Children's Physicians - Lavista

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on surveyor review of complete blood count instrument print out test records, electronic health record system, and interview with the technical consultant revealed the laboratory failed to ensure test results are accurately reported. 1. Review of complete blood count instrument print out test records from January 2022 to July 2022 revealed two instrument print out test records, testing performed on 3/16/2022 and 4/27/2022, with only one patient identifier, medical record number (MRN). 2. A search of the electronic health record system using the MRN recorded on the instrument print out from testing performed on 3/16/2022, revealed the MRN belonging to a patient that did not have complete blood count testing performed on 3 /16/2022. 3. A search of the electronic health record system using the MRN recorded on the instrument print out from testing performed on 4/27/2022, revealed complete blood count results that did not match with the instrument print out test record. 3. Interview with the technical consultant on 7/15/2022 confirmed the laboratory failed to accurately report patient results. D5819 TEST REPORT CFR(s): 493.1291(j) 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 -- All test reports or records of the information on the test reports must be maintained by the laboratory in a manner that permits ready identification and timely accessibility. This STANDARD is not met as evidenced by: Based on surveyor record review and interview with the technical consultant the laboratory failed to maintain complete blood count instrument print out test records in a manner that permits identification and accessibility. Findings are: 1. Review of complete blood count instrument print out test records from January 2022 to July 2022 revealed two instrument print out test records with incomplete patient identification. 2. The two instrument print out test records revealed only one patient identifier, medical record number. 3. Interview with the technical consultant on 7/15 /2022 confirmed the two instrument print out test records had only one patient identifier. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of Complete Blood Count (CBC) procedure, surveyor review of Complete Blood Count (CBC) patient results log, surveyor review of patient test reports, and interview with laboratory director the laboratory failed to follow its own procedure of reporting patient test results. Findings include: 1. Based on review of laboratory's Complete Blood Count (CBC) procedure, the procedure indicates "Never report a flagged result. If a 2 letter flag displays in front of a result, do not report this result as it is not reliable. Type NRE on the result line. NRE = No Results Expected." 2. Review of 2020 Complete Blood Count (CBC) patient results log revealed four patients with a two letter flag. Review of those four patient's test report revealed a result reported. 3. Interview with the laboratory director on 10/21/2020 at 11:50 AM confirmed the laboratory's Complete Blood Count (CBC) procedure was not followed. 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 D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of