Kearney Regional Medical Center

Summary Statement of Deficiencies 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 desk review of proficiency testing for 2020, the laboratory failed to achieve satisfactory scores for the chemistry analyte, lactate dehydrogenase, total (LDH), for the 2020 second and third event. 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 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing for 2020 and the laboratory's graded proficiency testing results from American Proficiency Institute this laboratory had unsatisfactory performance for the analyte lactate dehydrogenase, total (LDH). Findings are: 1. 2020 second event, score 0% 2. 2020 third event, score 0% -- 2 of 2 --

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on lack of documentation the laboratory failed to have proof of education on six testing personnel performing moderate complex point of care (POC) testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of moderate complexity testing personnel qualifications, lack of 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 -- documentation, and interview with general supervisor, on 8/13/2019 at 1:15 PM the laboratory failed to have proof of education on six out of fifty five testing personnel performing moderate complexity point of care (POC) testing. Findings are: 1. Review of fifty five moderate complexity personnel files revealed six moderate complexity testing personnel had no proof of education documentation. 2. Interview with general supervisor, confirmed no documentation was available on time of survey. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as 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 result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of moderate complexity testing personnel files, lack of documentation, and interview with the general supervisor at 1:15 PM on 8/13/2019, the laboratory failed to have responsibilities and duties signed by the current lab director for thirty eight testing personnel performing moderate complexity point of care (POC) testing. Findings are: 1. Review of fifty five moderate complexity personnel files revealed thirty eight testing personnel performing moderate complexity point of care (POC) testing did not have responsibilities and duties signed by the current lab director. 2. No documentation could be presented with the current lab director approval of responsibility and duties for these thirty eight personnel. 3. Interview with the general supervisor confirmed the responsibilities and duties had not been signed by the current director for these thirty eight testing personnel. -- 2 of 2 --