Summary:
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 observation of the laboratory, review of the 2017 complete blood count a (CBC) quality control (QC) records and interview with the technical consultant, the laboratory failed to ensure the CBC QC was not in use after the expiration date. The findings include: 1) Observation of the laboratory on August 7, 2018 at 1:00 p.m. revealed the Beckman Coulter AcT Diff 2 instrument system identification number 1278503 in use for patient testing. 2) Review of the 2017 CBC QC records revealed on June 8, 2017 lot number 089000 expiration date 6-6-17 in use. 3) Interview on August 7, 2018 at 2:15 p.m. with the technical consultant confirmed patient testing was performed on June 6, 2017 with expired CBC QC in use. 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 --