41.4 to 56.0) 2. AAB 2017 2nd Event Basic Chemistry, Bicarbonate (Total CO2), specimen 4 - score 26 - grading range (27 to 40) Hematology, Cell Identification, specimen 2 3. AAB 2017 3rd Event Urinalysis, Urine Sediment - Image 1 - score 50% 4. No