Regency Specialties

Summary Statement of Deficiencies 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 temperature records from 2025, review of laboratory policy and interview with the facility personnel on 8/21/26 at 1:08 PM, the laboratory failed to monitor and document the room temperature where patient testing occurred on 11 out of 11 testing dates between October 28, 2025 and November 26, 2025. Findings include: 1. The laboratory performs the microscopic interpretation of Mohs specimens in the subspecialty of histopathology. The laboratory's reported annual test volume is 3,200. 2. The laboratory's established room temperature range is 70-75 degrees Fahrenheit. It is the policy of the laboratory to monitor and document the room temperature of the area where Mohs specimens are processed each day of patient testing. 3. The laboratory failed to monitor and document the room temperature of the area where Mohs specimens are processed on 11 out of 11 testing dates between October 28, 2025 and November 26, 2025. 4. Approximately 220 patients were tested between October 28, 2025 and November 26, 2025. 5. The facility personnel interviewed on 8/21/26 at 1:08 PM confirmed that the laboratory failed to monitor and document the room temperature of the laboratory on the testing dates referenced above. 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 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's established Quality Assessment policies, review of QA records and interview with the facility personnel, the laboratory failed to identify and correct errors found within the accuracy verification process. Findings include: 1. The laboratory performs a microscopic examination and diagnosis on tissue specimens in conjunction with Mohs testing under the sub-specialty of Histopathology, with an approximate annual test volume of 2,400. 2. It is the practice of the laboratory to randomly select four completed Mohs cases each quarter which are reviewed by another qualified Mohs physician to verify accuracy of the testing. The review is documented on the "Quality Assurance, proficiency testing" form. 3. The laboratory's established policy titled, "Quality Assurance Program" states, "Peer review will be documented as proficiency testing is scheduled....A