Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 09/08/2026. The laboratory was found in substantial compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. 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 laboratory's policies/procedures, test accuracy verification records, patient test records and staff interview, the laboratory failed to follow its own policies and ensure test accuracy verification was documented at least twice annually for two of two required test accuracy verification events in 2025. Findings included: 1. Review of laboratory's "Mohs Quality Assurance Manual" (last reviewed 01/19 /2026) revealed: "Comparison of Test Results ... Any test performed in the laboratory for which proficiency testing is not available will be verified at least twice a year and the Laboratory Director will review the results." 2. Review of laboratory's policy "MOHS MICROGRAPHIC SURGERY SKIN SPECIMENS" (last reviewed 01/19 /2026) revealed: "Semi-annually, 2 cases will be randomly selected by the histotechnologist and will be submitted to a Board-Certified Dermatopathologist /Dermatologist for review. ... The slide will be labeled "Proficiency Test" by the sending laboratory for the records of the reference laboratory." 3. Review of laboratory's test verification records revealed the laboratory did not have documentation of the semi-annual test accuracy verification studies for the two of two required test accuracy verifications in 2025. 4. Review of laboratory's submitted annual test volumes revealed the laboratory performed testing on approximately 50 specimens from Mohs cases annually. 5. In an interview on 09/08/2026 at 1120 hours 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 -- in the breakroom, the facility's Laboratory Director (as indicated on submitted Form CMS 209) confirmed the findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, temperature/humidity logs and staff interview, the laboratory failed to ensure laboratory's humidity was documented for fourteen of thirty days in April 2026. Findings included: 1. Review of laboratory's policy "Room Temperature and Humidity ..." (last reviewed 01/19/2026) revealed: "ROOM TEMPERATURE AND HUMIDITY MUST BE IN THIS RANGE ... HUMIDITY MAX 60%" 2. Review of laboratory's temperature/humidity logs revealed the laboratory did not document level of humidity in the laboratory for fourteen days in April 2026, from 04/01/2026 through 04/14/2026. 3. In an interview on 09/08/2026 at 1120 hours in the breakroom, the facility's Laboratory Director (as indicated on submitted Form CMS 209) confirmed the 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 surveyor's observations, review of patient test logs and staff interview, the laboratory failed to ensure reagents were not used beyond their expiration date for one of one bottle of "Expedia Neg-50" frozen section medium in use in July and August 2026. Findings included: 1. Surveyor's observation on 09/08/2026 at 1005 in the laboratory revealed the following expired bottle of Expedia Neg-50 frozen section medium in use: Lot: 138122 Expiration date: 2026-07-03 There were no other bottles of Neg-50 solution found in the laboratory. 2. Review of laboratory's patient test logs revealed the following patient case samples were prepared using the expired Expedia Neg-50 frozen section medium: On 07/30/2026 Cases number: 26-021 26-022 26-023 26-024 On 08/27/2026 Cases number: 26-025 26-026 26-027 26-028 26-029 26-030 26-031 3. In an interview on 09/08/2026 at 1120 hours in the breakroom, the facility's Laboratory Director (as indicated on submitted Form CMS 209) confirmed the findings. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) -- 2 of 3 -- (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of laboratory's policies/procedures, equipment maintenance logs, annual test volumes and staff interview, the laboratory failed to document microscope cleaning maintenance for ten of the ten testing dates from May 2025 through August 2026. Findings included: 1. Review of laboratory's policy "CARE OF THE MICROSCOPE" (last reviewed 01/19/2026) revealed: "2. Clean the lens frequently with lens paper ... 3. Remove immersion oil immediately after use." 2. Review of laboratory's equipment maintenance logs revealed the laboratory did not have documentation of cleaning of the microscope and/or immersion oil removal after use for any of the ten days of testing from May 2025 through August 2026. 3. Review of laboratory's submitted annual test volumes revealed the laboratory performed testing on approximately 50 specimens from Mohs cases annually. 4. In an interview on 09/08 /2026 at 1120 hours in the breakroom, the facility's Laboratory Director (as indicated on submitted Form CMS 209) confirmed the findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on surveyor's observations, review of laboratory's policies/procedures, temperature/humidity logs, equipment maintenance logs, patient test logs/test volumes, quality assurance (QA) and staff interview the laboratory's QA failed to identify and correct issues in analytic systems regarding use of expired reagents, laboratory humidity monitoring and equipment maintenance. Refer to D5413, D5417 and D5433. -- 3 of 3 --