Chi St Vincent Cancer Center

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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: Through review of personnel competency records for four testing personnel listed on the CMS 209 form, authorizations to perform tests, and interview, it was determined that the laboratory did not assess the competency of one of four testing personnel semi-annually during the first year of employment. Findings follow: A) Review of personnel records of testing personnel ( number 4 on the CMS 209 form) indicated that the employee began employment in May 2024 and authorized by the laboratory director to perform moderately complex Complete Blood Cell (CBC) testing without direct supervision. Competency assessments for CBC testing were dated 5/10/24 and 8 /1/25 which did not meet the requirement of twice annual competency assessment during the first year of employment. B) In an interview on 2/12/26 at 09:15 a.m. the laboratory staff member (number 1 on the form CMS 209) verified that competency evaluation was not performed semi-annually during the first year of employment for the testing personnel identified as number 4 on the CMS 209 form.. 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: Through review of the CMS 116 form, observation, review of test result reports, the laboratory referred test log and interview with laboratory staff it was determined the correct name and address of the laboratory performing the test was not present on the test report for three of three routine chemistry tests referred by the laboraatory . This would have affected all of the approximate 80 tests per month referred by the laboratory. Survey findings follow: A) Review of the CMS 116 form provided by the laboratory revealed that no routine chemistry tests were listed on the CMS 116 form as being performed by the laboratory, B) In a tour of the laboratory on 1/7/20 at approximately 08:30 AM, no laboratory instrumentation capable of performing routine chemistry analysis such as those on a Basic Metabolic Panel was observed in the laboratory. C) In interview on 1/2/20 at approximately 08:30 AM, the technical consultant identified as number 2 on the CMS 209 form stated that the all chemistry tests are referred to an outside laboratory. D) Review of Basic Metabolic Panel test results performed on 10/15/2019 for patient identified as number 1 on the patient identification list, the Basic Metabolic Panel test results performed on 10/15/2019 for patient identified as number 2 on the patient identification list and the Basic Metabolic Panel test results performed on 1/2/2020 for patient identified as number 3 on the 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 -- patient identification list revealed that all the reports listed the performing laboratory as "CHI SV Oncology Clinic-LR 1 St. Vincent Cir STE 220, Little Rock, AR 72205- 5405". E) Review of the laboratory referred test log revealed that approximately 80 chemistry tests per month are referred by the laboratory. D) In an interview on 1/7/20 at approximately 11:30 AM the technical consultant, identified as number 2 on the CMS 209 form, confirmed that the name and address of the performing laboratory is incorrect on the final result of routine chemistry tests referred by the laboratory. -- 2 of 2 --