Uams-South Central

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: . Through a review of the Casper 0096D report, proficiency testing records, lack of documentation and interview with staff, it was determined the laboratory failed to provide the proficiency testing organization with the CLIA certification number to allow for reporting of Proficiency testing results to Arkansas Department of Health (ADH) for two of two proficiency testing events in 2021 Survey Findings follow: A. A review of Casper 0096D report for UAMS South Central revealed no proficiency testing scores for the Hematology, Chemistry and Endocrinology in 2021 for two of two proficiency testing events. B. A review of American Proficiency Institute (API) performance summary for the first and second Proficiency testing event of 2021 revealed "CLIA number not on file" for UAMS South Central Laboratory. C. Upon request the laboratory could not provide documentation that the proficiency testing results for two of two testing events in 2021 had been reported to ADH. D. In an interview on 7/17/2021 at 10:30, laboratory personnel #3, stated the laboratory changed proficiency testing program in December of 2020 from CAP to API and failed to report the CLIA number to API resulting in the proficiency testing score not being transmitted to ADH. 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 D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Through a review of the laboratory "Policy and Procedure Manual", observations made during a tour of the laboratory, and interviews with laboratory staff, it was determined the laboratory failed to follow written policies for positive identification of urine specimens. As evidenced by: A. A review of the laboratory policy for labeling urine specimens revealed "Urine cups given to the patient for specimen collection will be labeled with the patients first initial, last name, date of birth and time of collection." B. During a tour of the laboratory, at 0930 on 4/4/2019, the surveyor observed of six urine containers in the laboratory sink. Three of six urine containers were labeled with the patients first and last name only. C. In an interview at 0930 on 4/4/2019, laboratory personnel #3 (as listed on form CMS 209) confirmed the urine containers were not labeled according to laboratory policy. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Through a review of the laboratory policy and procedure manual, quality control data for November 2018, January and March 2019, lack of documentation as well as interviews with staff, it was determined the laboratory failed to monitor over time the accuracy and precision of test performance. As evidenced by: A. A review of the laboratory's policy and procedure manual revealed "Shifts and trends should be watched for and