Unity Health Searcy Medical Center

Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel files for all testing personnel listed on the CMS-209 form, lack of documentation, and interviews with laboratory staff, determined the laboratory director failed to authorize two of six testing personnel to perform testing without direct supervision. Survey findings include: A) During a review of personnel files for all testing personnel (TP), TP- 1 and TP- 2 (as listed on the form CMS-209) failed to have written authorization from the laboratory director, to perform moderate complexity for the new Sysmex XN-530 hematology instrument without direct supervision. B) In an interview on 8/7/2025 at 2:20 pm, the TP-1on the CMS 209 form confirmed the lack of written authorization for two TP on form CMS 209. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Through a review of proficiency test results and

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Interviews with laboratory staff and lack of documentation, determined the laboratory failed to retain instrument maintenance records for at least 2 years. Survey findings follow: A. On an initial tour of the laboratory on 3/12/19 at approximately 09:30 AM, Vitros 5.1, Vitros ECI and Vitros 5600 chemistry instruments were observed in the chemistry section of the laboratory. B. In an interview on 3/12/19 at approximately 09: 30 AM, when asked about which tests were performed on each instrument, the laboratory manager, identified as number 1 on a separate staff identification sheet, and the technical consultant, identified as number 2 on the CMS 209 form, stated that since June 2018 all chemistry tests are performed on the Vitros 5600. The Vitros 5.1 and the Vitros ECI were used for testing in 2018 until replaced by the Vitros 5600 in June 2018. C. On 3/14/19 at 10:30 AM the surveyor requested maintenance documentation for the chemistry instruments Vitros 5.1, Vitros ECI and Vitros 5600 for the calendar year of 2018. B. In an interview at 10:45 AM on 3/14/19, the laboratory manager, identified as number one on the separate staff identification list, stated that the instrument maintenance records for 2018 for the Vitros 5.1 and Vitros ECI could not be located and were unavailable. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Through review of manufacturer's package inserts, "Laboratory Policy and Procedure: Vitros Chemistry Analyzer Quality Control", Quality Control Reports, patient result reports, previous survey findings, lack of documentation and interview it was determined that the laboratory failed to meet analytic systems requirements or monitor and correct problems in the analytic systems, even though elements were cited on the previous survey conducted on 8/24/17, as evidenced by: D5441 - The laboratory failed to employ a method to detect assay error over time; D5469- The laboratory failed to establish its own quality control acceptable range as required by the manufacturer's package insert. D5481 - The laboratory reported patient results when quality control failed to meet criteria for acceptability. This deficiency was previously cited in the survey conducted on 8/24/17. 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 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 review of the laboratory's "Quality Control Reports", the "Laboratory Policy and Procedure: Vitros Chemistry Analyzer Quality Control", lack of documentation, and interview it was determined that the laboratory failed to employ an effective method for detecting errors over time in quality control performance , such as shifts or trends for chemistry testing. This has the potential of affecting all chemistry testing. Findings follow: A. Review of the laboratory's "Quality Control Report" for total bilirubin (TBil) assays for February 2018 revealed that Performance Verifier level 1 (PV1) lot# T5608 expiration date 3/1/19 was recorded as resulting below the target /mean on twenty-four of twenty-four consecutive runs; and Performance Verifier 2 (PV2) lot# U5612 expiration date 3/1/19 was recorded below the target/mean on twenty-four of twenty-four consecutive runs. B. Review of the laboratory's "Quality Control Report" for Albumin (ALB) assays for February 2018 revealed that Performance Verifier level 1 (PV1) lot# T5608 expiration date 3/1/19 was recorded as resulting below the target/mean on sixteen consecutive runs from 2/8/18 through 2/28 /18; and Performance Verifier 2 (PV2) lot# U5612 expiration date 3/1/19 was recorded below the target/mean on sixteen consecutive runs from 2/8/18 through 2/28 /18. C .Review of the laboratory's "Quality Control Report" for Triglyceride (TRIG) assays for August 2018 revealed that PV1 lot# W5903 expiration date 6/26/19 was -- 2 of 5 -- recorded as resulting below the target/mean on thirteen consecutive runs from 8/13/18 through 8/31/18; and PV2 lot# U5612 expiration date 3/1/19 was recorded below the target/mean on twenty-three of twenty-three runs from 8/1/18 through 8/31/18. D. Review of the "Laboratory Policy and Procedure: Vitros Chemistry Analyzer Quality Control" revealed that "the problems that will be evident on the QC charts are excessive scatter, test bias, drifting of results, shifting of results or a trend" and "document all actions taken on the appropriate instrument troubleshooting log" and no definition of what constitutes "drifting of results, shifting of results, or a trend" was present. E. Upon request, the laboratory was unable to produce a Levey-Jennings Chart or other method of determining changes in test performance over time or documentation that a shift or trend had been recognized and

Summary Statement of Deficiencies D0000 On 02/09/18 at 8:55 AM, an entrance conference was conducted with Facility Representatives. The facility was informed the purpose of the visit was to conduct a Medicare complaint survey. On 02/09/18 at 10:45 AM, an exit conference was conducted with Facility Representatives. The findings of the survey were discussed. The Facility Representatives were given an opportunity to present additional information for the findings discussed. No additional information was presented. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of laboratory complaint policy, laboratory Incident Reports, and interviews with laboratory staff, it was determined the laboratory failed to conduct investigations to identify and correct problems when complaints were reported to the laboratory. The failed practice created the potential for complaints to go unaddressed and could affect any patient needing laboratory services. Survey findings follow: A. The laboratory complaint policy stated, "All complaints from provider's or patients will be documented. An investigation will be done to assess the validity of the complaint or to resolve valid complaints.