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 patient testing log, patient final testing reports (electronic medical records (EMR), and interview with the laboratory personnel, it was determined that from 11/15/2018 through 02/03/2020 for five (5) 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 mineral oil test results in the patient testing log (PTL) and the patient medical record (MR) it was found that the patient test results were not reported in the patients' medical records. Date Pt MRN PT Log Medical Record 11/15/18 13976 (+) NR (no results) 01/25/19 17003 (-) NR (no results) 04/18/19 36734 (+) NR (no results) 08/09 /19 1678 (-) NR (no results) 02/03/20 14586 (+) NR (no results) b. On 02/13/2020 12: 00 pm (survey date), the laboratory personnel affirmed that the patient testing results could not retrieve in the patient medical records. c. Based on the laboratory's annual test volume declaration (02/12/2020) the laboratory performed 600 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 --