Regency Specialties

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on lack of monthly calibration records from July 2025 through October 2025 for the Hamamatsu Nanozoomer S20 Digital Slide Scanner and interview with the Testing Personnel (TP-2) on 11/19/25 at 1:44 PM, the laboratory failed to perform and document monthly calibration procedures on the scanner as required by the manufacturer. Findings include: 1. The laboratory began using the Hamamatsu Nanozoomer S20 Digital Slide Scanner on 6/24/2025 to perform patient testing in the subspecialty of Histopathology, with a reported annual test volume of 17,000. 2. The manufacturer's instructions indicate a monthly scanner calibration must be performed using calibration slides and blank slides provided by Hamamatsu. 3. The laboratory failed to perform and document monthly scanner calibrations from July 2025, August 2025, September 2025 and October 2025. 4. TP-2 interviewed on 11/19/25 at 1:44 PM acknowledged that the laboratory failed to provide evidence of monthly scanner calibrations for the timeframe indicated 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 D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must 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. The laboratory must 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 lack of a microscope maintenance policy and interview with the laboratory director, the laboratory failed to establish a microscope maintenance policy that indicates specific routine maintenance procedures, as well as scheduled preventative maintenance procedures. Findings include: 1. No documentation was presented for review during the survey performed on June 15, 2022 to indicate the laboratory established a microscope maintenance policy, including routine and preventative maintenance. 2. The laboratory director acknowledged that no microscope maintenance policy was established by the laboratory. 3. The laboratory's annual test volume under the sub-specialty of Histopathology is approximately 19,200. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) 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 -- The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of pathology test records and interview with the laboratory director, the laboratory failed to maintain a record system that includes the identity of the individual who performs the gross description on histopathology specimens. Findings include: 1. The laboratory performs the gross description on skin biopsies under the sub-specialty of Histopathology, with an approximate annual test volume of 19,200. The laboratory utilizes an EMR (Electronic Medical Record) to maintain patient test records and test reports. 2. No documentation was presented for review during the survey performed on June 15, 2022 to indicate the laboratory maintained a record system to include the identity of the personnel who performs the gross description on pathology specimens. 3. The laboratory director confirmed the laboratory failed to maintain a record system at the time of the survey that includes the identity of the testing personnel who performs the gross description on patient specimens. -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the laboratory's test reports for Mohs testing, test records for Mohs testing and interview with the facility personnel, the laboratory failed to include the test result on one test report reviewed during the survey. Findings include: 1. The laboratory began Mohs testing in the sub-specialty of Histopathology on 06/04/2019, with an approximate annual test volume of 950. The laboratory utilizes an electronic medical record (EMR) system to document the test procedure and test results. 2. One out of three Mohs test reports reviewed during the survey (M19-218) failed to include the final test result for Mohs. The Mohs Map for this patient indicated 2 stages were performed. The EMR reviewed for this patient failed to include information regarding Stage 2, including the final test result. 3. The facility personnel confirmed that the EMR for case# M19-218 failed to include the final test result. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of Mohs surgery slides, Mohs map, patient test reports, Mohs patient log and interview with the facility personnel, the laboratory failed to identify errors found with patient identification for one out of three Mohs cases reviewed. Findings include: 1. Review of the Mohs patient test log and the Mohs slides for case# M20- 013 indicated the patient name as M.S. 2. Review of the Mohs Map and Mohs test report (maintained in an electronic system) for case# M20-013 indicated the patient name as T.S. 3. The facility personnel confirmed that the patients' name referenced above was incorrectly listed on the slides and on the Mohs patient log. -- 2 of 2 --