Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey was conducted 08/18/2026 with the following standard level deficiencies 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: I. Based on direct observation, review of manufacturer's operator's manual, laboratory environmental records, and staff interview, the laboratory failed to ensure room temperatures were within the manufacturer's specifications for 18 of 18 days. Findings included: 1. During a tour of the laboratory areas on 08/18/2026 at 12:15 pm, a Benchmark Ultra automated immunohistochemical staining instrument was observed. 2. The manufacturer's operator's manual (1021470EN Version 1) stated, " ...Operating Temperature 20C to 32C (68F to 90F) ..." 3. Review of the laboratory's environmental record for May 2026 revealed an acceptable room temperature range of 64 F to 74F (degrees Fahrenheit). The laboratory's acceptable lower temperature of 64F exceeded the manufacturer's specified temperature of 68F. 4. In an interview on 08/18/2026 at 1: 15 pm, the General Supervisor confirmed the findings. II. Based on direct observation, review of reagent specifications, laboratory environmental records, and staff interview, the laboratory failed to ensure 1 of 1 bottle of Silver Nitrate, 10% Aqueous was stored according to manufacturer's specifications for 11 of 11 months. Findings 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 -- included: 1. During a tour of the laboratory areas on 08/18/2026 at 12:15 pm, one bottle of NewcomerSupply Silver Nitrate, 10% Aqueous (Lot number 2520426; Expiration date 08/5/2027) was observed in the laboratory's MagicChef refrigerator. Written on the reagent label was a received date of "10/6/25". 2. On the reagent label, the manufacturer stated, "Store at 15-30C". 3. Review of the laboratory's environmental records showed an acceptable temperature range of 2C to 8C for the MagicChef refrigerator. 4. In an interview on 08/18/2026 at 1:15 pm, the General Supervisor confirmed the findings. 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: Based on direct observations, review the laboratory's policies and procedures, Hematoxylin & Eosin (H&E) stain records, and staff interview, the laboratory failed to define and document H&E intended reactivity to ensure predictable staining characteristics for 59 of 59 days (manual staining) and 20 of 20 days (automated staining). Findings included: 1. During a tour of the laboratory areas on 08/18/2026 at 12:15 pm, two areas for slide staining were observed. The upstairs laboratory performed manual H&E staining for MOHS procedures. The downstairs laboratory performed H&E staining using the automated Sakura Tissue-Tek Prisma stainer. 2. Review of the laboratory's policies/procedures titled "Quality Control Maintenance" (Policy # CP-L 1017), "Manual Staining Procedure- Hematoxylin & Eosin (Policy # CP-L 2015) and "Staining Slides with Sakura Tissue-Tek Prisma" revealed the laboratory failed to define the H&E intended reactivity for predictable staining characteristics. 3. Review of the laboratory's H&E staining record titled "MOHS staining & Microscope QC log" from 02/24//2026 through 05/27/2026 revealed a check mark for "stain quality". The form did not provide an explanation or acceptable criteria for the check mark. Further review of the laboratory's record for automated H&E staining from May 2026 titled "Skin Pathology Associates" revealed the form provided a space for the quality of Hematoxylin stain and Eosin stain with a "grade" of "1-Excellent, 2-Fair, 3-Acceptable, 4-Deficient, 5-Unacceptable". The document did not provide an explanation of the intended reactivity associated with each "grade". 4. In an interview on 08/18/2026 at 1:15 pm, the General Supervisor confirmed that the laboratory did not define H&E intended reactivity. -- 2 of 2 --