Summary:
Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) (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 the Electronic Medical Records (EMR), Manual Accession Log (MAL) and interview with the Techincal Consultant (TC), the laboratory failed to ensure that laboratory results are accurately and reliably transcribed into the EMR for Throat Culture tests from 3/31/25 to 9/16/25. The findings include: 1. Two out of ten test results in the EMR did not have final result times for Throat Culture (TC). 2. The TC confirmed on 3/18/25 at 12:00 pm, the laboratory failed to ensure that laboratory results were accurately and reliably transcribed into the EMR D5803 TEST REPORT CFR(s): 493.1291(b) (b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. 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 the surveyor review of Work Records (WR), Final Reports (FR) and interview with the Techincal Consultant (TC), the laboratory failed to have medical records readily available. The finding includes. 1. One out of ten FR reviewed on 9/16 /25 was missing. 2. The TC confirmed on 7/30/25 at 1:00 pm that the laboratory did not maintain all FR. -- 2 of 2 --