Summary:
Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) documentation and interview with the facility personnel, the laboratory failed to document the acceptability of Hematoxylin & Eosin staining materials each day of use for intended reactivity to ensure predictable staining characteristics. Findings include: 1. The laboratory performs the microscopic interpretation of Mohs specimens under the sub-specialty of Histopathology, with an approximate annual test volume of 530. The laboratory performs the Hematoxylin and Eosin (H & E) stain on each specimen prior to the microscopic interpretation. 2. The laboratory failed to perform and document the H & E stain acceptability each day of use for intended reactivity to ensure predictable staining characteristics for testing that occurred on the following dates: 1/25/2023, 1/24/2023, 1/11/2023, 1/10/2023, 10/05 /2022, 9/22/2022, 9/21/2022, 8/25/2022, 4/20/2021, 4/19/2021, 4/05/2021, 3/30/2021, 3/29/2021, 3/16/2021, 3/15/2021, 3/01/2021, and 1/18/2021. 3. The number of patient specimens tested using the H & E Stain on the testing dates indicated above could not be determined at the time of the survey. 4. The facility personnel interviewed on February 13, 2023 at 1:45pm confirmed the laboratory failed to document the H&E stain acceptability for intended reactivity to ensure predictable staining characteristics on the testing dates indicated above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) 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 -- (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of established quality assessment (QA) policies and procedures for review and interview with the facility personnel, the laboratory failed to follow established QA policies and procedures to monitor, assess and correct errors found in the analytic systems specified in 493.1251 through 493.1283. Findings include: 1. The laboratory performs the microscopic interpretation of Mohs specimens under the sub- specialty of Histopathology, with an approximate annual test volume of 530. The laboratory performs the Hematoxylin and Eosin (H & E) stain on each specimen prior to interpretation. 2. The laboratory's established QA policy titled, "Yuma-Laboratory Quality Assurance Policy" states, "The clinic laboratory shall randomly pick at a minimum two (2) patient samples, including slides, Mohs map, procedure note, and pathology report, at least twice a year to be audited for accuracy." 3. The laboratory's audit (QA) documentation presented for review from 2021 and 2022 failed to identify and correct errors found with the lack of performance of the Hematoxylin and Eosin (H & E) stain acceptability each day of patient testing. See D5473 for findings. 4. During the survey conducted on February 13, 2023, the laboratory presented