Redmed Of Arlington, Llc

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on laboratory observation and staff interview, the laboratory failed to ensure microtainer tubes used to collect fingerstick samples for Complete Blood Count with automated White Blood Cell Differential (CBC w/Diff) testing were not expired on the date of the survey (12/02/24). The findings include: 1. Laboratory observation on 12/02/24 at 8:43 a.m. revealed the Sysmex XP-300 instrument (serial #C4845) used for performing patient testing for CBC w/Diff. Microtainer tubes used for collecting fingerstick patient samples for CBC w/Diff were observed with a lot number of 22E4466 and an expiration date of 05/31/24. 2. The technical consultant confirmed the survey findings during an interview on 12/02/24 at 1:30 p.m. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of testing personnel records, patient test reports, and interview with the laboratory director, the laboratory director failed to ensure testing person number six received training and demonstrated accuracy prior to reporting patient test results in 2021. The findings include: 1. Review of testing personnel records revealed no documentation of training and demonstration of accuracy for testing person number six. 2. Review of patient test reports revealed seven patients were reported independently by testing person number six since employment began (patient chart numbers 120284, 94565, 142343, 201710, 198923, 198492, 81790). Dates tested spanned from 06.09.2021 to 09.08.2021. 3. Interview with the laboratory director on October 7, 2021 at 1:30 pm confirmed the laboratory director failed to ensure testing person number six received appropriate training and demonstrated accuracy prior to performing patient testing in 2021. 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 D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the 2018 complete blood count (CBC) quality control (QC) records, the CBC QC manufacturer instructions and interview with the laboratory director, the laboratory failed to identify and correct that the new lot number platelet QC mean was entered incorrectly into the instrument on August 16, 2018. The findings include: 1) Observation of the laboratory on December 17, 2018 at 1:15 p.m. revealed the Beckman Coulter AcTdiff CBC instrument (serial number BB12022) in use for patient testing. 2) Review of the 2018 CBC QC records revealed on August 16, 2018 a new lot number (088000) low CBC QC was entered with incorrect platelet mean value of 80. 3) Review of the November 2018 CBC QC summary report revealed on December 1, 2018 technical consultant numbers one, two and three performed quality assessment review but failed to identify the platelet mean for lot 088000 was incorrect. 4) Review of the CBC QC manufacturer package inserts for acceptable means and limits revealed lot number 77700 platelet mean of 75 was since in use with the 088000 platelet mean, from August 16, 2018 to November 4, 2018. 5) Interview on December 17, 2018 at 3:30 p.m. confirmed on August 16, 2018, technical consultant number two changed the lot number 088000 low QC but the platelet mean was not changed from the previous lot number and that the December 1, 2018 quality assessment review did not identify and correct the error. 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 --