Southern Cancer Center

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on an observation in the laboratory, a review of the Audit MicroControls Linearity FD Bilirubin Supplement package insert, and an interview with the Technical Consultant, the laboratory failed to adhere to conditions of storage for reagents. The findings include: 1. During the laboratory tour, the surveyor observed an unopened box of Audit MicroControls Linearity FD Bilirubin Supplement stored in a freezer set at -20 degrees Celcius. 2. A review of the Audit MicroControls Linearity FD Bilirubin Supplement package insert revealed the storage requirements of 2 to 8 degrees Celcius. 3. During an interview on 09/13/2022 at 9:45 AM, the Technical Consultant confirmed the above findings. 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 D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on reviews of the laboratory test menu, the IQCP (Individualized Quality Control Plan) for the Piccolo Xpress, the Piccolo quality control (QC) data, patient test volumes and an interview with Testing Personnel #1 (also the Laboratory Manager), the surveyor determined the laboratory failed to ensure both levels of QC (performed every 30 days and each new lot number) on the BMP (Basic Metabolic Profile) cartridges were within acceptable ranges. One level of Potassium (K+) QC was outside acceptable ranges for six out of 24 months of the 2016-2017 QC reviewed. The findings include: 1. A review of the laboratory menu revealed Chemistry testing was performed using patients' plasma samples on the Piccolo Xpress (a moderate-complexity test.) 2. A review of the QC for the Piccolo revealed the laboratory had previously implemented an IQCP on 12/18/2015 which specified personnel should perform QC every 30 days, and with each new lot number (#) of cartridges. 3. A review of the 2016-2017 Piccolo BMP cartridge QC data revealed the K+ QC was outside acceptable ranges for multiple lot numbers of cartridges for six months with no documentation of effective investigation or