Laboratory Corporation Of America

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) records for January 2026 and interview with the Laboratory Director (LD), the laboratory failed to ensure that QC was performed by all persons performing urinalysis on patient specimens. Findings include: 1. Upon review of QC records for urinalysis for January 2026, using Bio-Rad controls #1 & #2, lot numbers 79981 exp. 08/01/2026 and 79982 exp. 08/01/2026, it was revealed that one (1) of four (4) testing personnel (TP #1) performed the QC on the urine dipsticks twenty (20) days out of twenty six (26) working days in January 2026. 2. TP #2 performed QC on the urine dipsticks six (6) days out of twenty six (26) days in January 2026.. 3. TP #3 performed no QC on the urine dipsticks in January 2026. 4. TP #4 performed no QC on the urine dipsticks in January 2026. 5. Interview with the Laboratory Director (LD) at 2:30 pm confirmed these findings. 6. The laboratory reports performing 317 urinalysis tests annually. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and discussion with the staff the laboratory failed to follow written procedures for Quality Assessment (QA) / Patient Test Management. Findings include: 1. The surveyor requested and the laboratory failed to provide proof of documentations of ongoing quality assessment (QA) and patient test management for the year 2018 and 2019. The last documented QA was dated 11/1/2017. 2. The Laboratory Director concur with these finding 11/18 /2019 @ 14:00 PM. 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 --