Arkansas Heart Hospital Clinic Llc- Little Rock

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of temperature and humidity records, lack of documentation, and interview; the laboratory failed to document

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Through a review of the laboratory's "Chemistry Calibration and QC Policy", Chemistry Quality Control (QC) for January 2023, patient test records for January 2023, and interviews with laboratory staff, it was determined the laboratory reported patient's Sodium (NA) result when quality control was unacceptable. Survey findings include: A) Through a review of chemistry NA QC results for January 2023 it was determined that on 1/6/23 Biorad Multiqual lot# 45870 level 1 (acceptable range 111.6 to 116.4) at 6:51 a.m. was resulted as 118 with flags "2/3-2S?1-3S" and level 3 (acceptable range 151.8 to 163.8)was reported as 164 with a flag of "2/3-2/S. Level 1 was repeated at 07:01 a.m. as 119 with a flag "2-2S/2/3/3-2S/1-3S" and repeated at 07: 13 a.m. as 117 with a flag "1-2S. Records show that level 3 was not repeated on that date. B) A review of the laboratory test reports revealed that NA tests were performed and reported on 88 patients (identified as numbers 1 through 88 on a separate patient identification list) on 1/6/23. C) In an interview on 2/8/24 at 12:25 p.m. laboratory employee #1 (as listed on the form CMS-209) confirmed that on 1/6/23. QC for NA analysis was unacceptable and 88 patients had NA analysis performed and reported on that date D5779