Nea Baptist Clinic Paragould

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Through a review of the new instrument validation documentation for the moderate complexity chemistry tests performed on the Abbott I-Stat, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to validate the precision of the new test system. Survey findings include: A. During a review of the validation documentation for the Abbott I-Stat, it was determined the standards used for validation of accuracy and reportable range were only analyzed once each. Multiple runs of the same standard are required to calculate CV% which is a measure of precision. B. The surveyor requested documentation of validation of the precision but none was available for review. C. In an interview at 9:52 a.m. on 1/20 /2021 laboratory employee #3 (as listed on the form CMS-209) confirmed the lack of documented validation of the precision for the Abbott I-Stat. 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 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 -- 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: Through a review of the Individualized Quality Control Plan (IQCP) for moderate complexity chemistry tests performed using the Abbott I-Stat analyzer and through interviews with laboratory staff, it was determined the IQCP failed to include all three required components. Survey findings include: A. During a review of the IQCP for the Abbott I-Stat chemistry analyzer, the surveyor determined the IQCP consisted of a risk assessment and quality control plan, but did not include the required quality assessment component of the IQCP. B. In an interview at 10:20 on 1/20/2021, laboratory employee #3 (as listed on the form CMS-209) confirmed the lack of quality assessment component in the IQCP for the Abbott I-Stat. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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: Through observation, lack of documentation, and interview it was determined that the laboratory failed to monitor and document room temperature in one of two rooms in which laboratory supplies with storage temperature requirements were stored. Findings follow: A. During a tour of the laboratory on 4/11/18 at approximately 0930 AM, 400 ea. 8.5 ml BD SST vacutainers lot# 7299077 expiration date 2018-10-31 and a storage temperature of 4degrees C. to 25 degrees C. and three boxes of 50 BD Universal Viral Transport tubes lot # 1800200000291, an expiration date of 2019-07- 31, with a storage temperature requirement of 2 degrees C. to 25 degrees C. were observed in a separate storage room with a closable door. B. Upon request, the laboratory was unable to provide documentation of temperature meansurements of the storage room. C. In an interview on 4/11/18 at approximately 11:30 AM, the technical consultant identified as number 3 on the CMS 209 form confirmed that supplies with storage temperature requirements were stored in the separate storage room and room temperature was not monitored and documented. 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 --