Uams Regional Programs Jonesboro

Summary Statement of Deficiencies D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Through observations made during a tour of the laboratory and interviews with laboratory staff, it was determined the laboratory failed to ensure confidentiality of patient information by having patient information on a video screen within view of the patient drawing chair. Survey findings include: A. During a tour of the laboratory, at 9: 50 on 11/2/2022, the surveyor observed a large video screen on the wall of the laboratory within sight of the chair where patients sit to have their blood drawn. The video screen listed patients who were in the clinic and included the patient first initial and last names. B. During an interview at the time of the laboratory tour, laboratory employee #3 (as listed on the form CMS-209) confirmed that patient information is visible to anyone having blood drawn in the laboratory. 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: Through observations made during a tour of the laboratory and interviews with laboratory staff, it was determined the laboratory had Vacutainer tubes available for use when they had exceeded their expiration date. Survey findings include: A. During 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 -- a tour of the laboratory, at 9:50 a.m. on 11/2/2022, the surveyor observed ten 3.0 ml K2 EDTA Vacutainer tubes (lot # 1074752) in the test tube rack on a table beside the blood drawing chair. The Vacutainer tubes had an expiration date of 7/31/2022. B. In an interview at 9:50 a.m. on 11/2/2022, laboratory personnel #3 (as listed on the form CMS-209) confirmed the expired Vacutainer tubes were available for use when they had exceeded their expiration date. -- 2 of 2 --

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: Through review of Celldyne 1800 data logs, quality control reports, lack of documentation and interview it was determined that the laboratory reported patient CBC (complete blood cell count) results without performing required quality control on one of 18 days of operation in July 2017. Findings follow: A. Review of Celldybe 1800 data log revealed that complete blood cell counts were performed and reported on patient 431497247 and patient 76702 on Monday, 07/28/17 with no evidence of quality control being performed on that day. B. Review of the quality control report for July 2017 revealed no evidence of quality control being peformed on 07/28/17. C. Upon request, the laboratory was unable to produce a record of quality control procedures being performed on 07/28/17. B. In an interview on 05/09/18 at aproximately 1600 the technical consultant identified as number 2 on the CMS 209 form confirmed that CBC's were run and reported on 07/28/17 without the required quality control being performed. D5781