Laboratory Corporation Of America Holdings

Summary Statement of Deficiencies D6074 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(5) Each individual performing moderate complexity testing must be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the technical consultant, clinical consultant or director. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, review of 2023 and 2024 urinalysis quality control records, and interview with the TC (technical consultant) 9/5/24, testing personnel failed to recognize that a problem existed when incorrect quality control ranges were documented for urine microscopic controls on 186 days of testing from 11/1/23 - 8/16/24, and unacceptable results were obtained on 5 of the 186 days. Findings: Review of the product insert for the BIO-RAD qUAntify Plus Control Levels 1 and 2 revealed "... ASSIGNMENT OF VALUES The results printed in this insert were derived from replicate analyses and are specific for this lot of product. ..." Review of the laboratory's 2023 and 2024 "URINALYSIS DAILY QUALITY CONTROL LOG" revealed the laboratory had used BIO-RAD qUAntify Plus Control Level 2, lot #80802 from 11/1/23 - 8/16/24. 1. The quality control product insert listed the acceptable range for microscopic WBC (white blood cell) count on the Level 2 control as 10-50 cells per hpf (high power field), but the "URINALYSIS DAILY QUALITY CONTROL LOG" listed the acceptable range as 0-60 cells per hpf. Unacceptable WBC results were documented 2/22/24, 2/23/24, 6/3/24, 6/4/24, and 6/5 /24 for the Level 2 control. 2. The quality control product insert listed the acceptable range for microscopic RBC (red blood cell) count on the Level 2 control as 10-60 cells per hpf (high power field), but the "URINALYSIS DAILY QUALITY CONTROL LOG" listed the acceptable range as 0-40 cells per hpf. Unacceptable RBC control results were documented 2/22/24 and 2/23/24 for the Level 2 control. During interview at approximately 2:30 p.m., the TC stated the laboratory must have Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- continued to use the ranges from the previous lot number of control material instead of updating the ranges when they started using the new lot number. -- 2 of 2 --

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 and interview with TP (testing personnel) on 7/10/2019, the laboratory failed to discard a mononucleosis(Mono) test kit that had exceeded its expiration date. Findings: During tour of the laboratory at approximately 12:30 pm, the surveyor observed an expired Monolex system kit (lot #229841, expiration date: 5 /14/19) stored in the refrigerator, that was available for use. During interview at approximately 12:35 pm, TP #1 confirmed the Monolex kit was expired. She stated Mono testing is not performed very often. D5785