Summary:
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: . Based on record review, lack of documentation, and interview with Testing Personnel (TP) #1, the laboratory failed to retain the Beckman Coulter DxH520 hematology analyzer quality control, patient printouts, and background counts for 2 (2021 and 2022) of 2 years reviewed. Findings include: 1. A record review revealed for 2 (2021 and 2022) of 2 years the Beckman Coulter analyzer quality control records were not retained as follows: Quality Control records a. 1/04/2021 b. 4/01/2021 Background counts a. 1/04/2021 b. 4/01/2021 c. 8/17/2021 d. 10/07/2021 e. 2/04/2022 f. 5/10/2022 g. 9/20/2022 2. A record review revealed for 2 (2021 and 2022) of 2 years that once the monthly quality control documents were printed the daily background counts were discarded and not retained for 2 years. 3. A record review revealed a lack of documentation of hematology quality control records and patient printouts from 1/04/2021 to 8/17/2021 were not available on the day of the survey. 4. An interview on 1/04/2023 at 1:08 pm, TP#1 confirmed the above listed Beckman Coulter DxH520 quality control records, patient printouts, and background counts were not available on the day of the survey. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interview with Testing Personnel (TP) #1, the laboratory failed to meet applicable analytic system requirements and correct identified problems. Findings include: 1. The laboratory failed to perform and document the refrigerator temperatures and perform and document thermometer calibrations. Refer to D5431 A & B. 2. The laboratory failed to perform quality control testing at least each day of patient testing for its hematology complete blood count. Refer to D5445. 3. The laboratory failed to document