Summary:
Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of the Accession Log (AL), Raw Data (RD), Final Reports (FR) and interview with Testing Personnel (TP), the laboratory failed to maintain an information or record system for Hematology tests performed from 1/30/26 to 5/5/26. The findings include: 1. One out of ten patient test records reviewed, the patients name and demographics on the AL did not match the RD or FR. 2. TP #2 as listed on the CMS 209 form confirmed on 5/5/26 at 12:00 pm, the laboratory did not have an information or record system that ensured positive patient identification through all phases of Hematology testing performed. Note: This deficiency was corrected on site. 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 --