Summary:
Summary Statement of Deficiencies D0000 Based on an on-site initial certification survey conducted on June 11, 2026, deficiencies were cited for Dermatology Center of the Rockies in Estes Park, Colorado. 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 surveyor review of daily quality control (QC) logs and patient testing records, and a telephone interview with testing personnel (TP1), the laboratory failed to ensure that staining materials were tested for positive and negative reactivity each day of use for 4 of 6 days of patient testing reviewed in 2026. The findings include: 1. Surveyor review of the laboratory's daily QC logs and patient testing records revealed that patient testing using staining materials was performed on six dates in 2026: January 8, February 5, March 26, April 2, May 7, and June 4, 2026. 2. Further review of the daily QC logs showed that the laboratory only documented QC performance on January 8, 2026, and February 5, 2026. The laboratory lacked any documentation indicating that the required daily QC (testing materials for intended reactivity) was performed on the remaining 4 days of patient testing: March 26, 2026; April 2, 2026; May 7, 2026; and June 4, 2026. 3. During a telephone interview on June 11, 2026, at 12:24 PM, TP1 confirmed that all required QC should be documented in the daily log and that the QC performance was missing for those 4 dates of patient testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --