Summary:
Summary Statement of Deficiencies D0000 A recertification survey was completed on 7/12/2023. It was determined that the following condition-level deficiencies existed: 42 C.F.R. 493.1203 Condition: Mycology 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 observation, document review and interview, the laboratory failed to: 1) perform twice annual verification of accuracy in the subspecialty of Mycology (KOH- Potassium Hydroxide and Dermatophyte Testing) (refer to D5217); 2) include the following policies: step-by-step performance, control procedures, limitations of the test methodology, or the system for reporting patient results in their procedure manual (refer to D5403); 3) remove expired reagents (KOH-Potassium Hydroxide) used for testing performed in 2021 (Refer to 5417); 4) check each lot number and shipment of Dermatophyte Test Medium (DTM) for positive and negative reactivity (Refer to D5471). 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Repeat Deficiency Based on observation, document review and interview, the laboratory failed to perform twice annual verification of accuracy in the subspecialty of Mycology (KOH-Potassium Hydroxide and Dermatophyte Testing -DT) for KOH testing in 2021 and four (PT#6-PT#9) of four patients with DT reviewed in 2023. Findings include: 1) During a tour of the laboratory area on 7/12/2023 at 9:45 am the following was observed: a) One bottle of "KOH 10% Potassium Hydroxide" Reorder # KOH/10/2. b) Three bottles of "Delasco Alcohol". c) Four bottles with Dermatophyte Test Medium (DTM) with patient specimens were being processed. d) There were no additional vials of Dermatophyte Test Medium in the laboratory. 2.) In interview on 7/12/2023 at 10:23 am, SP-1 (Medical Assistant) indicated the Dermatophyte Test Medium is stored in the refrigerator but there is none left. They must have used that last of it with the current four patients. Upon request for a log for Dermatophyte testing, SP-1 indicated a log is not kept, documentation is stored in the medical record. 3) Review of the "Indiana State Department of Health CLIA Certification Program Enclosure I Test Methodology and Annual Test Volume Log" signed by the laboratory director on 7/12/2023 indicated the laboratory performed approximately 10 KOH test annually, with a note "Stopped January 1, 2022", and 10 DTM. 4) Review of patient charts for the four patient's specimens processed in DTM during the tour indicated the following: PT#=patient number PT# Date Chart Note: PT#6 6/26/23 DTM Obtained PT#7 6/29/23 DTM Obtained PT#8 6/28/23 DTM Obtained PT#9 6/9/23 DTM Obtained There was no documentation in the chart of any of the DTM being read or final determination. 5) Review of the document "ACU- DTM (Dermatophyte Test Medium) Directions for Use" no date, indicated the following: "ACU-DTM" is available in boxes containing 24 vials each. 6) Review of the "CLIA Program" binder indicated there was no twice annual verification for KOH in 2021. There were two letters dated November 16, 2021, and January 1, 2023, stating the laboratory director and another physician agreed "to exchange mycology (KOH- potassium hydroxide slides for CLIA proficiency testing peer review ..." There was no documentation of peer review for KOH. There was no policy for twice annual verification of Dermatophyte testing and no documentation of verification being performed. 7) Upon request for KOH testing performed in 2021, on 7/12/2023 at 12: 15 pm SP#2 (laboratory director) indicated they do not have a log for KOH testing. The results are documented in the chart but there is no way to find a specific patient who had KOH testing. 8) Upon request a log of testing or documentation of twice annual verification for Dermatophyte Testing on 7/12/2023 at 12:03 pm, SP-1 (Medical Assistant) indicated there was no twice annual verification performed for dermatophyte testing and no log is kept. 9) In interview on 7/12/23 at 12:40 pm, SP-2 (laboratory director) confirmed there was no twice annual verification of accuracy performed in 2021 for KOH nor in 2023 for dermatophyte testing. 10) Annual testing volume for KOH in 2021 is approximately 10 and annual test volume for DTM is 10. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in -- 2 of 6 -- 493.1253. (7) Control procedures. (8)