Summary:
Summary Statement of Deficiencies D5006 MYCOLOGY CFR(s): 493.1203 If the laboratory provides services in the subspecialty of Mycology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records, lack of documentation and interview with the laboratory manager (LM); the laboratory failed to meet the requirements specified for mycology testing in 2023 and 2024, affecting nine patient test results. Findings include: 1. The laboratory failed to document the required procedure manual items not provided by the manufacturer's "Remel Intended Use" insert for the mycology test Dermatophyte Test Medium (DTM), affecting nine of nine patient test results (DTM PT - 1 through DTM PT - 9) in 2023 and 2024. (Refer to D5405). 2. The laboratory failed to follow the manufacturer's instructions for mycology test Dermatophyte Test Medium (DTM) in 2023, affecting seven of eight DTM patent tests (DTM PT 1 - 4 and DTM PT 6 - 8). (Refer to D5411). 3. The laboratory failed to verify the performance specifications for the mycology test procedure Dermatophyte Test Medium (DTM) prior to patient testing (DTM PT) in 2023 and 2024, affecting nine of nine patient test results (DTM PT - 1 through DTM PT - 9). (Refer to D5421). 4. The laboratory failed to document positive and negative quality control materials for the mycology qualitative test procedure Dermatophyte Test Medium (DTM) for nine of nine patient test dates (DTM PT - 1 through DTM PT - 9) in 2023 and 2024. (Refer to D5449). 5. The laboratory failed to check each batch of Dermatophyte Test Medium (DTM) for the ability to select specific organisms and produce a biochemical response prior to the initial use of DTM for nine of nine patient tests (DTM PT - 1 through DTM PT - 9) in 2023 and 2024. (Refer to D5477). D5405 PROCEDURE MANUAL Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on review of laboratory records, lack of documentation and interview with the laboratory manager (LM); the laboratory failed to document the required procedure manual items not provided by the manufacturer's "Remel Intended Use" insert for the mycology test Dermatophyte Test Medium (DTM), affecting nine of nine patient test results (DTM PT - 1 through DTM PT - 9) in 2023 and 2024. Findings include: 1. Review of the manufacturer's "Remel Intended Use" insert for the DTM mycology test revealed no documentation of all of the required procedure manual items listed in the State Operations Manual (SOM) - Appendix C Standard 493.1251. Documentation is required for the following items: a) Patient preparation, specimen collection, labeling, storage, preservation, transportation, and criteria for specimen acceptability and rejection. b) Step - by - step performance of the procedure and interpretation of results. c) Preparation of controls, reagents, and other materials used in testing. d) The reportable range for test results as established or verified. e) Control procedures. f)