Summary:
Summary Statement of Deficiencies D0000 An onsite initial certification survey was conducted on 10/01/2026. The laboratory was found to be in compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 direct observation, manufacturer's instructions, environmental logs, and confirmed in staff interview the laboratory failed to ensure the room humidity for 1 of 1 Olympus BX46 Clinical Microscope was maintained according to manufacturer's instructions for 1 of 1 month in 2025 (December) and 9 of 9 months in 2026 (January- September). Findings included: 1. During a tour of the laboratory director's office on 10/01/2026 at 10:09 AM, the surveyor observed an Olympus BX46 Clinical Microscope (Serial # 6G45608) on a desk. 2. Review of the Olympus BX46 Clinical Microscope instructions manual page 29 stated: "Item 9. Operating environment Specification ... Maximum relative humidity: 80% for temperatures up to 31 degrees C (88 degrees F), decreasing linearly through 70% at 34 degrees C (93 degrees F), to 50% relative humidity at 40 degrees C (104 degrees F)." 3. Review of the laboratory's environmental logs titled "TEMPERATURE MONITORING" from December 2025 through September 2026 revealed the laboratory failed to document and ensure 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 6 -- room humidity was maintained according to manufacturer's instructions of a maximum of 80%. 4. During an interview 10/01/2026 at 10:09 AM, the laboratory director after a review of records confirmed the laboratory failed to ensure the room humidity for 1 of 1 Olympus BX46 Clinical Microscope was maintained according to manufacturer's instructions for 1 of 1 month in 2025 (December) and 9 of 9 months in 2026 (January-September). Word Key: C- Celsius F- Fahrenheit D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: I. Based on review of laboratory policies, laboratory records, quality control records, annual test volume records, and confirmed in staff interview, the laboratory failed to define and document the intended reactivity for 1 of 1 Hematoxylin and Eosin (H & E) stain to ensure predictable staining characteristics of quality control slides for H & E staining on each day of patient testing for 215 of 215 days from December 2025 to September 2026. Findings included: 1. Review of the laboratory policy titled "Quality Control" revealed the laboratory failed to specify the intended reactivity for H & E stains to ensure predictable staining characteristics. 2. Review of laboratory records revealed that all histology, oral pathology and cytology specimens for the laboratory were sent to a reference laboratory for grossing and H&E staining, immunohistochemical and special staining. The slides were shipped back to the laboratory for pathological interpretation. 3. A review of the laboratory's "Daily Quality Control Log" from December 2, 2026, through September 30, 2026, revealed the following: The log had a column for "Stain Quality," each day stain quality was documented with a "checkmark" in the column and was initialed by the pathologist. The log did not specify if the "checkmark" column was indicated for H&E intended reactivity to ensure predictable staining characteristics. 4. According to laboratory records, the laboratory's annual volume was 1655 histology tests, 5 oral pathology tests and 60 cytology tests. 5. During an interview on 10/01/2026 at 10:05 AM, the laboratory director confirmed the laboratory failed to define and document the intended reactivity for 1 of 1 Hematoxylin and Eosin (H & E) stain to ensure predictable staining characteristics of quality control slides for H & E staining on each day of patient testing for 215 of 215 days from December 2025 to September 2026. II. Based on review of laboratory policies, laboratory records, quality control records, and confirmed in staff interview, the laboratory failed to define the intended reactivity for 19 of 19 special and immunohistochemical stains to ensure predictable staining characteristics of quality control slides each day of patient testing for 82 of 82 days from December 2025 to September 2026. Findings included: 1. Review of the laboratory policy titled "Quality Control" stated: "Special Stains: Special stains are performed by [XX], [XX] or other CLIA accredited lab. Upon review of the slides the stain quality control log is completed and retained.