Wellmont Health System

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on 08.21.2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services CASPER Report 155 (CMS 155) and the laboratory's proficiency testing (PT) evaluation 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 -- reports, the laboratory failed to maintain satisfactory participation for two consecutive proficiency testing events in 2023 and 2024, resulting in initial unsuccessful participation for the Creatine Kinase (CK) Isoenzyme. (See D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the CMS 155 and the laboratory's PT evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive test events for the Creatine Kinase (CK) Isoenzyme analyte, resulting in an initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 155 report revealed the following unsatisfactory CK Isoenzyme scores: - 2023 Event three: 0% - 2024 Event one: 0% 2. A review of the laboratory's College of American Pathologists (CAP) PT evaluation report revealed the following unsatisfactory CK Isoenzyme scores: - 2023 Event three: 0% - 2024 Event one: 0% -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records and an interview with the lab technical specialist, the laboratory director/designee failed to sign 19 of 29 attestation statements reviewed for 2023. The findings include: 1. A review of the laboratory's 2023 CAP PT records for Chemistry, Hematology, and Microbiology revealed the laboratory director/designee failed to sign 19 of the 29 attestation statements reviewed. 2. In an interview with the lab technical specialist on 01.31.2024 at 2:45 p.m. confirmed the laboratory director /designee failed to sign 19 of the 29 PT attestation statements reviewed for 2023. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records and an interview with the lab technical specialist, the laboratory failed to retain the PT attestation statement for two years for one of 29 PT events reviewed from 2023. The findings include: 1. A review of the laboratory's CAP PT records revealed the laboratory did not retain the attestation statement for blood oximetry 2023 event two. 2. In an interview with the lab technical specialist on 01.31.2024 at 2:45 p.m. confirmed the laboratory failed to retain the PT attestation statement for at least two years for one of 29 PT events reviewed from 2023. -- 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: =================================== Based on review of the HCH Laboratory Services Temperature (and Humidity) Chart and interview with the lead laboratory technologist, it was determined that the laboratory failed to ensure the humidity was maintained at 30-80% for five of 23 months reviewed in 2020, 2021, and 2022. The Findings include: 1. Review of the Temperature (and Humidity) Chart revealed the humidity was out of the defined range (30-80%) in the year 2021 for the following months: -November (3 of 30 days) in the year 2022 for the following months: -January (3 of 31 days) -February (3 of 28 days) -March (2 of 31 days) -April (2 of 30 days) 2. An interview with the lead laboratory technologist on May 23, 2022 at approximately 12:15 pm confirmed the laboratory failed to ensure the humidity was within acceptable range in 2021 and 2022. =================================== 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 --