Issc Fruitland

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of laboratory fungal logs, patient reports and an interview with the laboratory lead on 3/15/2022, the laboratory failed to follow manufacturer's instructions when using dermatophyte test medium. The finding include: 1. A review of the dermatophyte test medium (DTM) instructions for use from Hardy Diagnostics identified that the appearance of white aerial hyphae with red color around the fungal growth is positive for the presence of dermatophyte and a negative result is growth without a color change to red. 2. A review of the patient log for fungal cultures identified that the laboratory failed to follow the manufacturer's instructions and identified organisms other than dermatophyte from the DTM. 3. A review of patient report identified that the laboratory failed to only report positive or negative for dermatophyte from the DTM. 4. An interview with the laboratory lead on 3/15/2022 at 2:45 pm confirmed that the laboratory reported yeast from the DTM without further testing. 5. The laboratory reports 441 dermatophyte cultures annually. 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 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and an interview with the laboratory manager on 11/18/2020 at 09:30 am, the laboratory failed to verify the accuracy, at least twice annually, for Potassium Hydroxide (KOH) and Dermatophyte Fungal Cultures. The findings include: 1. A record review of the laboratory's "in-house PT" policy and "in-house PT" log sheets revealed that there was no documentation for biannual verification of accuracy for KOH and Dermatophyte Fungal Cultures from the time of the previous survey on 04/03/18 to this survey date (11/18/20). 2. The laboratory was performing "in-house proficiency testing" with known manufactured quality control organisms, in which 3 of 3 testing personnel knew the expected result(s) prior to performing both KOH and Dermatophyte Fungal Culture for biannual verification of accuracy. 3. An interview with the laboratory manager on 11/18/20 at 09:30 am confirmed that biannual verification had not been performed on unknown or blind samples for both KOH and Dermatophyte Fungal Cultures. 4. Prior to assigning the known specimens for subsequent biannual verification of accuracy testing, the laboratory did not rename the known quality control material with differing identifiers to make them an unknown or blind sample for biannual verification of accuracy. 5. The laboratory reports performing 834 KOH test annually, and 266 Dermatophyte Fungal Cultures annually. 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 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review and an interview with the nursing supervisor, the laboratory failed to establish the quality control plan (QCP) and the quality assurance plan (QAP) for the Dermatophyte test media as part of the Individualized Quality Control Plan (IQCP) since the last survey on April 26, 2016. Findings: 1. An IQCP review of the dermatophyte fungal culture test performed on Hardy Diagnostics Derm-Duet media, revealed the laboratory failed to establish the QCP and the QAP since the last survey. 2. An interview on April 3, 2018 at 10:00 AM, with the nursing supervisor, confirmed the laboratory failed to write the QCP and the QAP for the dermatophyte fungal test. 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 --