Alliance Cancer Specialists, Pc

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation the laboratory microscope and interview with Testing Personnel (TP) #1, the laboratory failed to perform maintenance for 1 of 1 Olympus CH -2 microscope in 2020. Findings include: 1. On the day of survey, 11/19/2020, observation of the laboratory microscope revealed, the service sticker on 1 of 1 Olympus CH -2 microscope was due for annual maintenance on 10/20/2020. 2. TP#1 confirmed the finding above on 11/19/2020 around 10:15 am. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the Beckman Coulter Ac T Diff 2 records and interview with testing personnel (TP) #1, the laboratory failed to evaluate the relationship between 2 of 2 Beckman Coulter Ac T Diff 2 hematology analyzers in 2018, 2019 and 2020. Findings include: 1. On the day of survey, 11/19/2020, the laboratory could not Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- provide comparison studies performed on 2 of 2 Beckman Coulter Ac T Diff 2 hematology analyzers in 2018, 2019 and 2020. 2. TP #1 confirmed the finding above on 11/19/2020 around 09:45 am. D5785

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory procedure manual (PM), manual differential (MD) quality control (QC) log, and interview with the testing personnel (TP) #1, the laboratory failed to document MD staining QCs in May 2018. Findings include: 1. The laboratory follows automatic stainer PMs (Laboratory Director signed off on 05 /2018) to stain MD slides. 2. The laboratory MD staining QC log (1st week of May 2018) showed the laboratory tested 2 MD specimens, from which a summary reads as follows: Date Specimen TP # Staining QC 05/01 1 2 No Record 05/03 1 3 No Record 3. Total 2 MD tested (05/01-03/2018), but none (2 of 2) had staining QC records. 4. The laboratory reported these 2 MD test results electronically. 5. The TP #1 confirmed above findings on 06/01/2018 at 10:30 AM. 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 --