Summary:
Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on lack of test requisition documentation for review and interview with the technical consultant (TC), the laboratory failed to have a written or electronic request for ACT (Activated Clotting Time) testing for two out of two patient records reviewed during the survey. Findings include: 1. No written or electronic request for ACT testing was presented for review for two of two patient records reviewed during the survey, patient# 301087 tested on 5/13/22 and patient# 313787 tested on 01/07/24. 2. The TC interviewed on August 28, 2024 at 2:33 PM confirmed the laboratory failed to have an electronic or written test requisition for testing that was performed on the patients indicated above. 3. The laboratory performs 50 tests annually under the specialty of Hematology. D5803 TEST REPORT CFR(s): 493.1291(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: Based on review of laboratory policy, review of patient test reports maintained in the electronic medical record (EMR) and interview with the technical consultant (TC), the laboratory failed to provide evidence of the test report for one out of two patient records reviewed during the survey. Findings include: 1. The laboratory performs 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 -- ACT testing in the specialty of Hematology, with an approximate annual test volume of 50. The laboratory utilizes an electronic medical record (EMR) system to maintain patient test reports. 2. The laboratory's reporting policy for ACT testing states, "The iStat result tape will be attached to the Lab Report Form... The Lab Report Form will be scanned into the patient's electronic record." 3. The laboratory failed to produce evidence of the ACT test report in the EMR for one out of two patient records reveiwed, patient# 301087 for testing performed on 5/13/22. 4. The TC interviewed on August 28, 2024 at 2:23 PM confirmed the laboratory failed to scan the test results to the EMR for the patient indicated above. -- 2 of 2 --