Kc Bariatric

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 proficiency testing (PT) from the provider American Proficiency Institute (API) performed in 2021 and 2022 and interview with Laboratory Director (LD) revealed that the LD or approved designee failed to attest on three events that proficiency testing samples were handled in the same manner as patient samples at time of survey. Findings: 1. Review of the attestation page for the PT from API revealed no signature of the LD or approved designee was present on API 2021 event for Chemistry Core 3rd Event 2. Review of the attestation pages for the PT from API revealed no signatures of the LD or approved designee was present on API 2022 events: a. Chemistry Core 1st Event b. Chemistry Core 2nd Event 2. Interview with the LD on 10/6/2022 at 10:30 a.m. confirmed, the laboratory director (LD) or approved designee failed to attest on three events that proficiency testing samples were handled in the same manner as patient samples at time of survey. 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 D3003 FACILITIES CFR(s): 493.1101(a)(2) The laboratory must be constructed, arranged, and maintained to ensure contamination of patient specimens, equipment, instruments, reagents, materials, and supplies is minimized. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory director, the laboratory failed to minimize contamination of reagents, equipment and patient samples. Findings: 1. Observation of the laboratory area revealed approximately 495 cases of patient vitamins stored near patient samples, reagents, and laboratory equipment. 2. Interview with the laboratory director on December 7, 2018 at 11:30 AM confirmed the owner stores the vitamins for patient use within the laboratory testing area. 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 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: Based on review procedures and interview with the laboratory director, the laboratory failed to include a specimen acceptability, step by step procedure for the chemistry and hematology analyzer (refer to 05403); failed to follow the manufacturer's 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 -- guidelines for reagent and specimen stability (refer to 05411); failed to store reagents appropriately (refer to 05412). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)