Summary:
Summary Statement of Deficiencies D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on direct observation, lack of documentation and interview with the laboratory director (LD), the laboratory failed to have adequate guidelines for monitoring temperature and humidity and failed to monitor temperature and humidity in the secondary slide storage room in 2025. Findings include: 1. During a tour of the laboratory on 11/05/2025 at 10:17 am, no temperature or humidity monitoring devices were observed in the secondary slide storage room. 2. The laboratory failed to provide requested policy for temperature and humidity monitoring of slide storage areas. 3. A request was made for documentation of temperature and humidity monitoring of the secondary slide storage room in 2025, none was provided. 4. During an interview on 11/05/2025 at 10:50 with the LD, the LD indicated that the secondary slide storage room is not monitored for temperature or humidity, which confirms the above findings. 5. The laboratory reported 740 MOHs test in 2025. 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 review of the Center for Medicare and Medicaid (CMS) 209 personnel form, review of the laboratory's "KOH (Potassium Hydroxide) Log", review of the 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 -- laboratory's "KOH Proficiency Testing" policy, lack of documentation, and interview with the technical consultant (TC), three testing personnel (TP) performing KOH testing failed to participate in twice annual evaluation of KOH testing in 2025. Findings include: 1. A review of the CMS 209 personnel form listed four individuals as moderate complexity testing personnel (TP2, TP3, TP4, and TP5) performing KOH testing. 2. A review of the laboratory's "KOH Log" revealed three personnel (TP3, TP4, and TP5) performed KOH testing in 2025. 3. A review of the laboratory's "KOH Proficiency Testing" policy indicated evaluation of KOH testing is required to be performed and documented twice yearly for personnel performing testing. 4. The laboratory failed to provide documentation of TP3, TP4, and TP5's participation in twice annual evaluation of KOH testing. 5. An interview on 11/05/2025 at 10:03 am with the TC confirmed the above findings. 6. The laboratory reported 6 KOH tests in 2025. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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: Based on direct observation, review of the laboratory's "KOH (Potassium Hydroxide) Log", and interview with the laboratory director (LD), the laboratory failed to ensure reagents are not used beyond their expiration dates between March and September 2025. Findings include: 1. During a tour of the laboratory on 11/05/2025 at 10:17 am, a bottle of KOH (Lot 3072) with an expiration of 03/13/2025 was observed in use in the laboratory. 2. A review of the laboratory's "KOH Log" indicated KOH testing was performed 03/07/2025, 04/09/2025, 04/10/2025, 04/28/2025, 06/05/2025, and 09/08 /2025 3. An interview on 11/05/2025 at 11:36 am with the LD indicated the bottle of KOH was used during the dates referenced above. 4. The laboratory reported 6 KOH tests between March and September 2025. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) (e)(11) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on review of the Center for Medicare and Medicaid (CMS) 209 personnel form, review of the laboratory's "KOH (Potassium Hydroxide) Log", review of the laboratory's "KOH Initial Training" policy, lack of documentation, and interview with the laboratory director (LD), the LD failed to ensure personnel had documentation of initial training prior to patient testing for three of four testing personnel (TP) performing KOH testing in 2025. Findings include: 1. A review of the CMS 209 personnel form listed four individuals as moderate complexity testing personnel (TP2, TP3, TP4, and TP5) performing KOH testing. 2. A review of the laboratory's "KOH Log" revealed three personnel (TP3, TP4, and TP5) performed KOH testing in 2025. -- 2 of 3 -- 3. A review of the laboratory's "KOH Initial Training" policy stated "All providers will have an initial training checklist that will ensure they have completed and understood KOH protocols. Training Checklist will be filed in the provider folder". 4. A request was made for documentation of initial training for TP3, TP4, and TP5 for KOH testing, none was provided. 5. During an interview on 11/05/2025 at 10:03 am with the LD, the LD indicated initial trainings were not documented for TP3, TP4, and TP5 which confirms the above findings. 6. The laboratory reported 6 KOH tests between January and November 2025. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on review of the Center for Medicare and Medicaid (CMS) 209 personnel form, review of the laboratory's "KOH (Potassium Hydroxide) Log", review of the laboratory's "KOH Quality Control Competency Assessment" policy, lack of documentation, and interview with the technical consultant (TC), the TC failed to ensure personnel had documentation of competency assessment for three of four testing personnel (TP) performing KOH testing in 2025. Findings include: 1. A review of the CMS 209 personnel form listed four individuals as moderate complexity testing personnel (TP2, TP3, TP4, and TP5) performing KOH testing. 2. A review of the laboratory's "KOH Log" revealed three personnel (TP3, TP4, and TP5) performed KOH testing in 2025. 3. A review of the laboratory's "KOH Quality Control Competency Assessment" policy indicated KOH competency assessments are required to be performed and documented quarterly. 4. A request was made for documentation of competency assessment for TP3, TP4, and TP5 for KOH testing, none was provided. 5. During an interview on 11/05/2025 at 10:03 am with the TC, the TC indicated no competency assessments have been performed for TP3, TP4, and TP5 which confirms the above findings. 6. The laboratory reported 6 KOH tests in 2025. -- 3 of 3 --