Kc Bariatric, Llc

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of CMS form 209, competencies, and interview, the technical consultant (TC) failed to evaluate and document competency at least semiannually during the first year the individual tests patient specimens for three of five testing personnel (TP). Findings: 1. Review of the site's CMS for 209 for personnel revealed five new testing personnel since last survey. 2. Review of personnel competency records revealed no semiannual compentencies during the first year for TP#2, TP#3, and TP#5. 3. Interview with the laboratory director, who is also the TC on 5/8/23 at 9: 30 a.m. confirmed, the TC failed to evaluate and document competency at least semiannually during the first year the individual tests patient specimens for three of five TP. 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 D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with technical consultant #1 (TC#1), the laboratory failed to include the name and address of the laboratory location where the test was performed on the patient report. Findings: 1. Review of selected patient test reports showed the laboratory name and address where the test was performed was not present on the report. 2. Interview with TC#1 on 8/26/21 at 10: 00 a.m. confirmed the laboratory failed to include the name and address of the laboratory where the test was performed on the patient report. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: 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 -- Based on review of approved reference ranges in the laboratory procedure manual and interview with the laboratory director (LD), the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. Findings: 1. Review of the patient reports from the LIS system revealed eight of the eight parameters for normal ranges did not correctly match those reference ranges for the complete blood count (CBC) test in the procedure manual. LIS patient report Procedure manual WBC 4.5-10.5 3.71-10.67 RBC 4.00-6.00 3.87-5.68 HGB 11.0- 18.0 12.00-16.75 HCT 35.0-60.0 35.1-48.7 MCV 80.0-99.0 78.4-97.6 MCH 27.0-31.0 26.5-33.5 MCHC 32.8-37.0 32.9-35.4 PLT 150-450 150.5-366.8 2. Interview with LD on 8/26/2021 at 11:00 a.m. confirmed, the laboratory failed to ensure correct reference ranges approved in the procedure manual were included on the LIS patient report. -- 2 of 2 --