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 laboratory's patient log and interview with the laboratory staff, the laboratory did not establish and follow policies and procedures to ensure positive identification of dermatophyte (DTM) specimens from the time of collection through completion and reporting of patient results. Findings: 1. Specimens collected for DTM testing are documented on a patient log upon receipt into the laboratory. 2. A review of patient logs from 12/8/16 to 10/18/18 showed that 23 of 29 patients did not include a unique patient identifier to ensure positive identification and optimum specimen integrity from the time of collection through result reporting. 3. During an interview on 11/21/18 at 9:45 AM, the laboratory staff confirmed that a unique second identifier is not currently documented on the patient log for DTM specimens received into the laboratory. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. 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 3 -- Based on quality control (QC) record review and interview with the laboratory staff, the laboratory failed to ensure that the expiration dates of media used for dermatophyte testing were documented. Findings: 1. The laboratory performs dermatophyte testing using Acuderm Dermatophyte Test Media. The laboratory saves the "Certificate of Conformity Quality Control" sheets included with each shipment of dermatophyte test media which attests that QC has been performed on each batch of media. 2. A review of "Certificate of Conformity Quality Control" sheets from 2017 and 2018 showed that there was only one sheet available at the time of the survey. 3. During an interview on 11/21/18 at 9:45 AM, the laboratory staff confirmed that expiration dates were not documented for media used for dermatophyte testing. D5781