Summary:
Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of the patient testing log on 06/22/2021 at 10:30 a.m., patient final testing reports (electronic medical records (EMR), and interview with the laboratory staff, it was determined that from 11/85/2019 through 06/16/2021 for one (1) out of ten (10) random patient testing records reviewed, the laboratory failed to follow written policies and procedures for specimen collection, through completion of testing and reporting results. The findings included: a. Review of patient KOH (potassium hydroxide) and wet mount results in the patient testing log (PTL) and the patient medical record (MR) it was found that the patient test result was not reported in the patient's medical records. Date Pt ID/site PT Log Medical Record 07/10/20 RF/L Elbow (-) NR (no results) b. On 06/22/2021 11:30 a. m. (survey date), the laboratory personnel affirmed that the patient testing result could not retrieve in the patient medical records. c. Based on the laboratory's annual test volume declaration (06/22 /2021) the laboratory performed 174 KOH and mineral oil patient testing. 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 --