Summary:
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 review of the laboratory procedure, lack of records, and staff interviews, the laboratory failed to verify the accuracy twice annually of histopathology testing for patient tissue samples removed during Micrographically Oriented Histopathology Surgery (MOHS) procedures in 2024. The findings include: 1. A review of the laboratory procedure titled "Proficiency Testing" revealed that "Semi Annually the Lab Technician will send two (2) cases" to an outside dermatopathologist, and the laboratory retained the reports in the Proficiency Testing Log of the procedure manual. 2. A review of the laboratory Proficiency Testing Log revealed that an outside dermatopathologist reviewed two cases in July 2024. Documentation of cases submitted to an outside dermatopathologist for a second date in 2024 was unavailable on the survey date (09/19/2025). The laboratory failed to verify accuracy twice annually in 2024. 3. An interview with the laboratory liaison on 09/19/2025 at 1:00 p. m. confirmed the survey findings. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing program. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure, lack of records, patient test record review, and staff interviews, the laboratory failed to verify the accuracy of potassium hydroxide (KOH) procedures used to detect yeast in patient samples twice annually in 2024. The findings include: 1. A review of the laboratory ' s Provider Performed Microscopy Lab Manual for the KOH patient testing procedures in the section "Evaluation of Proficiency/Split-Sample" revealed "To evaluate and demonstrate proficiency, at least twice per year split-sample testing is performed on at least two specimens for Quality Assurance. If two or less are performed in a year, split sample testing is performed on all samples". 2. On the date of the survey (09/19/2025), documentation of twice-annual verification of accuracy for KOH patient testing was not available. 3. A review of the laboratory ' s patient test log revealed the laboratory performed KOH testing on patients 133208 on 01/11/2024 and 269063 on 04/04/2024. 4. An interview with the laboratory liaison on 09/19/2025 at 1:00 p.m. confirmed the survey findings. 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 observation of the laboratory, review of laboratory reagent log sheets, laboratory patient test logs, and staff interviews, the laboratory failed to ensure that stains used for patient tissue processing removed during Micrographic Oriented Histopathology Surgery (MOHS) procedures were not used beyond the manufacturer's expiration date in 2025 (three of eighteen months reviewed). The findings include: 1. Observation of the laboratory on 09/19/2025 at 11:00 a.m. revealed stains and reagents used to process patient tissue samples removed during MOHS procedures for histopathology testing. 2. A review of the laboratory's "Reagent Log Sheets" revealed the following: Eosin: Lot 164413 expiration date 01/31/2025 Lot 45020015 opened on 04/30/20255. The laboratory used the expired lot (164413) from 02/01/2025 through 04/29/2025. Hematoxylin: Lot 178711 expiration date 02/28/2025 Lot 222596 opened 04/30/2025. The laboratory used the expired lot (178711) from 03/01/2025 through 04 /29/2025. 3. A review of the laboratory's 2025 MOHS Case logbook revealed that the laboratory performed patient testing as follows: Patient cases M25-076 through M25- 243 from 02/01/2025 through 04/29/2025 (167 cases total). Patient cases M25-108 through M25-243 from 03/01/2025 through 04/29/2025 (135 cases total). 4. An interview with the laboratory liaison on 09/19/2025 at 1:00 p.m. confirmed the survey findings. -- 2 of 2 --